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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
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE May 7, 2008
First Posted Date  ICMJE June 4, 2008
Last Update Posted Date May 18, 2016
Study Start Date  ICMJE May 2008
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
Change from baseline in HbA1c [ Time Frame: 36 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 18, 2016)
  • Change from baseline in fasting plasma glucose [ Time Frame: 36 weeks ]
  • Change from baseline in body weight [ Time Frame: 36 weeks ]
  • Percent change from baseline in HDL-C and Triglycerides [ Time Frame: 36 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2008)
  • Change from baseline in fasting plasma glucose [ Time Frame: 36 weeks ]
  • Change from baseline in body weight [ Time Frame: 36 weeks ]
  • Percent change from baseline for lipid parameters [ Time Frame: 36 weeks ]
  • Safety [ Time Frame: 47 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes
Official Title  ICMJE 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
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.

Detailed Description The total duration per patient will be approximately 49 weeks including a 36-week double-blind treatment period.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Drug: Rimonabant
    Tablet, oral administration
    Other Names:
    • SR141716
    • Acomplia
  • Drug: Placebo (for Rimonabant)
    Tablet, oral administration
  • Drug: Metformin
    Metformin continued at stable dose as background therapy
Study Arms  ICMJE
  • Experimental: Rimonabant
    Rimonabant 20 mg once daily on top of metformin
    Interventions:
    • Drug: Rimonabant
    • Drug: Metformin
  • Placebo Comparator: Placebo
    Placebo (for Rimonabant) once daily on top of metformin
    Interventions:
    • Drug: Placebo (for Rimonabant)
    • Drug: Metformin
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: June 12, 2009)
403
Original Estimated Enrollment  ICMJE
 (submitted: June 2, 2008)
360
Actual Study Completion Date  ICMJE February 2009
Actual Primary Completion Date February 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Indonesia,   Lithuania,   Malaysia,   Mexico,   Philippines,   Poland,   Romania,   Russian Federation,   Slovakia,   Taiwan,   Thailand,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00690456
Other Study ID Numbers  ICMJE EFC10518
2007-004833-40 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: ICD CSD Sanofi
PRS Account Sanofi
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP