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

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00754689
First received: September 17, 2008
Last updated: November 7, 2008
Last verified: November 2008
  Purpose

The primary objective of the study is to demonstrate superiority of rimonabant/metformin combinations in 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 of the study is to investigate the effects of rimonabant/metformin combinations for reducing fasted plasma glucose, body weight and triglycerides, and raising HDL-C in comparison with metformin at 9 months.

Another study objective is to evaluate the safety of rimonabant in combination with metformin over a period of up to 52 weeks.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: rimonabant (SR141716)
Drug: metformin
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Double Blind, Placebo Controlled Randomized Study of the Efficacy and Safety of Two Rimonabant/Metformin Combinations for Reducing A1C in the Treatment of Patients With Type 2 Diabetes Mellitus Who Are Not on Current Drug Therapy.

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in A1C [ Time Frame: at 9 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Percent change from baseline in TG [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
  • Percent change from baseline in HDL-C [ Time Frame: at 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 750
Study Start Date: September 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1
metformin 500mg bid + placebo
Drug: metformin
oral administration
Drug: placebo
oral administration
Active Comparator: Arm 2
metformin 1000mg bid + placebo
Drug: metformin
oral administration
Drug: placebo
oral administration
Active Comparator: Arm 3
rimonabant 20mg od + placebo
Drug: rimonabant (SR141716)
oral administration
Experimental: Arm 4
rimonabant 10mg bid (from week 2) in combination with metformin 500mg bid
Drug: rimonabant (SR141716)
oral administration
Drug: metformin
oral administration
Experimental: Arm 5
rimonabant 10mg bid (from week 2) in combination with metformin 1000mg bid
Drug: rimonabant (SR141716)
oral administration
Drug: metformin
oral administration

Detailed Description:

The duration per patient is up to 65 weeks: 1 - 2 weeks screening, up to 52 weeks double blind treatment, and 75 days post last dose. This study will end for all patients when the last patient has been treated for at least 9 months.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754689

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Additional Information:
No publications provided

Responsible Party: ICD CSD, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00754689     History of Changes
Other Study ID Numbers: EFC10231, EudraCT 2008-002500-26
Study First Received: September 17, 2008
Last Updated: November 7, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Rimonabant/metformin combination

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Metformin
Rimonabant
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 25, 2014