Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes (TOCCATA)
This study has been terminated.
(Company decision taken in light of demands by certain national health authorities)
Sponsor:
Sanofi
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00690456
First received: May 7, 2008
Last updated: June 12, 2009
Last verified: June 2009
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: rimonabant (SR141716) Drug: placebo |
Phase 3 |
| 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 |
| 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 |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Change from baseline in HbA1c [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Change from baseline in fasting plasma glucose [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Change from baseline in body weight [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Percent change from baseline for lipid parameters [ Time Frame: 36 weeks ] [ Designated as safety issue: No ]
- Safety [ Time Frame: 47 weeks ] [ Designated as safety issue: Yes ]
| Enrollment: | 403 |
| Study Start Date: | May 2008 |
| Study Completion Date: | February 2009 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: rimonabant (SR141716)
added to metformin
|
| Placebo Comparator: 2 |
Drug: placebo
added to metformin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00690456
Locations
| United States, New Jersey | |
| Sanofi-Aventis Administrative Office | |
| Bridgewater, New Jersey, United States, 08807 | |
| Indonesia | |
| Sanofi-Aventis Administrative Office | |
| Jakarta, Indonesia | |
| Lithuania | |
| Sanofi-Aventis Administrative Office | |
| Vilnius, Lithuania | |
| Malaysia | |
| Sanofi-Aventis Administrative Office | |
| Kuala Lumpur, Malaysia | |
| Mexico | |
| Sanofi-Aventis Administrative Office | |
| Mexico, Mexico | |
| Philippines | |
| Sanofi-Aventis Administrative Office | |
| Makati City, Philippines | |
| Poland | |
| Sanofi-Aventis Administrative Office | |
| Warszawa, Poland | |
| Romania | |
| Sanofi-Aventis Administrative Office | |
| Bucuresti, Romania | |
| Russian Federation | |
| Sanofi-Aventis Administrative Office | |
| Moscow, Russian Federation | |
| Slovakia | |
| Sanofi-Aventis Administrative Office | |
| Brastislava, Slovakia | |
| Taiwan | |
| Sanofi-Aventis Administrative Office | |
| Taipei, Taiwan | |
| Thailand | |
| Sanofi-Aventis Administrative Office | |
| Bangkok, Thailand | |
| Ukraine | |
| Sanofi-Aventis Administrative Office | |
| Kiev, Ukraine | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | ICD CSD | Sanofi |
More Information
No publications provided
| Responsible Party: | ICD Study Director, Sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00690456 History of Changes |
| Other Study ID Numbers: | EFC10518, EudraCT 2007-004833-40 |
| Study First Received: | May 7, 2008 |
| Last Updated: | June 12, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Sanofi:
|
Randomized Controlled Trial Metformin |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013