T2DM is a global epidemic with

Size: px
Start display at page:

Download "T2DM is a global epidemic with"

Transcription

1 : a new option for the management of type 2 diabetes Marc Evans MRCP, MD, Consultant Diabetologist, Llandough Hospital, Cardiff Incretin-based therapies for the treatment of diabetes mellitus (T2DM) present a new approach to disease management. Over recent years, several new drugs have entered the marketplace, and NICE have recently issued guidance on how best to incorporate these new drugs into treatment regimens. In this article, Marc Evans reviews saxagliptin, a dipeptidyl peptidase- IV (DPP-IV) inhibitor, and considers its potential clinical use. T2DM is a global epidemic with an estimated prevalence of 6% (246 million people) worldwide in 2007, which is forecast to rise to 7.3% (380 million people) by Progressive impairment of beta-cell function and increased insulin demand as tissue becomes insulin resistant are core pathophysiological defects in the development and progression of hyperglycaemia in T2DM. Other important factors are also known to further exacerbate this pathology, including excess alpha cell glucagon secretion, abnormal gastric emptying during hyperglycaemia, obesity and increased food intake. 2 The incretin pathway, in particular glucagon-like peptide (GLP-1) and, to a lesser extent, glucosedependent insulinotropic polypeptide (GIP), plays an important role in modulating islet cell function, gastric emptying and satiety. DPP-IV Islet of Langerhans cells. DPP-IV inhibitors like saxagliptin enhance glucose-stimulated insulin release (beta cells) and decrease glucagon release (alpha cells). is the enzyme responsible for the initial rapid degradation of both GLP-1 and GIP. 3 These peptides are incretin hormones that primarily enhance glucose-stimulated insulin secretion, upregulate all steps in insulin biosynthesis, and enhance glucose-mediated suppression in alpha cell glucagon release. 3 In T2DM, incretin actions are impaired, 3,4 but exogenously infused GLP-1 can normalise both fasting and postprandial glucose concentrations (FPG and PPG respectively). 4 When given by continuous subcutaneous infusion over six weeks, GLP-1 improved beta-cell function, resulting in lowered glucose profiles and reduced glycated haemoglobin (HbA 1c ) levels, and was associated with weight loss and minimal risk of hypoglycaemia. 5 However, because of its rapid degradation, native GLP-1 cannot be used therapeutically; consequently there has been much interest in the role of agents that utilise the potential therapeutic benefits of the incretin pathway. 6 Two classes of therapy have subsequently been developed. The first class are the GLP-1 receptor agonists (exenatide, liraglutide, taspoglutide), which are structurally similar to human GLP-1, exerting similar agonist effects at the GLP-1 receptor. These have sufficient structural differences to human GLP-1 to render them resistant to degradation by DPP-IV. The second class of incretin-based therapies to have been developed are a group of agents that selectively and reversibly inhibit the activity of DPP-IV. GLP-1 receptor agonists are injectable therapies that result in Skyline Imaging Ltd FUTURE PRESCRIBER VOL 10(3) 13

2 DPP-IV inhibitors GLP-1 and GIP enhanced Oral Increased levels of GLP-1 in physiological range Dependent upon endogenous GLP-1/GIP Comparable efficacy to thiazolidinediones and sulphonylureas Well tolerated Weight neutral around a 10-fold increase in plasma GLP-1 levels, while DPP-IV inhibitors are oral therapies that result in around a four-fold increase in plasma GLP-1 levels. 7 Due to the glucose-dependent effects of GLP-1, both GLP-1 agonists and DPP-IV inhibitors are associated with a low risk of hypoglycaemia, while due to the differing plasma GLP-1 levels, GLP-1 agonists are associated with modest weight reduction ( 2.2 to 3.1kg), while DPP-IV inhibitors are associated with weight neutrality ( 0.2 to +0.8kg). 7 The different plasma GLP-1 levels may also largely account for the different tolerability profiles of the incretin therapies, with gastrointestinal sideeffects, in particular nausea, being the most common adverse event associated with GLP-1 agonists, occurring at a frequency of up to 44%. However, in clinical trials, <5% of patients withdrew due to nausea. 7 By contrast, DPP-IV inhibitors are associated with minimal gastrointestinal side-effects. 7 (Table 1 summarises the differing properties of GLP-1 agonists and DPP-IV inhibitors.) A number of DPP-IV inhibitors have entered clinical development. Of these, sitagliptin and vildagliptin have been approved and are now available for the treatment of T2DM. Alogliptin is awaiting GLP-1 agonists Pure GLP-1 effect Injectable Supraphysiological levels of GLP-1 Not limited by endogenous secretion Nausea Weight loss Table 1. Comparison of the therapeutic profiles of DPP-IV inhibitors and GLP-1 agonists regulatory approval, and others (eg BI1356) are in phase 3 clinical trials. is currently undergoing regulatory review by the Food and Drug Administration in the USA and the European Medicines Agency in Europe. The most recent NICE guidance 8 advocates DPP-IV inhibitors as an alternative second-line addon to metformin in place of a sulphonylurea (SU) in people in whom there is a significant concern regarding hypoglycaemia, when control of blood glucose remains inadequate despite maximal tolerated metformin monotherapy. PHARMACOLOGY is a selective, durable but reversible inhibitor of DPP-IV. 9 At 37 C, it has an inhibition constant (Ki) of 1.3±0.3nM for DPP-IV inhibition, which is 10-fold more potent than either vildagliptin (13±3nM) or sitagliptin (18±2nM). 9 demonstrates greater specificity for DPP-IV than for either the DPP-VIII or DPP-IX enzymes (400- and 75-fold, respectively). 9 The active metabolite of saxagliptin (BMS ) is two-fold less potent than the parent drug. Both saxagliptin and its metabolite are highly selective (>4000-fold) for the inhibition of DPP-IV compared with a range of other proteases (selectivity of sitagliptin and vildagliptin for DPP-IV is >2600 and fold, respectively, compared with DPP-VIII/IX). shows a high sensitivity for DPP-IV (the half maximal inhibitory concentration [IC50] = 3.5, 18, and 26nM for vildagliptin, sitagliptin and saxagliptin, respectively). 10 Conversely, saxagliptin demonstrates a low affinity for DPP-VIII and DPP-IX (IC50 for DPP-VIII = IX and >50nM for vildagliptin and sitagliptin, respectively; IC50 for DPP-IX = >50nM for sitagliptin). 10 Age and gender do not appear to have a significant impact on the pharmacokinetic properties of saxagliptin, 11 while a less than two-fold difference was observed for the pharmacokinetics of saxagliptin, or its active metabolite, in patients with any category of hepatic impairment compared with healthy individuals, suggesting that no dose adjustment is required for saxagliptin in people with hepatic impairment. 11 Since saxagliptin is cleared by both metabolism and renal excretion, a recent study was conducted to evaluate the effects of renal impairment and haemodialysis on the pharamacokinetics of saxagliptin. 12 In this study the degree of renal impairment did not affect the C max of saxagliptin or its major metabolite. In mild renal impairment subjects, the overall mean systemic exposure (AUC ) values of saxagliptin and its major metabolite were 1.2- and 1.7-fold higher, respectively, than mean AUC values in subjects with normal renal function. The saxagliptin and metabolite AUC values in moderate renal impairment subjects were 1.4- and 2.9-fold higher, respectively, than subjects with normal renal function. The corresponding values in severe renal impairment subjects were 2.1- and 14 FUTURE PRESCRIBER VOL 10(3)

3 4.5-fold higher, respectively. A four-hour haemodialysis session removed 23% of the saxagliptin dose. Based on these data, saxagliptin may have potential clinical utility in people with renal impairment, and larger studies are ongoing to fully evaluate the effects of saxagliptin, its efficacy and its safety in people with varying degrees of renal impairment. EFFECTS ON GLYCAEMIC CONTROL There have been several phase 3 trials assessing the effectiveness of saxagliptin-based therapy in groups of patients with T2DM. Treatmentnaïve patients with T2DM (HbA 1c 7 10%; n=401) were treated with saxagliptin once daily (2.5, 5 and 10mg) for 24 weeks, with an additional open-label cohort (HbA 1c, >10% and 12%; n=66) being treated with saxagliptin 10mg once daily for 24 weeks. 13 Figure 1 demonstrates the reductions in HbA 1c achieved with saxagliptin over a dose range mg. Significant (p<0.0075) reductions in FPG compared with placebo were observed in all saxagliptin treatment arms (15 23mg/dL), with reductions observed as early as week two. also reduced PPG AUC and resulted in significantly greater numbers of patients achieving an HbA 1c target <7%. 13 The efficacy and safety of saxagliptin has also been studied in patients with T2DM inadequately controlled by treatment with metformin, a thiazolidinedione (TZD) or an SU alone At week 24, once-daily saxagliptin (2.5 10mg) as an add-on treatment to stable metformin provided significant (p<0.0001) reductions in HbA 1c ( %) compared with placebo. 14 In the TZD study, 565 patients with inadequate glycaemic control (HbA 1c %) were randomised to receive add-on therapy with saxagliptin (2.5 or 5mg) or placebo once daily, in addition to either pioglitazone (30 or 45mg) or rosiglitazone (4 or 8mg) for 24 weeks. 16 At week 24, saxagliptin (2.5 and 5mg) add-on treatment provided significant adjusted-mean reductions in HbA 1c from baseline ( 0.66% and 0.94%, respectively) compared with placebo ( 0.30%; both p<0.001). In the SU study, 768 patients with T2DM inadequately controlled (HbA 1c %) with glyburide 7.5mg alone were randomised to receive saxagliptin 2.5 or 5mg, or glyburide 2.5mg in addition to open-label glyburide for 24 weeks. 15 Blinded uptitration of glyburide to a maximum of 15mg daily was permitted in the glyburide treatment arm only. At week 24, saxagliptin 2.5 and 5mg add-on treatment provided significant (p<0.0001) adjusted-mean reductions in HbA 1c ( 0.54% and 0.64%, respectively), compared with an increase for uptitrated glyburide (0.08%). In all of these studies, saxagliptin resulted Adjusted mean change in haemoglobin A 1c (% ±SEM) in more patients achieving an HbA 1c target of <7%, along with significant reductions in both FPG and PPG levels. Initial combination therapy with saxagliptin plus metformin has also been investigated in drugnaïve patients with inadequate blood glucose control (HbA 1c 8 12%; n=1306). 17 Patients were treated with saxagliptin (5 or 10mg) plus metformin 500mg or placebo, in addition to either saxagliptin 10mg alone or metformin 500mg alone, for 24 weeks. (5 and 10mg) initial combination therapy with metformin provided significant (p<0.001) reductions in HbA 1c ( 2.53% and 2.49%, respectively), FPG ( 59.8 and 62.2mg/dL, respectively), PPG at 120 minutes during an oral glucose tolerance test (OGTT) ( and 137.3mg/dL, respectively), and improved beta-cell function (homeostasis model [HOMA beta]; 33% and 38%, respectively), compared with saxagliptin 10mg alone (HbA 1c, 1.69%; FPG, 30.9mg/dL; Dose placebo 2.5mg 5mg 10mg 20mg 40mg Figure 1. Significant reductions in HbA 1c are achieved with saxagliptin across a dose range from 2.5 to 40mg daily 13 FUTURE PRESCRIBER VOL 10(3) 15

4 PPG, 106.3mg/dL; HOMA beta, 18.2%) or metformin 500mg alone (HbA 1c 1.99%; FPG, 47.3mg/dL; PPG, 96.8mg/dL; HOMA beta, 22.6%). SAFETY AND TOLERABILITY as monotherapy and in combination with other antidiabetic drugs has demonstrated a good safety and tolerability profile in multiple randomised trials in patients with T2DM. 9,11 In doseranging studies, there were no apparent dose-related adverse events, and the frequency of adverse events was comparable between saxagliptin and placebo. 9 The most common adverse events reported have been headache, upper respiratory tract infection, urinary tract infection, and nasopharyngitis, seen during the 12-week study with doses up to 40mg and during the 24-week study with doses up to 10mg. 18 Small, reversible, dose-dependent reductions in absolute lymphocyte count were observed that were more apparent at doses 20mg, which did, however, remain within normal limits. 18 There was no effect on white blood cell or neutrophil count, and no evidence of altered immune function based on adverse event reporting. 9,11,18 has been well tolerated when used in combination treatment. There was no difference in the occurrence of adverse events when used in combination with metformin compared with metformin alone, and saxagliptin was well tolerated when added to an SU, with the adverse event profile being similar to that of uptitrated glyburide alone. The combination of saxagliptin with a TZD was also well tolerated, with no clinically meaningful differences in adverse events between the treatment groups is metabolised to its active metabolite by cytochrome P450 CYP3A4/5, but does not inhibit or induce CYP3A4. In numerous studies, saxagliptin has not been shown to influence the pharmacokinetic profile of a variety of drugs including statins, ketoconizole, digoxin and diltiazem. 9 Drugs that inhibit CYP3A4/5, such as ketoconizole and diltiazem, when co-administered with saxagliptin, have been shown to increase the AUC and C max for saxagliptin. 9 Therefore, dosage adjustment of saxagliptin may be required when it is co-administered with such agents. HYPOGLYCAEMIA AND WEIGHT GAIN In all clinical studies, either as monotherapy or in combination, saxagliptin therapy appears to have minimal effects on body weight. 9,11 In monotherapy, hypoglycaemic symptoms were experienced by 6.3% of saxagliptin-exposed subjects in the low-dose (2.5 40mg) cohort (versus 1.5% on placebo) and by 13.6% of subjects in the high-dose (100mg) cohort (versus 0% with placebo). 13 However, at doses of up to 10mg, it has not been associated with any increased incidence of hypoglycaemia relative to placebo. When added to an SU, 15 hypoglycaemic events were reported by 14% of patients receiving combination therapy with saxagliptin (2.5 or 5mg), which was similar to that reported by the glyburide arm (10%), with the occurrence of confirmed hypoglycaemia (fingerstick glucose 50mg/dL) being similar in all three arms (2.4%, 0.8% and 0.7% for saxagliptin 2.5 and 5mg, and glyburide uptitration, respectively). A low incidence of hypoglycaemia was reported by those patients taking saxagliptin together with a TZD (4.1% and 2.7% for the 2.5 and 5mg doses), compared with 3.8% for TZD monotherapy, and only a single case of confirmed hypoglycaemia (fingerstick glucose 50mg/dL) occurred (2.5mg saxagliptin arm). THERAPEUTIC APPLICATIONS Traditional treatment strategies for patients with T2DM have generally used a stepwise, failure-based approach to medication selection. Simply stated, this approach features the sequential addition of therapies only when glycaemic control deteriorates significantly. Early aggressive intervention is now known to exert a legacy effect, even years after patients have opted out of intensive therapy protocols, fostering a sustained reduction in the risk of both micro- and macrovascular complications. 19 Consequently, the most recent NICE guidance on the management of blood glucose in people with T2DM advocates a stepwise approach to glucose-lowering therapy, aiming to produce optimal individualised HbA 1c targets. 8 Metformin, due to its long-term safety, efficacy and low cost, is recommended as the initial drug of choice for the majority of people once HbA 1c levels are 6.5%. Hypoglycaemia is the major consideration in the management of blood glucose. Severe hypoglycaemia is associated with increased mortality rates, 8 while the fear of hypoglycaemia is a recognised barrier to the achievement of glucose control and has a markedly negative impact on quality of life. 20 Hypoglycaemia avoidance is thus a key feature in the management of blood glucose and is of particular relevance when treatment is intensified to achieve lower HbA 1c targets. The most recent NICE 16 FUTURE PRESCRIBER VOL 10(3)

5 guidance 8 advocates DPP-IV inhibitors (because of their low risk of hypoglycaemia) as an alternative second-line add-on to metformin in place of a sulphonylurea in people in whom there is a significant concern regarding hypoglycaemia, when control of blood glucose remains inadequate (HbA 1c 6.5%) despite maximal tolerated metformin monotherapy. Such treatment should only be continued if the person has had a beneficial metabolic response (a reduction of at least 0.5% in HbA 1c in six months). DPP-IV inhibitors, due to their general weight neutrality, are considered to be preferable to a TZD in people in whom further weight gain would cause or exacerbate problems associated with high body weight. All available data suggest that saxagliptin can be used as monotherapy or in combination with other antidiabetic agents, while once-daily administration might also increase patient compliance. The lack of an increased risk of hypoglycaemia and the neutral effect on weight thus makes saxagliptin a viable therapy option according to the current guidelines. CONCLUSIONS is a novel and highly selective DPP-IV inhibitor that has recently completed phase 3 clinical trials. It is an oral antidiabetic agent that is administered once daily and produces significant reductions in HbA 1c, fasting and postprandial glucose levels when used as monotherapy or in combination with metformin, SUs or TZDs. Treatment with saxagliptin is well tolerated, does not result in a significant increase in hypoglycaemia and appears generally weight neutral. appears to be a useful additional therapeutic option, particularly in patients where hypoglycaemia and further weight gain may have detrimental effects on quality of life. REFERENCES 1. International Diabetes Federation. The Diabetes Atlas, 3rd edition. Brussels: International Diabetes Federation, Stumvoll M, Goldstein BJ, van Haeften TW. Type 2 diabetes: principles of pathogenesis and therapy. Lancet 2005;365: Holst JJ. The physiology of glucagon-like peptide 1. Physiol Rev 2007;87: Holst JJ, Vilsboll T, Deacon CF. The incretin system and its role in type 2 diabetes mellitus. Mol Cell Endocrinol 2009;297: Vilsboll T, Holst JJ. Incretins, insulin secretion and type 2 diabetes mellitus. Diabetologia 2004;47: Deacon CF, Holst JJ. Dipeptidyl peptidase IV inhibitors: a promising new therapeutic approach for the management of type 2 diabetes. Int J Biochem 2006;38: Kendall DM, Cuddihy RM, Bergenstal RM. Clinical application of incretin-based therapy: therapeutic potential, patient selection and clinical use. Am J Med 2009;122(Suppl):S National Institute of Health and Clinical Excellence. Clinical guideline 87: Type 2 diabetes: newer agents for blood glucose control in type 2 diabetes. May Tahrani AA, Piya MK, Barnett AH. : a new DPP-IV inhibitor for the treatment of type 2 diabetes. Adv Ther 2009;26: Barnett A. DPP-4 inhibitors and their potential role in the management of type 2 diabetes. Int J Clin Pract 2006;60: Deacon CF, Holst JJ. : a new dipeptidyl peptidase-4 inhibitor for the treatment of type 2 diabetes. Adv Ther 2009; 26: Boulton D, Tang A, Patel C, et al. Pharmacokinetics of the dipeptidyl peptidase- 4 inhibitor saxagliptin in subjects with renal impairment. Endocrine Abstracts 2009;20:P Rosenstock J, Aguilar-Salinas CA, Klein E, et al. Once-daily saxagliptin monotherapy improves glycemic control in drug-naïve patients with type 2 diabetes. Presented at: 68th Scientific Session of the American Diabetes Association; June 6 19, 2008; San Francisco, USA. Abstract 517-P. 14. Defronzo RA, Hissa M, Blauwet MB, et al. added to metformin improves glycemic control in patients with type 2 diabetes. Presented at: 67th Scientific Session of the American Diabetes Association; June 22 26, 2007; Chicago, USA. Abstract 0285-OR. 15. Ravichandran S, Chacra AR, Tan GH, et al. added to a sulfonylurea is safe and more efficacious than up-titrating a sulfonylurea in patients with type 2 diabetes. Presented at: 44th annual meeting of the European Society for the Study of Diabetes; September 7 11, 2008; Rome, Italy. Abstract. 16. Allen E, Hollander P, Li L, et al. added to a thiazolidinedione improves glycemic control in patients with inadequately controlled type 2 diabetes. Presented at: 44th annual meeting of the European Society for the Study of Diabetes; September 7 11, 2008; Rome, Italy. Abstract. 17. Chen R, Pfützner A, Jadzinsky M, et al. Initial combination therapy with saxagliptin and metformin improves glycemic control compared with either monotherapy alone in drugnaïve patients with type 2 diabetes. Presented at: 44th annual meeting of the European Society for the Study of Diabetes; September 7 11, 2008; Rome, Italy. Abstract. 18. Rosenstock J, Sankoh S, List JF. Glucose-lowering activity of the dipeptidyl peptidase-4 inhibitor saxagliptin in drug-naive patients with type 2 diabetes. Diabetes Obes Metab 2008;10: Hollman RR, Paul SK, Bethel A, et al. 10-Year follow-up of intensive glucose control in type 2 diabetes. N Engl J Med 2008;359: Amiel SA, Dixon T, Mann R, et al. Hypoglycaemia in type 2 diabetes. Diabet Med 2008;25: FUTURE PRESCRIBER VOL 10(3) 17

Sitagliptin: first DPP-4 inhibitor to treat type 2 diabetes Steve Chaplin MSc, MRPharmS and Andrew Krentz MD, FRCP

Sitagliptin: first DPP-4 inhibitor to treat type 2 diabetes Steve Chaplin MSc, MRPharmS and Andrew Krentz MD, FRCP Sitagliptin: first DPP-4 inhibitor to treat type 2 diabetes Steve Chaplin MSc, MRPharmS and Andrew Krentz MD, FRCP KEY POINTS sitagliptin (Januvia) is a DPP-4 inhibitor that blocks the breakdown of the

More information

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Single Technology Appraisal. Canagliflozin in combination therapy for treating type 2 diabetes

NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE. Single Technology Appraisal. Canagliflozin in combination therapy for treating type 2 diabetes NATIONAL INSTITUTE FOR HEALTH AND CARE EXCELLENCE Single Technology Appraisal Canagliflozin in combination therapy for Final scope Remit/appraisal objective To appraise the clinical and cost effectiveness

More information

GLP-1 agonists. Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK

GLP-1 agonists. Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK GLP-1 agonists Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK What do GLP-1 agonists do? Physiology of postprandial glucose regulation Meal ❶ ❷ Insulin Rising plasma

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium saxagliptin, 5mg film-coated tablet (Onglyza ) No. (603/10) Bristol-Myers Squibb Pharmaceuticals Ltd 05 February 2010 The Scottish Medicines Consortium (SMC) has completed

