A Glycemic Control Evaluation of Glimepiride Versus Rimonabant on Top of Metformin in Type 2 Diabetes
Information source: Sanofi-Aventis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetes Mellitus, Type 2
Intervention: rimonabant (SR141716) (Drug); glimepiride (Drug)
Phase: Phase 3
Status: Active, not recruiting
Sponsored by: Sanofi-Aventis Official(s) and/or principal investigator(s):
ICD, Study Director, Affiliation: Sanofi-Aventis
Summary
The primary objective is to demonstrate, after 52 weeks of treatment, the non-inferiority of
rimonabant 20 mg od versus glimepiride od in reducing HbA1c in overweight/obese patients with
type 2 diabetes not adequately controlled with metformin at a stable dose (≥ 1500 mg/day) for
at least 3 months.
The main secondary objectives are to assess the effect of rimonabant in comparison with
glimepiride on body weight and HDL-Cholesterol and the long-term safety and tolerability of
rimonabant in comparison with glimepiride.
Clinical Details
Official title: A Randomized, Double-Blind, Parallel-Group, Multicenter, Multinational Study to Assess Glycemic Control With Rimonabant in Comparison With Glimepiride Over 1 Year in Overweight/Obese Type2 Diabetic Patients Not Adequately Controlled With Metformin
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary outcome: Change from baseline in glycemic measure HbA1c
Secondary outcome: Absolute change from baseline in body weight and relative change from baseline in HDL-Cholesterol
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients with legal age
- Body Mass Index >27kg/m2
- Type 2 diabetes as defined by WHO criteria, treated with metformin for at least 6
months and with a stable dose of metformin >=1500 mg/day for at least three months
- HbA1c >=7% and <=9% at screening visit
Exclusion Criteria:
- Weight loss > 5 kg within three months prior to screening
- Presence of any clinically significant endocrine disease according to the
Investigator
- Presence of type 1 diabetes
- Presence or history of cancer within the past 5 years with the exception of
adequately-treated localized basal cell skin cancer or in situ uterine cervical
cancer
- Previous participation in a clinical study with rimonabant
- Absence of effective medical contraceptive method for females of childbearing
potential
- Within 3 months prior to screening visit: use of oral antidiabetic drugs (other than
metformin) and/or insulin, of anti-obesity drugs or other drugs for weight reduction
- Within 2 months prior to screening visit: administration of systemic long-acting
corticosteroids or prolonged use (more than one week) of other systemic
corticosteroids, change in lipid lowering treatment
The above information is not intended to contain all considerations relevant to a patient's
potential participation in a clinical trial.
Locations and Contacts
Sanofi-Aventis Administrative Office, Santiago, Chile
Sanofi-Aventis Administrative Office, Horsholm, Denmark
Sanofi-Aventis Administrative Office, Helsinki, Finland
Sanofi-Aventis Administrative Office, Budapest, Hungary
Sanofi-Aventis Administrative Office, Milan, Italy
Sanofi-Aventis Administrative Office, Seoul, Korea, Republic of
Sanofi-Aventis Administrative Office, Mexico, Mexico
Sanofi-Aventis Administrative Office, Puerto Rico, Puerto Rico
Sanofi-Aventis Administrative Office, Moscow, Russian Federation
Sanofi-Aventis Administrative Office, Barcelona, Spain
Sanofi-Aventis Administrative Office, Bromma, Sweden
Sanofi-Aventis Administrative Office, Bridgewater, New Jersey 08807, United States
Additional Information
Starting date: March 2007
Ending date: August 2009
Last updated: June 19, 2008
|
