Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients

Completed · Phase 3

Conditions studied: Type 2 Diabetes Mellitus

In brief

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, blood pressure - Safety, tolerability

Key facts

Study ID

NCT00257257

Run by

Sanofi

People needed

281

Starts

2005-03-01

Expected to finish

2006-06-01

Last updated by the study team

2009-04-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
• Sanofi-Aventis Administrative Office — Buenos Aires, Argentina
• Sanofi-Aventis Administrative Office — Santiago, Chile
• Sanofi-Aventis Administrative Office — Berlin, Germany
• Sanofi-Aventis Administrative Office — Budapest, Hungary
• Sanofi-Aventis Administrative Office — Gouda, Netherlands
• Sanofi-Aventis Administrative Office — Warsaw, Poland

Full record on ClinicalTrials.gov

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