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A Multinational, Open Label, Randomized, Active-controlled, 3-arm Parallel Group, 24-week Study Comparing the Combination of Glimepiride and Metformin Versus Glimepiride and Metformin Alone in Patients With Type 2 Diabetes
Primary Objective: \- To demonstrate the superiority of glimepiride and metformin free combination in comparison to glimepiride or metformin alone in terms of Hb1Ac reduction during a 24-week treatment period in patients with type 2 diabetes mellitus. Secondary Objectives: \- To assess the effects of the free combination of glimepiride and metformin in comparison to glimepiride or metformin alone on: * Percentage of patients reaching HbA1c \< 7% * Percentage of patients reaching HbA1c \< 6.5% * Fasting Plasma Glucose (FPG) * Safety and tolerability
The study duration for each patient is approximately 27 weeks with 3 periods: 2-week screening period followed by 24-week treatment period where patient is assigned to one of the three arms according to randomization, and 3 days follow-up period with a last call phone visit.
Age
18 - 78 years
Sex
ALL
Healthy Volunteers
No
Investigational Site Number 01206
Algeries, Algeria
Investigational Site Number 01203
Oran, Algeria
Investigational Site Number 01205
Sétif, Algeria
Investigational Site Number 17003
El Espinal, Colombia
Investigational Site Number 170001
Manizales, Colombia
Investigational Site Number 81801
Cairo, Egypt
Investigational Site Number 81802
Cairo, Egypt
Investigational Site Number 81803
Cairo, Egypt
Investigational Site Number 32001
Guatemala City, Guatemala
Investigational Site Number 32002
Guatemala City, Guatemala
Start Date
February 1, 2012
Primary Completion Date
January 1, 2014
Completion Date
January 1, 2014
Last Updated
January 21, 2015
538
ACTUAL participants
GLIMEPIRIDE
DRUG
METFORMIN
DRUG
Lead Sponsor
Sanofi
NCT06959901
NCT06574035
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06861062