Status:
COMPLETED
Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients
Lead Sponsor:
Sanofi
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary: Effect on HbA1c over 6 months in drug-naive patients with type 2 diabetes Secondary: Effect on glucose, insulin, C-peptide, insulin resistance, body weight, HDL-cholesterol, triglycerides, b...
Detailed Description
The total duration of the study will be up to 6 and 1/2 months including screening period (up to 14 days) and double-blind treatment period (approximately 6 months) in patients on mild hypocaloric die...
Eligibility Criteria
Inclusion
- Male or female patients aged greater than or equal to 18 years.
- Diagnosis of type 2 diabetes as defined by WHO criteria for at least 2 months but no longer than 3 years.
- Type 2 diabetes not previously treated by a pharmacological agent.
- Note:
- a) insulin use is accepted if it is not within 6 months prior to screening visit and only for the following reasons:
- prior use for management of gestational diabetes,
- short-term (less than or equal to 1 month) use to maintain glycemic control for hospitalization, medical procedures, or intervention.
- b) use of an oral antidiabetic agent is accepted if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
- HbA1C greater than or equal to 7% and less than or equal to 10%.
- Having signed the informed consent form.
Exclusion
- General:
- Weight loss \> 5 kg within 3 months prior to screening visit.
- Pregnancy or lactation.
- Absence of medically approved contraceptive methods for females of childbearing potential.
- Marijuana or hashish users.
- Administration of other investigational drugs within 30 days prior to screening visit.
- Previous participation in a rimonabant study.
- Presence or history of allergic reaction or intolerance to multiple drugs.
- Presence of any other condition (e.g., geographic, social) that the Investigator feels that would restrict or limit the patient's participation for the duration of the study.
- Related to endocrine and metabolic disorders:
- Presence of any clinically significant endocrine disease according to the Investigator.
- Note: euthyroid patients on replacement therapy will be included if the dosage of thyroxine is stable for at least 3 months prior to screening visit.
- Fasting C-peptide \< 1.0 ng/mL.
- Related to other disorders:
- Presence of any severe medical or psychological condition that in the opinion of the Investigator would compromise the patient's safety or successful participation in the study.
- Presence or history of cancer within the past five years with the exception of adequately treated localized basal cell skin cancer or in situ uterine cervical cancer.
- Related to laboratory findings:
- Positive test for hepatitis B surface antigen and/or hepatitis C antibody.
- Abnormal TSH level (TSH \> ULN or \< LLN).
- Hemoglobin \< 11 g/dL and/or neutrophils \< 1,500/mm3 and/or platelets \< 100,000/mm3.
- Positive urine pregnancy test.
- Positive urine test for marijuana or hashish metabolites.
- Related to previous or concomitant medications:
- Oral antidiabetic agent except if it is not within 6 months prior to screening visit and only if it was prescribed for no more than 4 months.
- Insulin except if it is not within 6 months prior to screening visit and only for management of gestational diabetes or short-term use to maintain glycemic control for hospitalization, medical procedures, or intervention.
- Drugs affecting weight (e.g., sibutramine, orlistat, herbal preparations, etc).
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2006
Estimated Enrollment :
281 Patients enrolled
Trial Details
Trial ID
NCT00257257
Start Date
March 1 2005
End Date
June 1 2006
Last Update
April 20 2009
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
3
Sanofi-Aventis Administrative Office
Santiago, Chile
4
Sanofi-Aventis Administrative Office
Berlin, Germany