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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00653302 |
Primary objective:
Secondary objectives:
Safety:
Condition | Intervention | Phase |
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Type 2 Diabetes |
Drug: Lantus (insulin glargine) + Glucophage (Metformin) |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Assessment of the Phenotype of the Type 2 Diabetic Responders to the First Insulinisation Using Lantus (Insulin Glargine) Plus Glucophage (Metformin) Combination After Failure in OADs Treatment |
Enrollment: | 280 |
Study Start Date: | April 2003 |
Study Completion Date: | October 2005 |
Primary Completion Date: | September 2004 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Lantus once a day plus Glucophage 1000mg, twice a day per os
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Drug: Lantus (insulin glargine) + Glucophage (Metformin) |
Ages Eligible for Study: | 30 Years to 69 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Type 2 diabetes treated with oral bi or tritherapy for at least 6 months
Exclusion Criteria:
Responsible Party: | sanofi-aventis France ( Nathalie Billon/Study Director ) |
Study ID Numbers: | HOE901_4043 |
Study First Received: | April 1, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00653302 |
Health Authority: | France: Afssaps - French Health Products Safety Agency |
Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |