BMS-646256 in Obese and Overweight Type 2 Diabetics

NCT00541567 | Withdrawn Phase 2 DMC

• 2 other identifiers: S319.2.002EudraCT No. 2007-005124-32
• Study Type: interventional
• Target: 600
• Locations: 0 countries
• Sites: N/A

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%).

Conditions

Obesity and Type 2 Diabetes

Keywords

Wheight management in T2D

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in body weight (kg) and HbA1c (%)

  26 weeks of double-blind therapy

Secondary Outcomes (1)

• 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

Study Arms (4)

1

PLACEBO COMPARATOR

Drug: ibipinabant

2

EXPERIMENTAL

Drug: ibipinabant

3

EXPERIMENTAL

Drug: ibipinabant

4

EXPERIMENTAL

Drug: ibipinabant

Interventions

ibipinabant DRUG

oral, tablet, once daily

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%).

You may not qualify if:

• 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

Sponsors & Collaborators

• Solvay Pharmaceuticals: lead
• Bristol-Myers Squibb: collaborator

MeSH Terms

Conditions

Obesity; Diabetes Mellitus, Type 2

Interventions

ibipinabant

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases

Study Officials

• Global Clinical Director Solvay

  Solvay Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 9, 2007
• First Posted: October 10, 2007
• Study Start: March 1, 2008
• Study Completion: June 1, 2010
• Last Updated: January 9, 2008

Record last verified: 2008-01