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| Sponsor: | Handok Pharmaceuticals Co., Ltd. |
|---|---|
| Information provided by: | Handok Pharmaceuticals Co., Ltd. |
| ClinicalTrials.gov Identifier: | NCT00437554 |
Purpose
Primary:
To show the equivalence in terms of efficacy glycated hemoglobin (HbA1c) of glimepiride/metformin slow-release combination tablet (Amaryl M SR 2/500) once daily compared with fixed-dose glimepiride/metformin combination tablet (Amaryl M 1/250) twice a day on HbA1c in patients with type 2 Diabetes Mellitus (DM)
Secondary: To compare the following parameters in two treatment arm
Safety:
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Type 2 |
Drug: Glimepiride |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double-Blind, Dose Comparison, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A 16-Week Controlled, Double Blind, Double Dummy, Randomized, Two Arm Parallel-Group Study to Compare the Efficacy and Safety of Amaryl M 1/250 mg b.i.d vs. Amaryl M SR 2/500 mg od. in Patients With Type 2 Diabetes Mellitus |
| Estimated Enrollment: | 188 |
| Study Start Date: | August 2006 |
| Study Completion Date: | July 2007 |
Eligibility| Ages Eligible for Study: | 30 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.
Contacts and Locations
More Information
| Study ID Numbers: | GLIME_L_01019 |
| Study First Received: | February 20, 2007 |
| Last Updated: | November 28, 2007 |
| ClinicalTrials.gov Identifier: | NCT00437554 History of Changes |
| Health Authority: | Korea: Food and Drug Administration |
|
Metabolic Diseases Immunologic Factors Physiological Effects of Drugs Diabetes Mellitus Endocrine System Diseases Cardiovascular Agents Immunosuppressive Agents |
Pharmacologic Actions Glimepiride Hypoglycemic Agents Therapeutic Uses Diabetes Mellitus, Type 2 Anti-Arrhythmia Agents Glucose Metabolism Disorders |