More information

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008

National Horizon Scanning Centre. Saxagliptin (BMS ) for type 2 diabetes. April 2008 Saxagliptin (BMS 477118) for type 2 diabetes This technology summary is based on information available at the time of research and a limited literature search. It is not intended to be a definitive statement

More information

Management of Type 2 Diabetes

Management of Type 2 Diabetes Management of Type 2 Diabetes Pathophysiology Insulin resistance and relative insulin deficiency/ defective secretion Not immune mediated No evidence of β cell destruction Increased risk with age, obesity

More information

Role of incretins in the treatment of type 2 diabetes

Role of incretins in the treatment of type 2 diabetes Role of incretins in the treatment of type 2 diabetes Jens Juul Holst Department of Medical Physiology Panum Institute University of Copenhagen Denmark Diabetes & Obesity Spanish Society of Internal Medicine

More information

Practical Strategies for the Clinical Use of Incretin Mimetics CME/CE. CME/CE Released: 09/15/2009; Valid for credit through 09/15/2010

Practical Strategies for the Clinical Use of Incretin Mimetics CME/CE. CME/CE Released: 09/15/2009; Valid for credit through 09/15/2010 Practical Strategies for the Clinical Use of Incretin Mimetics CME/CE Robert R. Henry, MD Authors and Disclosures CME/CE Released: 09/15/2009; Valid for credit through 09/15/2010 Introduction Type 2 diabetes

More information

Chief of Endocrinology East Orange General Hospital

Chief of Endocrinology East Orange General Hospital Targeting the Incretins System: Can it Improve Our Ability to Treat Type 2 Diabetes? Darshi Sunderam, MD Darshi Sunderam, MD Chief of Endocrinology East Orange General Hospital Age-adjusted Percentage

More information

Incretin-based Therapies for Type 2 Diabetes Comparisons Between Glucagon-like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors

Incretin-based Therapies for Type 2 Diabetes Comparisons Between Glucagon-like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors Incretin-based Therapies for Type 2 Diabetes Comparisons Between Glucagon-like Peptide-1 Receptor Agonists and Dipeptidyl Peptidase-4 Inhibitors Timothy Bailey, MD, FACE, CPI Director, AMCR Institute,

More information

Disclosure. Learning Objectives. Case. Diabetes Update: Incretin Agents in Diabetes-When to Use Them? I have no disclosures to declare

Disclosure. Learning Objectives. Case. Diabetes Update: Incretin Agents in Diabetes-When to Use Them? I have no disclosures to declare Disclosure Diabetes Update: Incretin Agents in Diabetes-When to Use Them? I have no disclosures to declare Spring Therapeutics Update 2011 CSHP BC Branch Anar Dossa BScPharm Pharm D CDE April 20, 2011

More information

COMMISSIONING POLICY RECOMMENDATION TREATMENT ADVISORY GROUP Policy agreed by (Vale of York CCG/date)

COMMISSIONING POLICY RECOMMENDATION TREATMENT ADVISORY GROUP Policy agreed by (Vale of York CCG/date) Drug, Treatment, Device name ( Vipidia; Takeda) COMMISSIONING POLICY RECOMMENDATION TREATMENT ADVISORY GROUP Policy agreed by (Vale of York CCG/date) Licensed indication To improve glycaemic control in

More information

Current Status of Incretin Based Therapies in Type 2 Diabetes

Current Status of Incretin Based Therapies in Type 2 Diabetes Current Status of Incretin Based Therapies in Type 2 Diabetes DR.M.Mukhyaprana Prabhu Professor of Internal Medicine Kasturba Medical College, Manipal, Manipal University, India 2 nd International Endocrine

More information

The Many Faces of T2DM in Long-term Care Facilities

The Many Faces of T2DM in Long-term Care Facilities The Many Faces of T2DM in Long-term Care Facilities Question #1 Which of the following is a risk factor for increased hypoglycemia in older patients that may suggest the need to relax hyperglycemia treatment

More information

DPP-4/SGLT2 inhibitor combined therapy for type 2 diabetes

DPP-4/SGLT2 inhibitor combined therapy for type 2 diabetes THERAPY REVIEW DPP-4/SGLT2 inhibitor combined therapy for type 2 diabetes STEVE CHAPLIN SPL DPP-4 inhibitors and SGLT2 inhibitors lower blood glucose by complementary mechanisms of action, and two fixeddose

More information

GLP 1 agonists Winning the Losing Battle. Dr Bernard SAMIA. KCS Congress: Impact through collaboration

GLP 1 agonists Winning the Losing Battle. Dr Bernard SAMIA. KCS Congress: Impact through collaboration GLP 1 agonists Winning the Losing Battle Dr Bernard SAMIA KCS Congress: Impact through collaboration CONTACT: Tel. +254 735 833 803 Email: kcardiacs@gmail.com Web: www.kenyacardiacs.org Disclosures I have

More information

Effect of macronutrients and mixed meals on incretin hormone secretion and islet cell function

Effect of macronutrients and mixed meals on incretin hormone secretion and islet cell function Effect of macronutrients and mixed meals on incretin hormone secretion and islet cell function Background. Following meal ingestion, several hormones are released from the gastrointestinal tract. Some

More information

Modulating the Incretin System: A New Therapeutic Strategy for Type 2 Diabetes

Modulating the Incretin System: A New Therapeutic Strategy for Type 2 Diabetes Modulating the Incretin System: A New Therapeutic Strategy for Type 2 Diabetes Geneva Clark Briggs, PharmD, BCPS Adjunct Professor at University of Appalachia College of Pharmacy Clinical Associate, Medical

More information

What s New in Type 2? Peter Hammond Consultant Physician Harrogate District Hospital

What s New in Type 2? Peter Hammond Consultant Physician Harrogate District Hospital What s New in Type 2? Peter Hammond Consultant Physician Harrogate District Hospital Therapy considerations in T2DM Thiazoledinediones DPP IV inhibitors GLP 1 agonists Insulin Type Delivery Horizon scanning

More information

Management of Type 2 Diabetes. Why Do We Bother to Achieve Good Control in DM2. Insulin Secretion. The Importance of BP and Glucose Control

Management of Type 2 Diabetes. Why Do We Bother to Achieve Good Control in DM2. Insulin Secretion. The Importance of BP and Glucose Control Insulin Secretion Management of Type 2 Diabetes DG van Zyl Why Do We Bother to Achieve Good Control in DM2 % reduction 0-5 -10-15 -20-25 -30-35 -40 The Importance of BP and Glucose Control Effects of tight

More information

Data from an epidemiologic analysis of

Data from an epidemiologic analysis of CLINICAL TRIAL RESULTS OF GLP-1 RELATED AGENTS: THE EARLY EVIDENCE Lawrence Blonde, MD, FACP, FACE ABSTRACT Although it is well known that lowering A 1c (also known as glycated hemoglobin) is associated

More information

Newer and Expensive treatment of diabetes. Endocrinology Visiting Associate Professor Institute of Medicine TUTH

Newer and Expensive treatment of diabetes. Endocrinology Visiting Associate Professor Institute of Medicine TUTH Newer and Expensive treatment of diabetes Jyoti Bhattarai MD Endocrinology Visiting Associate Professor Institute of Medicine TUTH Four out of every five people with diabetes now live in developing countries.

