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Sponsored by: |
Sanofi-Aventis |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00311818 |
Primary objective:
Secondary objectives:
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Insulin glargine |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 44-Week, Parallel, Open, Randomized, Multinational, Multi-Center Clinical Trial to Compare Efficacy and Safety of the Combination Therapy of an Oral Anti-Diabetic Drug Treatment With Either HOE901 Insulin Once Daily or Lispro Insulin Analogue at Mealtime in Type 2 Diabetes Mellitus Patients Poorly Controlled With Oral Anti-Diabetic Drug Treatment. |
Study Start Date: | June 2003 |
Primary Completion Date: | May 2005 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Responsible Party: | sanofi-aventis ( Medical Affairs Study Director ) |
Study ID Numbers: | HOE901_4040 |
Study First Received: | April 5, 2006 |
Last Updated: | August 21, 2008 |
ClinicalTrials.gov Identifier: | NCT00311818 |
Health Authority: | Germany: Ethics Commission |
Metabolic Diseases Diabetes Mellitus, Type 2 Glargine Diabetes Mellitus Insulin LISPRO |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders Insulin |
Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |