Journal Club September 29, Vanessa AKIKI PGYlII Internal Medicine

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1 Journal Club September 29, 2017 Vanessa AKIKI PGYlII Internal Medicine AUBMC 2017

2 Case Presentation 41-year-old man who was diagnosed with type 1 diabetes 21 years ago presents to your clinic. He believes that his diabetes has been fairly well controlled during the past 20 years and that his insulin needs have been the same for the last year. He would like help in losing 10 lb. His body mass index is 25 kg/m2. His medications include pravastatin (Pravacol), 10 mg daily; Amlodipine 10 mg daily, NPH insulin, 34 units in the morning and 13 units at bedtime; and regular insulin at breakfast and dinner following a sliding-scale algorithm. He also takes lispro (Humalog) insulin as needed to correct high blood glucose. He is not checking his blood glucose on a regular basis. No hypoglycemic episodes, no Recent DKA within the last years.

3 Case Presentation ROS: otherwise negative Allergies :NKDA PMH: DM type 1, DLP, HTN PSH: Negative FHx : DM type 1 brother Social: smoking-, EtOH Lab Tests: A1C: 8.3% (normal %) Creatinine: 0.9 mg/dl (normal: mg/dl) Microalbumin: 4 g (normal: 0 29 g) You tell him: Please come back with dextro charting and I would like to increase your insulin doses to achieve an Hba1c of less than 7.

4 Case Presentation Dr.,Can you add a pill that helps me control my sugar level instead of increasing my insulin dose?..as you know Dr.,I am trying to loose weight and more insulin would make this task more difficult

5 PICO Patient : Patient with DM 1 Intervention : Add sotagliflozin to insulin Comparison : Placebo + insulin Outcome : HbA1c < 7.0% at week 24, with no episodes of severe hypoglycemia or diabetic ketoacidosis

6

7 InTandem3 Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin TherapyAlone (intandem3) Results were presented September 13 at the European Association for the Study of Diabetes (EASD) 2017 Annual Meeting. They were simultaneously published in the New England Journal of Medicine.

8 InTandem3 : Sotagliflozin SGLT1 and SGLT2 inhibitor

9 Patient Population Men and nonpregnant women : > 18 years of age type 1 diabetes for at least 1 year Treatment with insulin at a stable basal dose for at least 2 weeks before the screening visit HbA1c : 7.0 to 11.0% BMI > 18.5

10 Exclusion Criteria Severe hypoglycemia during the previous month Diabetic ketoacidosis during the previous month 2 or more episodes of diabetic ketoacidosis during the previous 6 months GFR <45 ml per minute per 1.73 m2 of body-surface area.

11 Design From October 2015 through September 2016 multicenter, randomized, double-blind, placebo-controlled trial Conducted at 133 sites in 19 countries patients were randomly assigned, in a 1:1 ratio, to receive either sotagliflozin (400 mg per day) or placebo for 24 weeks Modified intentionto-treat 1405 patients underwent randomization 1402 patients were included 699 patients in the sotagliflizin group 703 patients in the placebo group

12 End Points Primary outcomes HBa1c < 7.0% at week 24 with no episodes of severe hypoglycemia or diabetic ketoacidosis Secondary outcomes the change from baseline to week 24 in: glycated hemoglobin level body weight mean daily bolus dose of insulin systolic blood pressure

13 Statistical Analysis 700 patients per trial group >90% power, effect size 0.10 assuming that 50% of the participants overall would achieve the primary end point the null hypothesis of no treatment effect was tested at a two-sided alpha level of Categorical variables were analyzed as proportions Safety analyses were descriptive.

14 RCT Critical Appraisal 1- Internal Validity 2- Results 3- External Validity / Applicability

15 RCT Appraisal: Internal Validity Was the assignment of patients to treatments randomised? YES eligible patients were randomly assigned, in a 1:1 ratio, to receive either sotagliflozin (400 mg per day) or placebo for 24 weeks. Was randomization concealed? YES

16 RCT Appraisal: Internal Validity Were all patients analyzed in the groups to which they were randomized? NO 1405 patients underwent randomization,1402 patients were included in the modified intention-to-treat population Were Patients in the treatment and control groups similar with respect to known prognostic variables? YES

17

18 RCT Appraisal: Internal Validity Were the patients and clinicians kept blind to which treatment was being received? YES In the sotagliflozin group, patients received the 400-mg dose of sotagliflozin as two 200-mg oral tablets.in the placebo group, patients took two matching placebo tablets in the same manner Independent clinical end-point committee, whose members were unaware of the treatment assignments, adjudicated events of special interest Was follow up complete? YES Efficacy and safety were assessed at prespecified times during the treatment period, and a final safety assessment was performed 30 days after the last dose of the trial regimen was administered.

19 Results What are the results? How large was the treatment effect? How precise was the estimate of the treatment effect?

20 Results

21 Results outcome No outcome Total Sotagliflozin Placebo ARR = EER-CER = 200/ /703 = 13.4 NNT = 1/ARR= 7.8 RRR= EER-CER/CER = 0.88 = 88 %

22 Results

23 Results In the Sotagliflozin group : The reduction in body weight : significantly greater (difference, 2.98 kg; P<0.001). reductions from baseline in the mean daily total, bolus, and basal doses of insulin were 5.3 units per day ( 9.7%), 2.8 units per day ( 12.3%), and 2.6 units per day ( 9.9%), respectively (P<0.001 for all comparisons). reduction in systolic blood pressure from baseline was greater (difference, 3.5 mm Hg; P = 0.002) BUT

24 Results

25 Results

26 LIMITATIONS Longterm effects of sotagliflozin cannot be determined from this 24-week trial. glycated hemoglobin levels were masked to investigators after screening if investigators had had access to the data, they may have adjusted insulin therapy more aggressively to meet target. measures to mitigate the risk of diabetic ketoacidosis that may have been more intensive than those used in typical clinical practice. Data from continuous glucose monitoring were not analyzed in this trial. No artificial pancreas system had been approved at the time of trial initiation.

27 RCT Appraisal: External Validity / Applicability 3.How can I apply the results to patient care? Were the study patients similar to my patient? > 18 yo type 1 diabetes for at least 1 year Treatment with insulin at a stable basal dose for at least 2 weeks before the screening visit HbA1c : 7.0 to 11.0% BMI > 18.5

28 RCT Appraisal: External Validity / Applicability Were all clinically important outcomes considered? YES Are the likely treatment benefits worth the potential harm and costs? NO Harms : diabetic ketoacidosis severe hypoglycemia > sotagliflozin Costs:

29 RCT Appraisal: External Validity / Applicability

30 Thank You for your Attention!

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