More information

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal

NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE. Proposed Health Technology Appraisal NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE Proposed Health Technology Appraisal Dapagliflozin in combination therapy for the Final scope Remit/appraisal objective To appraise the clinical and

More information

Drug Class Monograph

Drug Class Monograph Class: Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drug Class Monograph Drugs: alogliptin, Januvia (sitagliptin), Janumet (sitagliptin/metformin), Janumet XR (sitagliptin/metformin), Jentadueto (linagliptin/metformin),

More information

Scottish Medicines Consortium

Scottish Medicines Consortium Scottish Medicines Consortium liraglutide 6mg/mL prefilled pen for injection (3mL) (Victoza ) Novo Nordisk Ltd. No. (585/09) 06 November 2009 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

Drug Class Monograph

Drug Class Monograph Drug Class Monograph Class: Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drugs: alogliptin, alogliptin/metformin, Januvia (sitagliptin), Janumet (sitagliptin/metformin), Janumet XR (sitagliptin/metformin),

More information

IDF Regions and global projections of the number of people with diabetes (20-79 years), 2013 and Diabetes Atlas -sixth Edition: IDF 2013

IDF Regions and global projections of the number of people with diabetes (20-79 years), 2013 and Diabetes Atlas -sixth Edition: IDF 2013 IDF Regions and global projections of the number of people with diabetes (20-79 years), 2013 and 2035 Diabetes Atlas -sixth Edition: IDF 2013 Diabetes Atlas -sixth Edition: IDF 2013 Chronic complications

More information

Clinical Overview of Combination Therapy with Sitagliptin and Metformin

Clinical Overview of Combination Therapy with Sitagliptin and Metformin Clinical Overview of Combination Therapy with Sitagliptin and Metformin 1 Contents Pathophysiology of type 2 diabetes and mechanism of action of sitagliptin Clinical data overview of sitagliptin: Monotherapy

More information

sitagliptin, 25mg, 50mg and 100mg film-coated tablets (Januvia ) SMC No. (1083/15) Merck Sharp and Dohme UK Ltd

sitagliptin, 25mg, 50mg and 100mg film-coated tablets (Januvia ) SMC No. (1083/15) Merck Sharp and Dohme UK Ltd sitagliptin, 25mg, 50mg and 100mg film-coated tablets (Januvia ) SMC No. (1083/15) Merck Sharp and Dohme UK Ltd 07 August 2015 The Scottish Medicines Consortium (SMC) has completed its assessment of the

More information

Early treatment for patients with Type 2 Diabetes

Early treatment for patients with Type 2 Diabetes Israel Society of Internal Medicine Kibutz Hagoshrim, June 22, 2012 Early treatment for patients with Type 2 Diabetes Eduard Montanya Hospital Universitari Bellvitge-IDIBELL CIBERDEM University of Barcelona

More information

Bristol-Myers Squibb / AstraZeneca ADVICE dapagliflozin (Forxiga ) Indication under review: SMC restriction: Chairman, Scottish Medicines Consortium

Bristol-Myers Squibb / AstraZeneca ADVICE dapagliflozin (Forxiga ) Indication under review: SMC restriction: Chairman, Scottish Medicines Consortium Re-Submission dapagliflozin 5mg and 10mg film-coated tablets (Forxiga ) SMC No. (799/12) Bristol-Myers Squibb / AstraZeneca 07 February 2014 The Scottish Medicines Consortium (SMC) has completed its assessment

More information

Diabetes Management DPP-4 Inhibitors

Diabetes Management DPP-4 Inhibitors Drug Profile Saxagliptin, a Novel Dipeptidyl Peptidase-4 Inhibitor for the Treatment of Type 2 Diabetes Baptist Gallwitz, MD, PhD Professor of Medicine, Department of Medicine IV, Eberhard Karls University

More information

Type 2 DM in Adolescents: Use of GLP-1 RA. Objectives. Scope of Problem: Obesity. Background. Pathophysiology of T2DM

Type 2 DM in Adolescents: Use of GLP-1 RA. Objectives. Scope of Problem: Obesity. Background. Pathophysiology of T2DM Type 2 DM in Adolescents: Use of GLP-1 RA Objectives Identify patients in the pediatric population with T2DM that would potentially benefit from the use of GLP-1 RA Discuss changes in glycemic outcomes

More information

Non-insulin treatment in Type 1 DM Sang Yong Kim

Non-insulin treatment in Type 1 DM Sang Yong Kim Non-insulin treatment in Type 1 DM Sang Yong Kim Chosun University Hospital Conflict of interest disclosure None Committee of Scientific Affairs Committee of Scientific Affairs Insulin therapy is the mainstay

More information

Liraglutide: First Once-Daily Human GLP-1 Analogue

Liraglutide: First Once-Daily Human GLP-1 Analogue DRUG PROFILE KERALA MEDICAL JOURNAL Liraglutide: First Once-Daily Human GLP-1 Analogue Sreejith N Kumar Research Cell, IMA Kerala State, K-5, Kochar Road, Sasthamangalam Thiruvananthapuram* ABSTRACT Published

More information

Abstract. Effect of sitagliptin on glycemic control in patients with type 2 diabetes. Introduction. Abbas Mahdi Rahmah

Abstract. Effect of sitagliptin on glycemic control in patients with type 2 diabetes. Introduction. Abbas Mahdi Rahmah Effect of sitagliptin on glycemic control in patients with type 2 diabetes Abbas Mahdi Rahmah Correspondence: Dr. Abbas Mahdi Rahmah Consultant Endocrinologist, FRCP (Edin) Director of Iraqi National Diabetes

More information

GLP-1. GLP-1 is produced by the L-cells of the gut after food intake in two biologically active forms It is rapidly degraded by DPP-4.

GLP-1. GLP-1 is produced by the L-cells of the gut after food intake in two biologically active forms It is rapidly degraded by DPP-4. GLP-1 GLP-1 is produced by the L-cells of the gut after food intake in two biologically active forms It is rapidly degraded by DPP-4 Food intake éinsulin Gut églucose uptake Pancreas Beta cells Alpha cells

More information

Francesca Porcellati

Francesca Porcellati XX Congresso Nazionale AMD Razionali e Benefici dell Aggiunta del GLP-1 RA Short-Acting all Insulina Basale Francesca Porcellati Dipartimento di Medicina Interna, Sezione di Medicina Interna, Endocrinologia

More information

(Incretin) ( glucagon-like peptide-1 GLP-1 ) GLP-1. GLP-1 ( dipeptidyl peptidase IV DPP IV ) GLP-1 DPP IV GLP-1 exenatide liraglutide FDA 2 2 2

(Incretin) ( glucagon-like peptide-1 GLP-1 ) GLP-1. GLP-1 ( dipeptidyl peptidase IV DPP IV ) GLP-1 DPP IV GLP-1 exenatide liraglutide FDA 2 2 2 007 18 189-194 (Incretin) Incretin ( ) -1 ( glucagon-like peptide-1 ) ( dipeptidyl peptidase IV ) liraglutide FDA ( Type diabetes mellitus ) -1 ( Glucagon-like peptide-1, ) ( Incretin ) ( Dipeptidyl peptidase

More information

Scope. History. History. Incretins. Incretin-based Therapy and DPP-4 Inhibitors

Scope. History. History. Incretins. Incretin-based Therapy and DPP-4 Inhibitors Plasma Glucose (mg/dl) Plasma Insulin (pmol/l) Incretin-based Therapy and Inhibitors Scope Mechanism of action ผศ.ดร.นพ.ว ระเดช พ ศประเสร ฐ สาขาว ชาโภชนว ทยาคล น ก ภาคว ชาอาย รศาสตร คณะแพทยศาสตร มหาว ทยาล

More information

Multiple Factors Should Be Considered When Setting a Glycemic Goal

Multiple Factors Should Be Considered When Setting a Glycemic Goal Multiple Facts Should Be Considered When Setting a Glycemic Goal Patient attitude and expected treatment effts Risks potentially associated with hypoglycemia, other adverse events Disease duration Me stringent

More information

Sitagliptin. Agreed by Clinical Priorities Group

Sitagliptin. Agreed by Clinical Priorities Group New Medicine Report Document Status Sitagliptin Agreed by Clinical Priorities Group Traffic Light Decision Blue- Primary Care Prescriber s Rating Offers an advantage - The product has some value but does

More information

Optimal glucose control. DM Treatment. Glucose Control one out of many. Many guidelines: Confusing. Theorectically easy

Optimal glucose control. DM Treatment. Glucose Control one out of many. Many guidelines: Confusing. Theorectically easy DM Treatment How to Achieve Optimal Glycaemic Control The Tung Wah Eastern Hospital Experience of DM Share Care Experience Optimal glucose control Theorectically easy More challenging in the real world

More information

VICTOSA and Renal impairment DR.R.S.SAJAD

VICTOSA and Renal impairment DR.R.S.SAJAD VICTOSA and Renal impairment DR.R.S.SAJAD February 2019 Main effect of GLP-1 is : Stimulating glucose dependent insulin release from the pancreatic islets. Slow gastric emptying Inhibit inappropriate

More information

Diabetes: Three Core Deficits

Diabetes: Three Core Deficits Diabetes: Three Core Deficits Fat Cell Dysfunction Impaired Incretin Function Impaired Appetite Suppression Obesity and Insulin Resistance in Muscle and Liver Hyperglycemia Impaired Insulin Secretion Islet

More information

New Treatment Options for Type 2 Diabetes: Incretin-Based Therapy

New Treatment Options for Type 2 Diabetes: Incretin-Based Therapy New Treatment Options for Type 2 Diabetes: Incretin-Based Therapy New Treatment Options for Type 2 Diabetes: Incretin-Based Therapy is supported by an educational grant from Novo Nordisk Inc. This program

More information

Should Psychiatrists be diagnosing (and treating) metabolic syndrome

Should Psychiatrists be diagnosing (and treating) metabolic syndrome Should Psychiatrists be diagnosing (and treating) metabolic syndrome David Hopkins Clinical Director, Diabetes King s College Hospital, London Diabetes prevalence (thousands) Diabetes in the UK: 1995-2010

More information

YOU HAVE DIABETES. Angie O Connor Community Diabetes Nurse Specialist 25th September 2013

YOU HAVE DIABETES. Angie O Connor Community Diabetes Nurse Specialist 25th September 2013 YOU HAVE DIABETES Angie O Connor Community Diabetes Nurse Specialist 25th September 2013 Predicated 2015 figures are already met 1 in 20 have diabetes:1in8 over 60years old Definite Diagnosis is key Early

More information

Add-on saxagliptin improves glycemic status among uncontrolled type 2 diabetes mellitus

Add-on saxagliptin improves glycemic status among uncontrolled type 2 diabetes mellitus International Journal of Research in Medical Sciences Pradhan B et al. Int J Res Med Sci. 2018 May;6(5):1682-1686 www.msjonline.org pissn 2320-6071 eissn 2320-6012 Original Research Article DOI: http://dx.doi.org/10.18203/2320-6012.ijrms20181758

More information

DPP-4 inhibitor. The new class drug for Diabetes

DPP-4 inhibitor. The new class drug for Diabetes DPP-4 inhibitor The new class drug for Diabetes 1 Cause of Death in Korea 1 st ; Neoplasm 2 nd ; Cardiovascular Disease 3 rd ; Cerebrovascular Disease Diabetes 2 Incidence of Fatal or Nonfatal MI During

More information

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors In the Management of Diabetes

Dipeptidyl Peptidase-4 (DPP-4) Inhibitors In the Management of Diabetes DRUG CLASS REVIEW Dipeptidyl Peptidase-4 (DPP-4) Inhibitors In the Management of Diabetes Rolee Pathak, PharmD, RPh, BCPS; and Mary Barna Bridgeman, PharmD, RPh INTRODUCTION Type-2 diabetes mellitus is

More information

Utility of Saxagliptin in the Treatment of Type 2 Diabetes: Review of Efficacy and Safety

Utility of Saxagliptin in the Treatment of Type 2 Diabetes: Review of Efficacy and Safety Adv Ther (2015) 32:1065 1084 DOI 10.1007/s12325-015-0262-9 REVIEW Utility of Saxagliptin in the Treatment of Type 2 Diabetes: Review of Efficacy and Safety Rajeev Jain To view enhanced content go to www.advancesintherapy.com

More information

Type 2 diabetes: recent advances in diagnosis and management

Type 2 diabetes: recent advances in diagnosis and management DRUG REVIEW n Type 2 diabetes: recent advances in diagnosis and management Sudesna Chatterjee MD, FRCP and Melanie Davies MD, FRCP, FRCGP The expanding array of new type 2 diabetes agents and how to combine

More information

INJECTABLE THERAPY FOR THE TREATMENT OF DIABETES

INJECTABLE THERAPY FOR THE TREATMENT OF DIABETES INJECTABLE THERAPY FOR THE TREATMENT OF DIABETES ARSHNA SANGHRAJKA DIABETES SPECIALIST PRESCRIBING PHARMACIST OBJECTIVES EXPLORE THE TYPES OF INSULIN AND INJECTABLE DIABETES TREATMENTS AND DEVICES AVAILABLE

More information

PROCEEDINGS CLINICAL RESEARCH AND EXPERIENCE WITH INCRETIN-BASED THERAPIES * Vivian A. Fonseca, MD, FRCP ABSTRACT

PROCEEDINGS CLINICAL RESEARCH AND EXPERIENCE WITH INCRETIN-BASED THERAPIES * Vivian A. Fonseca, MD, FRCP ABSTRACT CLINICAL RESEARCH AND EXPERIENCE WITH INCRETIN-BASED THERAPIES Vivian A. Fonseca, MD, FRCP ABSTRACT Despite proven lifestyle recommendations and the availability of a range of oral antidiabetic agents,

More information

Dept of Diabetes Main Desk

Dept of Diabetes Main Desk Dept of Diabetes Main Desk 01202 448060 Glucose management in Type 2 Diabetes in Adults The natural history of type 2 diabetes is for HbA1c to deteriorate with time. A stepwise approach to treatment is

More information

Modulating the Incretin System: A New Therapeutic Strategy for Type 2 Diabetes. Overview. Prevalence of Overweight in the U.S.

Modulating the Incretin System: A New Therapeutic Strategy for Type 2 Diabetes. Overview. Prevalence of Overweight in the U.S. Modulating the Incretin System: A New Therapeutic Strategy for Type 2 Diabetes Geneva Clark Briggs, PharmD, BCPS Overview Underlying defects with Type 2 diabetes Importance of managing postprandial glucose

More information

Mechanisms and Clinical Efficacy of Lixisenatide for the Management of Type 2 Diabetes

Mechanisms and Clinical Efficacy of Lixisenatide for the Management of Type 2 Diabetes Adv Ther (2013) 30(2):81 101. DOI 10.1007/s12325-013-0009-4 REVIEW Mechanisms and Clinical Efficacy of Lixisenatide for the Management of Type 2 Diabetes Michael Horowitz Christopher K. Rayner Karen L.

