Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes (TOCCATA)

This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00690456
First received: May 7, 2008
Last updated: April 18, 2016
Last verified: April 2016
  Purpose

The primary objective of the study is to determine the effect of rimonabant 20 mg daily when added to ongoing metformin therapy on glycemic control (HbA1c) over a 36 week period in patients with type 2 diabetes.

Secondary objectives include evaluation of other markers of glycemic control, lipid profile, body weight, and abdominal obesity. Also, the trial will study the safety of rimonabant when added to metformin over a period of 47 weeks.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: Rimonabant
Drug: Placebo (for Rimonabant)
Drug: Metformin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Double Blind, Placebo Controlled Study Evaluating the Glycemic Effect of Rimonabant Added to Metformin in Patients With Type 2 Diabetes Insufficiently Controlled With Metformin Monotherapy

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Change from baseline in HbA1c [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in fasting plasma glucose [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in body weight [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
  • Percent change from baseline in HDL-C and Triglycerides [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 403
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rimonabant
Rimonabant 20 mg once daily on top of metformin
Drug: Rimonabant
Tablet, oral administration
Other Names:
  • SR141716
  • Acomplia
Drug: Metformin
Metformin continued at stable dose as background therapy
Placebo Comparator: Placebo
Placebo (for Rimonabant) once daily on top of metformin
Drug: Placebo (for Rimonabant)
Tablet, oral administration
Drug: Metformin
Metformin continued at stable dose as background therapy

Detailed Description:
The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • History of type 2 diabetes
  • HbA1c between 7% to 10% at screening visit
  • Treatment with metformin only with a fixed and stable dose of 1500 mg/day or more for at least the past 3 months prior to screening visit

Exclusion Criteria:

  • Within 3 months prior to screening visit: change in lipid modifying agent, administration of systemic corticosteroids for more than 10 days, use of any anti-obesity agent or drugs for weight loss
  • Weight loss of more than 5 kg within 3 months prior to screening
  • Administration of other investigational drugs within 30 days prior to screening visit
  • Prior exposure to type 1 cannabinoid receptor (CB1) antagonists including rimonabant
  • Presence or history of cancer within the past five years
  • Pregnant or breast-feeding women
  • 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.

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: NCT00690456

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Indonesia
Sanofi-Aventis Administrative Office
Jakarta, Indonesia
Lithuania
Sanofi-Aventis Administrative Office
Vilnius, Lithuania
Malaysia
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Mexico
Sanofi-Aventis Administrative Office
Mexico, Mexico
Philippines
Sanofi-Aventis Administrative Office
Makati City, Philippines
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
Romania
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Slovakia
Sanofi-Aventis Administrative Office
Brastislava, Slovakia
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Thailand
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Ukraine
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Sponsors and Collaborators
Sanofi
Investigators
Study Director: ICD CSD Sanofi
  More Information

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00690456     History of Changes
Other Study ID Numbers: EFC10518  2007-004833-40 
Study First Received: May 7, 2008
Last Updated: April 18, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Sanofi:
Randomized Controlled Trial
Metformin

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
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 July 28, 2016