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

Diabetes Mellitus, Type 2 Clinical Trial

— 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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00690456
• Other study ID #: EFC10518
• Secondary ID: EudraCT 2007-004
• Status: Terminated
• Phase: Phase 3
• First received: May 7, 2008
• Last updated: June 12, 2009
• Start date: May 2008
• Est. completion date: February 2009

Study information

• Verified date: June 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 403
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• rimonabant (SR141716)
added to metformin
• placebo
added to metformin

Locations

Country	Name	City	State
Indonesia	Sanofi-Aventis Administrative Office	Jakarta
Lithuania	Sanofi-Aventis Administrative Office	Vilnius
Malaysia	Sanofi-Aventis Administrative Office	Kuala Lumpur
Mexico	Sanofi-Aventis Administrative Office	Mexico
Philippines	Sanofi-Aventis Administrative Office	Makati City
Poland	Sanofi-Aventis Administrative Office	Warszawa
Romania	Sanofi-Aventis Administrative Office	Bucuresti
Russian Federation	Sanofi-Aventis Administrative Office	Moscow
Slovakia	Sanofi-Aventis Administrative Office	Brastislava
Taiwan	Sanofi-Aventis Administrative Office	Taipei
Thailand	Sanofi-Aventis Administrative Office	Bangkok
Ukraine	Sanofi-Aventis Administrative Office	Kiev
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Indonesia,  Lithuania,  Malaysia,  Mexico,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  Taiwan,  Thailand,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in HbA1c		36 weeks	No
Secondary	Change from baseline in fasting plasma glucose		36 weeks	No
Secondary	Change from baseline in body weight		36 weeks	No
Secondary	Percent change from baseline for lipid parameters		36 weeks	No
Secondary	Safety		47 weeks	Yes