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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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CTRI |
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Last refreshed on:
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4 May 2013 |
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Main ID: |
CTRI/2008/091/000040 |
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Date of registration:
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24-04-2008 |
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Primary sponsor: |
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Public title:
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A Glycemic Control Evaluation of Glimepiride versus Rimonabant on Top of Metformin in Type 2 Diabetes
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Scientific title:
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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 Type 2 Diabetic Patients Not Adequately Controlled with Metformin
- ALLEGRO |
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Date of first enrolment:
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30-03-2007 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=82 |
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Study type:
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Interventional |
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Study design:
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Randomized, Parallel Group, Active Controlled Trial
Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
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Countries of recruitment
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Democratic People's Republic of Korea
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India
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Contacts
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Name:
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Dr Chirag Trivedi
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Address:
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Sanofi-Synthelabo(India)Ltd A-101, Sir Mathuradas Vasanji Road, Andheri East
400 093
Mumbai, MAHARASHTRA
India |
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Telephone:
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02230707821 |
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Email:
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chirag.trivedi@sanofi.com |
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Affiliation:
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Sanofi-Synthelabo (India) Limited |
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Name:
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Dr Chirag Trivedi
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Address:
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Sanofi-Synthelabo(India)Ltd A-101, Sir Mathuradas Vasanji Road, Chakala, Andheri East
400 093
Mumbai, MAHARASHTRA
India |
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Telephone:
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02230707821 |
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Email:
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chirag.trivedi@sanofi.com |
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Affiliation:
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Sanofi-Synthelabo (India) Limited |
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Key inclusion & exclusion criteria
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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
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
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Type 2 Diabetes
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Intervention(s)
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Intervention1: Rimonabant: 20mg / day for 52 weeks
Control Intervention1: Glimepiride: Dose adjustment for initial 12 weeks with 1mg , 2mg & 4mg Glimepiride. Thereafter maintenance period with adjusted dose based on forced dose titration period
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Primary Outcome(s)
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Change in Glycemic measure HbA1cTimepoint: baseline to 52 weeks (1 year
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Secondary Outcome(s)
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Absolute change in body weightTimepoint: baseline to 52 weeks (1 year
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Secondary ID(s)
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EFC10007
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NCT00449605
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Source(s) of Monetary Support
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Sanofi-Synthelabo (India)Ltd
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