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BMS-646256 in Obese and Overweight Type 2 Diabetics

Primary Purpose

Obesity and Type 2 Diabetes

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

ibipinabant

About this trial

This is an interventional treatment trial for Obesity and Type 2 Diabetes focused on measuring Wheight management in T2D

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Arm Description

Outcomes

Primary Outcome Measures

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

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

Full Information

NCT ID

NCT00541567

First Posted

October 9, 2007

Last Updated

January 8, 2008

Sponsor

Solvay Pharmaceuticals

Collaborators

Bristol-Myers Squibb

1. Study Identification

Unique Protocol Identification Number

NCT00541567

Brief Title

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

2. Study Status

Record Verification Date

January 2008

Overall Recruitment Status

Withdrawn

Study Start Date

March 2008 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Solvay Pharmaceuticals

Collaborators

Bristol-Myers Squibb

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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%).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity and Type 2 Diabetes

Keywords

Wheight management in T2D

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Placebo Comparator

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Arm Title

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

ibipinabant

Intervention Description

oral, tablet, once daily

Primary Outcome Measure Information:

Title

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

Time Frame

26 weeks of double-blind therapy

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Global Clinical Director Solvay

Organizational Affiliation

Solvay Pharmaceuticals

Official's Role

Study Director

12. IPD Sharing Statement

Learn more about this trial

BMS-646256 in Obese and Overweight Type 2 Diabetics

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