BMS-646256 in Obese and Overweight Type 2 Diabetics

Phase 2

Withdrawn

• Conditions: Obesity and Type 2 Diabetes
• Interventions: Drug: ibipinabant

• Registration Number: NCT00541567
• Lead Sponsor: Solvay Pharmaceuticals

Brief Summary

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%).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2007-10-09
• Study First Submitted QC: 2007-10-09
• Study First Posted: 2007-10-10
• Status Verified: 2008-01
• Last Update Submitted: 2008-01-08
• Last Update Posted: 2008-01-09
• Study Start: 2008-03
• Study Completion: 2010-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 600

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%).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	ibipinabant	-
2	ibipinabant	-
3	ibipinabant	-
4	ibipinabant	-

Primary Outcome Measures

Name	Time	Method
Absolute change from baseline in body weight (kg) and HbA1c (%)	26 weeks of double-blind therapy

Secondary Outcome Measures

Name	Time	Method
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