BMS-646256 in Obese and Overweight Type 2 Diabetics

Study Overview
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Brief Summary
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This is a placebo-controlled, randomized, double-blind, parallel arm, multicenter, dose-ranging phase IIb trial to assess glycemic and weight loss efficacy and safety of BMS-646256 in overweight and obese patients with type 2 diabetes who have been treated with diet and exercise only or with half-maximal or greater metformin (≥1500mg/day) or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c >7% and HbA1c<10%).

Official Title
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A Placebo-Controlled, Randomized, Double-Blind, Parallel Arm, Multicenter, Dose-Ranging Phase IIb Trial to Assess Glycemic and Weight Loss Efficacy and Safety of BMS-646256 in Overweight and Obese Patients With Type 2 Diabetes Inadequately Controlled by Diet and Exercise Only or With Metformin or Sulfonylurea Monotherapy

Conditions
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Obesity and Type 2 Diabetes

Intervention / Treatment
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* Drug: ibipinabant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 18-70 years and BMI ≥27 with type 2 diabetes who have been treated with diet and exercise only or with half maximal or greater metformin or sulfonylurea monotherapy (stable dose for at least three months), but who remained inadequately controlled (HbA1c >7% and HbA1c<10%). Exclusion Criteria: Pregnancy Anti-diabetic medications other than baseline metformin or sulfonylurea monotherapy History of myocardial infarction in the prior six months/ History of heart failure defined as New York Heart Association Functional Class I, II, III or IV/ History of symptomatic arrhythmia Active hepatic disease/ Any documented muscle disease History of multiple sclerosis/ Baseline history of tremors, ataxia, anxiety or dizziness Seizures within the last year, stroke, and transient ischemic attack/ Known history of schizophrenia, dementia, or bipolar disorder as defined by DSM IV criteria. Currently depressed subjects or a CES-D score greater or equal to 16 at the screening visit or at baseline (Day 1)/ History of suicide attempt or ideation Previous history of surgical procedures for weight loss (e.g. stomach stapling, bypass)/ Weight loss greater than 5 kg in the prior 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br> | Drug: ibipinabant<br>* oral, tablet, once daily<br>|
| Experimental: 2<br> | Drug: ibipinabant<br>* oral, tablet, once daily<br>|
| Experimental: 3<br> | Drug: ibipinabant<br>* oral, tablet, once daily<br>|
| Experimental: 4<br> | Drug: ibipinabant<br>* oral, tablet, once daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change from baseline in body weight (kg) and HbA1c (%) |  | 26 weeks of double-blind therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Waist circumference, fasting glucose and insulin, HOMA analysis, blood lipids (triglycerides, total cholesterol, HDL-C, LDL-C, ApoB) and systolic/ diastolic blood pressure |  | 52 weeks treatment followed by 20 weeks off-medication period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wheight management in T2D