Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00257257
• Date of registration: 21/11/2005
• Prospective Registration: No
• Primary sponsor: Sanofi
• Public title: Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients SERENADE
• Scientific title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose (Rimonabant 20 mg) Multicenter Study of Long-Term Glycemic Control With Rimonabant in Treatment-naïve Patients With Type 2 Diabetes
• Date of first enrolment: March 2005
• Target sample size: 281
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00257257
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Argentina, Chile, Germany, Hungary, Netherlands, Poland, United States

Contacts

• Name: ICD CSD
• Affiliation: Sanofi

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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 Criteria:

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).



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

Health Condition(s) or Problem(s) studied

Type 2 Diabetes Mellitus

Intervention(s)

Drug: Rimonabant (SR141716)

Primary Outcome(s)

Absolute change in HbA1C from baseline to Month 6.

Secondary Outcome(s)

Fasting glucose, fasting insulin, C-peptide, HOMA analysis, body weight, HDL-cholesterol, triglycerides, blood pressure, safety (physical examination, vital signs, laboratory tests, adverse events).

Secondary ID(s)

EFC5825

Source(s) of Monetary Support

Please refer to primary and secondary sponsors