More information

Volume : 05 Issue : 03 July-Sept Pages:

Volume : 05 Issue : 03 July-Sept Pages: Middle East Journal of Applied Sciences Volume : 05 Issue : 03 July-Sept. 2015 Pages: 695-699 Efficacy and Safety of Vildagliptin as Add-on Therapy in Patients with Type 2 Diabetes Mellitus Poorly Controlled

More information

TREATMENTS FOR TYPE 2 DIABETES. Susan Henry Diabetes Specialist Nurse

TREATMENTS FOR TYPE 2 DIABETES. Susan Henry Diabetes Specialist Nurse TREATMENTS FOR TYPE 2 DIABETES Susan Henry Diabetes Specialist Nurse How can we improve outcomes in Type 2 diabetes? Earlier diagnosis Better patient education Stress central role of lifestyle management

More information

Newer Drugs in the Management of Type 2 Diabetes Mellitus

Newer Drugs in the Management of Type 2 Diabetes Mellitus Newer Drugs in the Management of Type 2 Diabetes Mellitus Dr. C. Dinesh M. Naidu Professor of Pharmacology, Kamineni Institute of Medical Sciences, Narketpally. 1 Presentation Outline Introduction Pathogenesis

More information

Oral Agents. Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK

Oral Agents. Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK Oral Agents Ian Gallen Consultant Community Diabetologist Royal Berkshire Hospital Reading UK What would your ideal diabetes drug do? Effective in lowering HbA1c No hypoglycaemia No effect on weight/ weight

More information

Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes

Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes Liraglutide (Victoza) in combination with basal insulin for type 2 diabetes May 2011 This technology summary is based on information available at the time of research and a limited literature search. It

More information

CAMBRIDGESHIRE JOINT PRESCRIBING GROUP DECISION DOCUMENT Recommendation made by CJPG to Commissioners and Prescribers

CAMBRIDGESHIRE JOINT PRESCRIBING GROUP DECISION DOCUMENT Recommendation made by CJPG to Commissioners and Prescribers CAMBRIDGESHIRE JOINT PRESCRIBING GROUP DECISION DOCUMENT Recommendation made by CJPG to Commissioners and Prescribers Linagliptin (Trajenta, Boehringer Ingelheim Ltd) for the treatment of type 2 diabetes

More information

Sitagliptin: A component of incretin based therapy. Rezvan Salehidoost, M.D., Endocrinologist

Sitagliptin: A component of incretin based therapy. Rezvan Salehidoost, M.D., Endocrinologist Sitagliptin: A component of incretin based therapy Rezvan Salehidoost, M.D., Endocrinologist Agenda Mode of Action Evidences for sitagliptine cardiovascular safety of sitagliptin Ramadan study Impact of

More information

Clinical study on the therapeutic efficacy of the dipeptidyl peptidase 4 inhibitors, in type 2 diabetes

Clinical study on the therapeutic efficacy of the dipeptidyl peptidase 4 inhibitors, in type 2 diabetes UNIVERSITY OF MEDICINE AND PHARMACY OF CRAIOVA FACULTY OF MEDICINE Clinical study on the therapeutic efficacy of the dipeptidyl peptidase 4 inhibitors, in type 2 diabetes PhD Thesis Abstract Key words:

More information

GLP-1 (glucagon-like peptide-1) Agonists (Byetta, Bydureon, Tanzeum, Trulicity, Victoza ) Step Therapy and Quantity Limit Criteria Program Summary

GLP-1 (glucagon-like peptide-1) Agonists (Byetta, Bydureon, Tanzeum, Trulicity, Victoza ) Step Therapy and Quantity Limit Criteria Program Summary OBJECTIVE The intent of the GLP-1 (glucagon-like peptide-1) s (Byetta/exenatide, Bydureon/ exenatide extended-release, Tanzeum/albiglutide, Trulicity/dulaglutide, and Victoza/liraglutide) Step Therapy

More information

Update on Diabetes Mellitus

Update on Diabetes Mellitus Update on Diabetes Mellitus Treatment: Targeting the Incretin System Overview Underlying defects with Type 2 diabetes Importance of managing postprandial glucose control Amylin Incretin Hormones New therapies

More information

Oral Hypoglycemics and Risk of Adverse Cardiac Events: A Summary of the Controversy

Oral Hypoglycemics and Risk of Adverse Cardiac Events: A Summary of the Controversy Oral Hypoglycemics and Risk of Adverse Cardiac Events: A Summary of the Controversy Jeffrey Boord, MD, MPH Advances in Cardiovascular Medicine Kingston, Jamaica December 7, 2012 VanderbiltHeart.com Outline

More information

A New Therapeutic Strategey for Type II Diabetes: Update 2008

A New Therapeutic Strategey for Type II Diabetes: Update 2008 Live, One Hour Webinar A New Therapeutic Strategey for Type II Diabetes: Update 2008 Geneva Clark Briggs, PharmD, BCPS Adjunct Professor at University of Appalachia College of Pharmacy in Grundy, Virginia.

More information

la prise en charge du diabète de

la prise en charge du diabète de N21 XIII Congrès National de Diabétologie, 29 mai 2011, Alger Intérêt et place des Anti DPP4 dans la prise en charge du diabète de type 2 Nicolas PAQUOT, MD, PhD CHU Sart-Tilman, Université de Liège Belgique

More information

MOA: Long acting glucagon-like peptide 1 receptor agonist

MOA: Long acting glucagon-like peptide 1 receptor agonist Alexandria Rydz MOA: Long acting glucagon-like peptide 1 receptor agonist Increases glucose dependent insulin secretion Decreases inappropriate glucagon secretion Increases β- cell growth and replication

More information

Current evidence on the effect of DPP-4 inhibitor drugs on mortality in type 2 diabetic (T2D) patients: A meta-analysis

Current evidence on the effect of DPP-4 inhibitor drugs on mortality in type 2 diabetic (T2D) patients: A meta-analysis Current evidence on the effect of DPP-4 inhibitor drugs on mortality in type 2 diabetic (T2D) patients: A meta-analysis Raja Chakraverty Assistant Professor in Pharmacology Bengal College of Pharmaceutical

More information

Combination treatment for T2DM

Combination treatment for T2DM Combination treatment for T2DM Date of approval: December 2016 SAGLB.DIA.16.08.0657 Abbreviations ADA: American Diabetes Association CVD: Cardiovascular disease DPP-4: Dipeptidyl Peptidase-4 EASD: European

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Galvus 50 mg tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg of vildagliptin. Excipient: Each

More information

Le incretine: un passo avanti. Francesco Dotta

Le incretine: un passo avanti. Francesco Dotta Le incretine: un passo avanti Francesco Dotta U.O.C. Diabetologia, Policlinico Le Scotte Università di Siena Fondazione Umberto Di Mario ONLUS Toscana Life Science Park Incretins: multiple targets multiple

More information

New and Emerging Therapies for Type 2 DM

New and Emerging Therapies for Type 2 DM Dale Clayton MHSc, MD, FRCPC Dalhousie University/Capital Health April 28, 2011 New and Emerging Therapies for Type 2 DM The science of today, is the technology of tomorrow. Edward Teller American Physicist

More information

Efficacy and Safety of Sitagliptin in Various Clinical Settings of T2DM

Efficacy and Safety of Sitagliptin in Various Clinical Settings of T2DM Efficacy and Safety of Sitagliptin in arious Clinical Settings of T2DM Young Min Cho, MD, PhD Division of Endocrinology and Metabolism Department of Internal Medicine Seoul National University College

More information

Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drug Class Prior Authorization Protocol

Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drug Class Prior Authorization Protocol Dipeptidyl-Peptidase 4 (DPP-4) Inhibitors Drug Class Prior Authorization Protocol Line of Business: Medicaid P&T Approval Date: February 21, 2018 Effective Date: April 1, 2018 This policy has been developed

More information

Combination therapy with DPP-4 inhibitors and pioglitazone in type 2 diabetes: theoretical consideration and therapeutic potential

Combination therapy with DPP-4 inhibitors and pioglitazone in type 2 diabetes: theoretical consideration and therapeutic potential REVIEW Combination therapy with DPP-4 inhibitors and pioglitazone in type 2 diabetes: theoretical consideration and therapeutic potential Nasser Mikhail Endocrinology Division, Olive View-UCLA Medical

More information

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS

ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Januvia 25 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains sitagliptin phosphate monohydrate,

More information

exenatide 2mg powder and solvent for prolonged-release suspension for injection (Bydureon ) SMC No. (748/11) Eli Lilly and Company Limited

exenatide 2mg powder and solvent for prolonged-release suspension for injection (Bydureon ) SMC No. (748/11) Eli Lilly and Company Limited exenatide 2mg powder and solvent for prolonged-release suspension for injection (Bydureon ) SMC No. (748/11) Eli Lilly and Company Limited 09 December 2011 The Scottish Medicines Consortium (SMC) has completed

More information

Glucose Control drug treatments

Glucose Control drug treatments Glucose Control drug treatments It should be noted that glitazones are under suspicion of precipitating acute cardiac events and current recommendations contraindicate the use of glitazones in patients

More information

Barbara Cadario, BSc(Hon), BScPhm., MSc Barbara Cadario SAXAGLIPTIN

Barbara Cadario, BSc(Hon), BScPhm., MSc Barbara Cadario SAXAGLIPTIN Volume 31 (1) 2011 Editor: Barbara Cadario, BSc(Hon), BScPhm., MSc Contents - Saxagliptin Barbara Cadario Chairman, Medical Review Laird Birmingham, MD, MHSc, FRCP(C) TRADE NAME: Onglyza CLASSIFICATION

More information

Media Contacts: Amy Rose Investor Contact: Graeme Bell (908) (908)

Media Contacts: Amy Rose Investor Contact: Graeme Bell (908) (908) News Release FOR IMMEDIATE RELEASE Media Contacts: Amy Rose Investor Contact: Graeme Bell (908) 423-6537 (908) 423-5185 Tracy Ogden (267) 305-0960 FDA Approves Once-Daily JANUVIA, the First and Only DPP-4

More information

Diabetes Management DPP-4 Inhibitors

Diabetes Management DPP-4 Inhibitors Dipeptidyl Peptidase-4 Inhibitors and the Management of Hyperglycemia Pamela M Katz, MD 1 and Lawrence A Leiter, MD 2 1. Resident, Division of Endocrinology and Metabolism, University of Toronto; 2. Head,

More information

DPP-4 Inhibitors: Strategies for PPG Control

DPP-4 Inhibitors: Strategies for PPG Control Issue 2 Clinical Use o f In c r e t i n-based Therapies to Tr e at Type 2 Diabetes Term of Approval Release date: August 2009 Expiration date: August 31, 2010 DPP-4 Inhibitors: Strategies for PPG Control

More information

GLP-1-based therapies in the management of type 2 diabetes

GLP-1-based therapies in the management of type 2 diabetes GLP-1-based therapies in the management of type 2 diabetes Makbul Aman Mansyur Division Endocrine & Metabolism Department of Internal Medicine Faculty of Medicine Hasanuddin University/ RSUP Dr. Wahidin

More information

Drug Class Review Newer Diabetes Medications and Combinations

Drug Class Review Newer Diabetes Medications and Combinations Drug Class Review Newer Diabetes Medications and Combinations Final Update 2 Report July 2016 The purpose reports is to make available information regarding the comparative clinical effectiveness and harms

More information

Expanding Treatment Options for Diabetes: GLP-1 Receptor Agonists. Copyright

Expanding Treatment Options for Diabetes: GLP-1 Receptor Agonists. Copyright CLINICAL Viewpoint Expanding Treatment Options for Diabetes: GLP-1 Receptor Agonists Advancements in Diabetes Management: A Canadian Diabetes Steering Committee Report Copyright Not for Sale or Commercial

More information

CADTH Optimal use report

CADTH Optimal use report Canadian Agency for Drugs and Technologies in Health Agence canadienne des médicaments et des technologies de la santé CADTH Optimal use report Volume 3, Issue 1D July 2013 Optimal Use Recommendations

More information

Drugs used in Diabetes. Dr Andrew Smith

Drugs used in Diabetes. Dr Andrew Smith Drugs used in Diabetes Dr Andrew Smith Plan Introduction Insulin Sensitising Drugs: Metformin Glitazones Insulin Secretagogues: Sulphonylureas Meglitinides Others: Acarbose Incretins Amylin Analogues Damaglifozin

More information

Int. J. Pharm. Sci. Rev. Res., 22(2), Sep Oct 2013; nᵒ 21,

Int. J. Pharm. Sci. Rev. Res., 22(2), Sep Oct 2013; nᵒ 21, Research Article A Comparative Study to Evaluate the Efficacy and Safety of Vildagliptin as an Add-on Therapy to a Low-Dose Metformin vs an Uptitration of Metformin in Type 2 DM Patients Basavaraj Bhandare*

More information

Diabetes Care Publish Ahead of Print, published online September 22, 2008

Diabetes Care Publish Ahead of Print, published online September 22, 2008 Diabetes Care Publish Ahead of Print, published online September 22, 2008 Efficacy and Safety of the Dipeptidyl Peptidase-4 Inhibitor Alogliptin in Patients With Type 2 Diabetes Mellitus and Inadequate

More information

Treatment Options for Diabetes: An Update

Treatment Options for Diabetes: An Update Treatment Options for Diabetes: An Update A/Prof. Marg McGill Manager, Diabetes Centre Dr. Ted Wu Staff Specialist Endocrinologist Diabetes Centre Centre of Health Professional Education Education Provider

More information

Initiating Insulin in Primary Care for Type 2 Diabetes Mellitus. Dr Manish Khanolkar, Diabetologist, Auckland Diabetes Centre

Initiating Insulin in Primary Care for Type 2 Diabetes Mellitus. Dr Manish Khanolkar, Diabetologist, Auckland Diabetes Centre Initiating Insulin in Primary Care for Type 2 Diabetes Mellitus Dr Manish Khanolkar, Diabetologist, Auckland Diabetes Centre Outline How big is the problem? Natural progression of type 2 diabetes What

More information

Diabetes 2013: Achieving Goals Through Comprehensive Treatment. Session 2: Individualizing Therapy

Diabetes 2013: Achieving Goals Through Comprehensive Treatment. Session 2: Individualizing Therapy Diabetes 2013: Achieving Goals Through Comprehensive Treatment Session 2: Individualizing Therapy Joshua L. Cohen, M.D., F.A.C.P. Professor of Medicine Interim Director, Division of Endocrinology & Metabolism

More information

It is estimated that approximately 20.8 million Americans

It is estimated that approximately 20.8 million Americans FORMULARY MANAGEMENT Managed Care Perspective on Three New Agents for Type 2 Diabetes Shawna VanDeKoppel, PharmD; Hae Mi Choe, PharmD, CDE; and Burgunda V. Sweet, PharmD, FASHP ABSTRACT BACKGROUND: Despite

More information

PRODUCT INFORMATION VICTOZA. liraglutide

PRODUCT INFORMATION VICTOZA. liraglutide Victoza_pi6a.docx Page 1 of 21 PRODUCT INFORMATION VICTOZA liraglutide NAME OF THE MEDICINE Victoza (liraglutide (rys)) solution for injection. Liraglutide (rys) has the molecular formula C 172 H 265 N

More information