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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00690456
Recruitment Status : Terminated (Company decision taken in light of demands by certain national health authorities)
First Posted : June 4, 2008
Last Update Posted : May 18, 2016
Information provided by (Responsible Party):

Brief Summary:

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 or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: Rimonabant Drug: Placebo (for Rimonabant) Drug: Metformin Phase 3

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 403 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2008
Actual Primary Completion Date : February 2009
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Change from baseline in HbA1c [ Time Frame: 36 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in fasting plasma glucose [ Time Frame: 36 weeks ]
  2. Change from baseline in body weight [ Time Frame: 36 weeks ]
  3. Percent change from baseline in HDL-C and Triglycerides [ Time Frame: 36 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00690456

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Jakarta, Indonesia
Sanofi-Aventis Administrative Office
Vilnius, Lithuania
Sanofi-Aventis Administrative Office
Kuala Lumpur, Malaysia
Sanofi-Aventis Administrative Office
Mexico, Mexico
Sanofi-Aventis Administrative Office
Makati City, Philippines
Sanofi-Aventis Administrative Office
Warszawa, Poland
Sanofi-Aventis Administrative Office
Bucuresti, Romania
Russian Federation
Sanofi-Aventis Administrative Office
Moscow, Russian Federation
Sanofi-Aventis Administrative Office
Brastislava, Slovakia
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Sanofi-Aventis Administrative Office
Kiev, Ukraine
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi
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Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT00690456    
Other Study ID Numbers: EFC10518
2007-004833-40 ( EudraCT Number )
First Posted: June 4, 2008    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
Randomized Controlled Trial
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Anti-Obesity Agents
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Hormones, Hormone Substitutes, and Hormone Antagonists