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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rimonabant
Placebo (for Rimonabant)
Metformin
Sponsored by
Sanofi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring Randomized Controlled Trial, Metformin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office
  • Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rimonabant

Placebo

Arm Description

Rimonabant 20 mg once daily on top of metformin

Placebo (for Rimonabant) once daily on top of metformin

Outcomes

Primary Outcome Measures

Change from baseline in HbA1c

Secondary Outcome Measures

Change from baseline in fasting plasma glucose
Change from baseline in body weight
Percent change from baseline in HDL-C and Triglycerides

Full Information

First Posted
May 7, 2008
Last Updated
April 18, 2016
Sponsor
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT00690456
Brief Title
Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes
Acronym
TOCCATA
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 Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Terminated
Why Stopped
Company decision taken in light of demands by certain national health authorities
Study Start Date
May 2008 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanofi

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
Randomized Controlled Trial, Metformin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
403 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rimonabant
Arm Type
Experimental
Arm Description
Rimonabant 20 mg once daily on top of metformin
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo (for Rimonabant) once daily on top of metformin
Intervention Type
Drug
Intervention Name(s)
Rimonabant
Other Intervention Name(s)
SR141716, Acomplia
Intervention Description
Tablet, oral administration
Intervention Type
Drug
Intervention Name(s)
Placebo (for Rimonabant)
Intervention Description
Tablet, oral administration
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin continued at stable dose as background therapy
Primary Outcome Measure Information:
Title
Change from baseline in HbA1c
Time Frame
36 weeks
Secondary Outcome Measure Information:
Title
Change from baseline in fasting plasma glucose
Time Frame
36 weeks
Title
Change from baseline in body weight
Time Frame
36 weeks
Title
Percent change from baseline in HDL-C and Triglycerides
Time Frame
36 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ICD CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis Administrative Office
City
Bridgewater
State/Province
New Jersey
ZIP/Postal Code
08807
Country
United States
Facility Name
Sanofi-Aventis Administrative Office
City
Jakarta
Country
Indonesia
Facility Name
Sanofi-Aventis Administrative Office
City
Vilnius
Country
Lithuania
Facility Name
Sanofi-Aventis Administrative Office
City
Kuala Lumpur
Country
Malaysia
Facility Name
Sanofi-Aventis Administrative Office
City
Mexico
Country
Mexico
Facility Name
Sanofi-Aventis Administrative Office
City
Makati City
Country
Philippines
Facility Name
Sanofi-Aventis Administrative Office
City
Warszawa
Country
Poland
Facility Name
Sanofi-Aventis Administrative Office
City
Bucuresti
Country
Romania
Facility Name
Sanofi-Aventis Administrative Office
City
Moscow
Country
Russian Federation
Facility Name
Sanofi-Aventis Administrative Office
City
Brastislava
Country
Slovakia
Facility Name
Sanofi-Aventis Administrative Office
City
Taipei
Country
Taiwan
Facility Name
Sanofi-Aventis Administrative Office
City
Bangkok
Country
Thailand
Facility Name
Sanofi-Aventis Administrative Office
City
Kiev
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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