Endocrine Update Mary T. Korytkowski MD Division of Endocrinology University of Pittsburgh

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1 Endocrine Update 2016 Mary T. Korytkowski MD Division of Endocrinology University of Pittsburgh

2 Disclosure of Financial Relationships Mary Korytkowski MD Honoraria British Medical Journal Diabetes Research and Care Other ABIM Endocrinology & Metabolism Test-Writing Committee NO exam content will be disclosed

3 Topics to Cover Endocrinology Testosterone therapy in older men Hormone replacement therapy in postmenopausal women Diabetes Changes in metformin labeling New information regarding Diabetes Technology New insulins: New concentrated insulins New long acting insulin

4 Male Reproduction

5 Male Reproduction Testosterone (T) Replacement Approved for low testosterone due to medical conditions in prescriptions from 1.3 million patients in 2009 to 2.3 million in 2013; use quadrupled from T levels decrease and SHBG levels increase with aging and obesity Proportion of men with T < 325 ng/dl increases with age 10% of men age ~ years 50% of men age 80 Testosterone therapy NOT approved for low T due to aging

6 Candidates for T Replacement Therapy Men with symptoms or conditions that suggest T deficiency Decreased libido, energy, or mood Low BMD osteoporosis Anemia And who have an at least 2 early AM (8-10A) measures of Total T < 300 ng/dl (10.4 nmol/l) x 3 Measurement by LC/MS/MS preferred over RIA Free or bioavailable T can be calculated from TT and SHBG

7

8 European Male Ageing Study Objective: To determine if men with a low serum testosterone due to age alone develop signs and symptoms of male hypogonadism. Subjects: 3369 men aged 40 to 79 Findings: The combination of low serum testosterone (<317 ng/dl [11 nmol/l]) and three sexual symptoms occurred in 2.1 % of men This was associated with lower hemoglobin, BMD, mid-upper arm circumference, and physical performance. More severe hypogonadism (T <230 ng/dl [8 nmol/l]) was associated with insulin resistance in addition to above symptoms These data support the concept of a low testosterone syndrome in a small percentage of middle aged and older men.

9 Risks and Benefits of Testosterone Replacement Benefits: (inconsistently demonstrated) Increase muscle mass Decrease fat mass Improved physical and sexual functioning Improved energy Risks Randomized trial of T Rx in older men with mobility limitations was stopped early because of increased adverse cardiovascular events in the T group Concerns raised by some studies that T may increase the risk of CV events Others: polycythemia, increase risk for prostate CA

10 Purpose: To determine potential benefits of raising T in older men. Design: Men age 65 with TT < 275 ng/dl and symptoms suggesting hypogonadism low libido, decreased morning erections, loss of body hair, low BMD, gynecomastia Each participated in one or more of 3 placebo-controlled trials (sexual function, physical function, vitality)

11 Study Population Placebo Testosterone Gel N Age 72.3 ± ±5.7 BMI (kg/m 2 ) 31 ± ± 3.5 Diabetes (%) HTN (%) History MI (%) Testosterone (ng/dl) 236 ± ± 63

12 Testosterone gel 5g per day T levels increased to mid-normal range for men x 1 yr N Engl J Med 2016;374:611-24

13 Male Reproduction Testosterone Replacement Results: Testosterone therapy associated with: sexual activity, sexual desire, erectile function 6-min walking distance with all 3 trials combined No change in vitality Better mood, lower severity of depressive symptoms

14 AE during the First Year of the Testosterone Trials Snyder PJ et al. N Engl J Med 2016;374:

15 Male Reproduction Testosterone Replacement Implications: Modest benefits in sexual function that waned in the latter part of the trial Small gains in physical performance, mood and depression No improvement in vitality Wide variability in response making it difficulty to predict who will benefit Not large enough to address risks Strict criteria advantages but limits generalizability e.g. How does this apply to younger men or men with higher testosterone levels?

16 In the absence of pituitary or testicular disease, consider TRT only if T consistently < 200 ng/dl (6.9 nmol/l), AND only after discussion with the patient of the potential benefits and risks.

17 Female Reproduction

18 Female Reproduction Estrogen Replacement Women spend 1/3 of their life in menopause 50 million by 2020 Women transitioning through the menopause report symptoms Hot flashes, sleep disturbances, mood changes, cognitive effects Economic implications Treatments available but few women are treated with ERT / HRT Impact of the WHI 2002 Very specific design, study population, and therapy Results being applied inappropriately Result: Women are using untested and unregulated alternatives

19 Purpose: To test the hypothesis that the cardiovascular effects of postmenopausal hormone therapy vary with the timing of therapy initiation Design: Oral estradiol (1 mg daily) or placebo (+/- vaginal progesterone) Early postmenopause (6 years) vs late postmenopause ( 10 years) x 5 years

20 Study Population Early Menopause Late Menopause Placebo Estradiol Placebo Estradiol N Median Age Median BMI (kg/m 2 ) 26 ( ) 26.2 (23-31) 26 ( (23-31) HTN (%) LDL (mg/dl)

21 CIMT Progression According to Study Group and Postmenopause Stratum Hodis HN et al. N Engl J Med 2016;374:

22 Female Reproduction Vascular Effects Results: Carotid-artery intima-media thickness (CIMT) measured every 6 months Greater Increase in placebo vs estradiol treated women initiating therapy < 6 years postmenopause No effect of treatment in women initiating therapy 10 years postmenopause Implications: Beneficial effects of estradiol treatment on progression of atherosclerosis are dependent on the timing of initiation of treatment Relevance to clinical coronary heart disease remains unknown does not reverse the stance on prevention

23 Metformin Labeling

24

25 Updated Metformin CKD Prescribing Guidelines (April 2016) Obtain egfr before starting metformin and annually, more frequently in those at risk for renal impairment (e.g., elderly). Metformin contraindicated in patients with an egfr <30. Starting metformin in patients with an egfr between not recommended. If egfr falls <45, assess the benefits and risks of continuing treatment. D/C if egfr falls <30. Hold metformin at the time of / before iodinated contrast procedure if egfr 30-60; if h/o liver disease, alcoholism, or heart failure; or if intra-arterial contrast. Recheck egfr 48 hrs after procedure and restart if renal function stable. (accessed )

26 Diabetes Technology

27 received J Clin Endocrinol Metab November 2016

28 The guideline task force: Gave its strongest recommendation in support of using CGM technology in individuals with T1D who are able and willing to use the monitors. Suggested that CGMs be used on a short-term, intermittent basis for individuals with T2D whose BG is > target. Recommended insulin pump therapy over MDI for T1D patients who have not met their A1C goals and are willing and able to use the device. If there is frequent hypoglycemia or glucose variability For those who require increased insulin delivery flexibility or improved satisfaction with their diabetes care. For T2D not at goal Recommends that all patients and healthcare providers be properly educated and trained to use the devices.

29 received

30 FDA approval for WORLD S FIRST HYBRID CLOSED LOOP SYSTEM FOR PEOPLE WITH TYPE 1 DIABETES HYBRID CLOSED LOOP SYSTEM COMPONENTS New closed-loop algorithm, pump platform and CGM display New Sensor and transmitter Sensors calibrated with branded blood glucose meter The sensor, transmitter, software, and insulin pump are currently limited to investigational use.

31 PIVOTAL TRIAL DATA HYBRID CLOSED LOOP SYSTEM ASSESSMENT OF DAILY GLYCEMIC VARIABILITY 1 All Patients Adult Patients Adolescent Patients Reduced glycemic variability (high and low glucose* events) 2 with Automated Basal Delivery in both adult and adolescent cohorts. Without Automated Basal Delivery With Automated Basal Delivery 33 Bergenstal R, et al. ADA 74th Scientific sessions June 10-14, 2016 JAMA

32 New Insulins U200 Lispro U300 glargine U100 and U200 degludec Peglylated lispro (not approved)

33 U100 U300 Concentrated Insulins U100 insulins Contain 1 unit of insulin for each 0.01 ml of insulin Regular U500 Contain 5 units in each 0.01 ml (1 unit mark on insulin syringe) Lispro U200 Contain 2 units in each 0.01 ml (1 unit mark on insulin syringe) Degludec U200 Contain 2 units in each 0.01 ml (1 unit mark on insulin syringe) Glargine U300 Contain 3 units in each 0.01 ml (1 unit mark on insulin syringe)

34 Concentrated Insulins All concentrate insulins (including U500) are available as insulin pens which decreases risk for error. Desired dose is dialed into the insulin pen

35 PK/PD Profiles of Glargine U100 vs. U300 Single dose euglycemic clamp study in T1DM 20 SC INJECTION U100 U300 GIR (mg.kg -1.min -1 ) INS (µu.ml -1 )* <LLOQ Time (hour) Tillner J et al. ADA June ; Chicago, IL, USA (Abstract 920-P)

36 Insulin Degludec: An Ultralong-Acting Basal Insulin U-100 Formulation U-200 Formulation U/kg 5 GIR, mg/kg/min U/kg 0.4 U/kg GIR, mg/kg/min U/kg Time, h Time, h GIR = glucose infusion rate Heise T, et al. Diabetes Obes Metab. 2012;14: Heise T, et al. Diabetes. 2012;61(suppl 1):A91 [abstract 349-OR].

37 Topics Covered The testosterone trial 2016 is the first study demonstrating benefit of hormone replacement therapy in men age 65 meeting established criteria for T replacement The ELITE Trial demonstrated improvement in surrogate markers of CVD with ERT and HRT in women with early but not late menopause Diabetes Metformin can be used safely and with FDA approval to an egfr of 45 ml/min with proper monitoring of renal function Continuous glucose monitoring devices are becoming standard of care for selected individuals with type 1 diabetes The Bionic Pancreas is becoming more of a reality with recent approval of the hybrid closed loop delivery system Diabetes Technology is expanding with potential to achieve near normal BG levels with use of New The introduction of new insulin products with different insulin concentrations expands the number of choices available for treating patients with insulin requiring diabetes.

38

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