Clinical trial NCT00541567: BMS-646256 in Obese and Overweight Type 2 Diabetics
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: Obesity and Type 2 Diabetes
Keywords: Wheight management in T2D
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Bristol-Myers Squibb
First posted: 2007-10-10
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%).


Eligibility criteria: 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

Primary outcomes:
measure: Absolute change from baseline in body weight (kg) and HbA1c (%)
timeFrame: 26 weeks of double-blind therapy
Secondary outcomes:
measure: Waist circumference, fasting glucose and insulin, HOMA analysis, blood lipids (triglycerides, total cholesterol, HDL-C, LDL-C, ApoB) and systolic/ diastolic blood pressure
timeFrame: 52 weeks treatment followed by 20 weeks off-medication period
Other outcomes:
Locations:
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: