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

Sponsor

Sanofi (Industry)

Overall Status

Terminated

CT.gov ID

NCT00690456

Collaborator

(none)

403

Enrollment

Locations

Arms

9.1

Duration (Months)

Patients Per Site

3.4

Patients Per Site Per Month

Study Details

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.

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.

Study Design

Study Type:

Interventional

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 1, 2008

Actual Primary Completion Date :

Feb 1, 2009

Actual Study Completion Date :

Feb 1, 2009

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from baseline in HbA1c [36 weeks]

Secondary Outcome Measures

Change from baseline in fasting plasma glucose [36 weeks]
Change from baseline in body weight [36 weeks]
Percent change from baseline in HDL-C and Triglycerides [36 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey	United States	08807
2	Sanofi-Aventis Administrative Office	Jakarta		Indonesia
3	Sanofi-Aventis Administrative Office	Vilnius		Lithuania
4	Sanofi-Aventis Administrative Office	Kuala Lumpur		Malaysia
5	Sanofi-Aventis Administrative Office	Mexico		Mexico
6	Sanofi-Aventis Administrative Office	Makati City		Philippines
7	Sanofi-Aventis Administrative Office	Warszawa		Poland
8	Sanofi-Aventis Administrative Office	Bucuresti		Romania
9	Sanofi-Aventis Administrative Office	Moscow		Russian Federation
10	Sanofi-Aventis Administrative Office	Brastislava		Slovakia
11	Sanofi-Aventis Administrative Office	Taipei		Taiwan
12	Sanofi-Aventis Administrative Office	Bangkok		Thailand
13	Sanofi-Aventis Administrative Office	Kiev		Ukraine