Obesity and Type 2 Diabetes
Conditions
Keywords
Wheight management in T2D
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%).
Interventions
DRUGibipinabant
oral, tablet, once daily
Sponsors
Bristol-Myers Squibb
Solvay Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absolute change from baseline in body weight (kg) and HbA1c (%) | 26 weeks of double-blind therapy |
Secondary
| Measure | 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 |
Outcome results
None listed