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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00690456
• Date of registration: 07/05/2008
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes TOCCATA
• Scientific 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
• Date of first enrolment: May 2008
• Target sample size: 403
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00690456
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

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

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion 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 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Type 2

Intervention(s)

Drug: placebo

Drug: rimonabant (SR141716)

Primary Outcome(s)

Change from baseline in HbA1c [Time Frame: 36 weeks]

Secondary Outcome(s)

Percent change from baseline for lipid parameters [Time Frame: 36 weeks]

Change from baseline in fasting plasma glucose [Time Frame: 36 weeks]

Safety [Time Frame: 47 weeks]

Change from baseline in body weight [Time Frame: 36 weeks]

Secondary ID(s)

EFC10518

EudraCT 2007-004833-40

Source(s) of Monetary Support

Please refer to primary and secondary sponsors