Study of Rimonabant/Metformin Combinations to Investigate Diabetes (Blood Sugar) Control in Patients With Type 2 Diabetes

NCT00754689 | Withdrawn Phase 3 DMC

• 2 other identifiers: EFC102312008-002500-26
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in Glycosylated Hemoglobin 1c (A1C) reduction over the corresponding single agent metformin and over rimonabant alone in patients with type 2 diabetes mellitus at 9 months. The secondary objective is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising High Density Lipoprotein Cholesterol (HDL-C) in comparison with metformin at 9 months. Another objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.

Conditions

Diabetes Mellitus, Type 2

Keywords

Rimonabant/metformin combination

Outcome Measures

Primary Outcomes (1)

• Change from baseline in A1C

  at 9 months

Secondary Outcomes (4)

• Change from baseline in fasting plasma glucose

  at 9 months

• Change from baseline in body weight

  at 9 months

• Percent change from baseline in triglycerides

  at 9 months

• Percent change from baseline in HDL-C

  at 9 months

Study Arms (5)

Arm 1

ACTIVE COMPARATOR

Metformin 500mg twice daily (bid) + placebo

Drug: Metformin; Drug: placebo

Arm 2

ACTIVE COMPARATOR

Metformin 1000mg bid + placebo

Drug: Metformin; Drug: placebo

Arm 3

ACTIVE COMPARATOR

Rimonabant 20mg once daily (od) + placebo

Drug: Rimonabant; Drug: placebo

Arm 4

EXPERIMENTAL

Rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid

Drug: Rimonabant; Drug: Metformin

Arm 5

EXPERIMENTAL

Rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid

Drug: Rimonabant; Drug: Metformin

Interventions

Rimonabant DRUG

Tablet, oral administration

Also known as: SR141716, Acomplia

Arm 3; Arm 4; Arm 5

Metformin DRUG

Tablet, oral administration

Arm 1; Arm 2; Arm 4; Arm 5

placebo DRUG

Tablet, oral administration

Arm 1; Arm 2; Arm 3

Eligibility Criteria

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

You may qualify if:

• History of type 2 diabetes mellitus diagnosed prior to the screening visit 1 (ADA criteria)
• Patients must not have used any oral or injectable glucose lowering medication at least 12 weeks prior to the screening visit to establish a stable, comparable baseline A1C assessment in all patients
• A1C ≥7.0 % and ≤10.0 %
• Fasted plasma glucose at screening visit ≤260 mg/dL (14.44 mmol/L)

You may not qualify if:

• Treatment with any anti-diabetic oral agent, or injectable antidiabetic agent within 12 weeks prior to screening visit
• In the 3 months prior to the screening visit, use of any anti-obesity agent or drugs for weight loss, or administration of systemic corticosteroids for more than 7 days
• Presence of any severe medical or psychological condition that, in the opinion of the investigator, would compromise the patient's safe participation including uncontrolled serious psychiatric illness such a major depression within the last 2 years, and history of other severe psychiatric disorders
• Presence or history of cancer within the past five years
• Pregnant or breast-feeding women, or women of childbearing potential not protected by effective method of birth control
• The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (1)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Rimonabant; Metformin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperidines; Biguanides; Guanidines; Amidines; Organic Chemicals

Study Officials

• ICD CSD

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2008
• First Posted: September 18, 2008
• Study Start: September 1, 2008
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: May 17, 2016

Record last verified: 2016-05

Locations

US (1)