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| Sponsor: | Sanofi-Aventis |
|---|---|
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00044447 |
Purpose
The purpose of this study is to assess the efficacy and safety of Amaryl when added to Metformin and Thiazolidinedione (TZD) in non-insulin dependent diabetes mellitus (NIDDM) patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent |
Drug: Glimepiride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Evaluate the Role of the Addition of Amaryl to NIDDM Patients Not Responding to Maximum Dose Metformin and Thiazolidinedione Therapy |
Eligibility| Ages Eligible for Study: | 18 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations
More Information
| Responsible Party: | sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | HOE490/4033 |
| Study First Received: | August 28, 2002 |
| Last Updated: | June 18, 2008 |
| ClinicalTrials.gov Identifier: | NCT00044447 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Metabolic Diseases Immunologic Factors Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases 2,4-thiazolidinedione Cardiovascular Agents Immunosuppressive Agents |
Pharmacologic Actions Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Glucose Metabolism Disorders |