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BMS-646256 in Obese and Overweight Type 2 Diabetics

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
Solvay Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00541567
First received: October 9, 2007
Last updated: January 8, 2008
Last verified: January 2008
History of Changes
  Purpose

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%).


Condition Intervention Phase
Obesity and Type 2 Diabetes
 Drug: ibipinabant
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Solvay Pharmaceuticals:

Primary Outcome Measures:
  • Absolute change from baseline in body weight (kg) and HbA1c (%) [ Time Frame: 26 weeks of double-blind therapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Waist circumference, fasting glucose and insulin, HOMA analysis, blood lipids (triglycerides, total cholesterol, HDL-C, LDL-C, ApoB) and systolic/ diastolic blood pressure [ Time Frame: 52 weeks treatment followed by 20 weeks off-medication period ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: March 2008
Estimated Study Completion Date: June 2010
Arms Assigned Interventions
Placebo Comparator: 1 Drug: ibipinabant
oral, tablet, once daily
Experimental: 2 Drug: ibipinabant
oral, tablet, once daily
Experimental: 3 Drug: ibipinabant
oral, tablet, once daily
Experimental: 4 Drug: ibipinabant
oral, tablet, once daily

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00541567

Sponsors and Collaborators
Solvay Pharmaceuticals
Bristol-Myers Squibb
Investigators
Study Director: Global Clinical Director Solvay Solvay Pharmaceuticals
  More Information

No publications provided

Responsible Party: Veronika von Hahn, Solvay Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00541567     History of Changes
Other Study ID Numbers: S319.2.002, EudraCT No. 2007-005124-32
Study First Received: October 9, 2007
Last Updated: January 8, 2008
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Solvay Pharmaceuticals:
Wheight management in T2D

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Overweight
Glucose Metabolism Disorders
Metabolic Diseases
 Endocrine System Diseases
Overnutrition
Nutrition Disorders
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 23, 2013