Study Evaluating Rimonabant Efficacy in Drug-NAive DiabEtic Patients (SERENADE)

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00257257
First received: November 21, 2005
Last updated: April 17, 2009
Last verified: April 2009
  Purpose

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


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Rimonabant (SR141716)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Absolute change in HbA1C from baseline to Month 6.

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

Enrollment: 281
Study Start Date: March 2005
Study Completion Date: June 2006
Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
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 diet (600 kcal/day deficit).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00257257

Locations
United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Argentina
Sanofi-Aventis Administrative Office
Buenos Aires, Argentina
Chile
Sanofi-Aventis Administrative Office
Santiago, Chile
Germany
Sanofi-Aventis Administrative Office
Berlin, Germany
Hungary
Sanofi-Aventis Administrative Office
Budapest, Hungary
Netherlands
Sanofi-Aventis Administrative Office
Gouda, Netherlands
Poland
Sanofi-Aventis Administrative Office
Warszawa, Poland
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: NCT00257257     History of Changes
Other Study ID Numbers: EFC5825
Study First Received: November 21, 2005
Last Updated: April 17, 2009
Health Authority: United States: Food and Drug Administration
European Union: European Medicines Agency

Keywords provided by Sanofi:
Type 2 diabetes mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Rimonabant
Cannabinoid Receptor Antagonists
Cannabinoid Receptor Modulators
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 19, 2014