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Sponsored by: |
Handok Pharmaceuticals Co., Ltd. |
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Information provided by: | Handok Pharmaceuticals Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT00612144 |
The aim of this study is to compare the efficacy and safety of early combination therapy with Amaryl M with that of uptitration of metformin monotherapy in patients with type 2 DM inadequately controlled by prior monotherapy with metformin.
Condition | Intervention | Phase |
---|---|---|
Type 2 Diabetes Mellitus |
Drug: Glimepiride/metformin fixed combination Drug: Metformin HCl |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multicenter, Randomized, Parallel-Group, Open Study to Compare the Efficacy and Safety of Early Combination Therapy With Amaryl M to Metformin Uptitration in Type 2 DM Patients Inadequately Controlled on Metformin HCL |
Estimated Enrollment: | 192 |
Study Start Date: | December 2007 |
Estimated Study Completion Date: | March 2009 |
Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Amaryl M group
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Drug: Glimepiride/metformin fixed combination
Amaryl M 1/250mg~4/1000mg bid for 12~26 weeks
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2: Active Comparator
Metformin group
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Drug: Metformin HCl
Metformin HCl 500mg~1250mg bid for 12~26 weeks
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Treatment algorithms for type 2 DM generally employ monotherapy as a first-line pharmacologic treatment option. Disease progression renders monotherapy less effective in controlling blood glucose over time, with approximately half of the patients requiring additional therapy by 3 years after diagnosis. As a result, the use of multiple pharmacologic agents to control blood glucose is well accepted.
In combination therapy, selection of suitable drug may be individualized depending on their health conditions. However, it is advisable to select drugs having different mechanism considering their complimentary action with each other. Therefore, sulfonylureas and metformin HCL is the best combination in which "insulin deficiency" and "insulin resistance", the basic two pathophysiologies in type 2 diabetes could be targeted. The efficacy and safety of the combination with sulfonylureas and metformin HCL have been proven in numerous clinical studies as combination is more effective than monotherapy using each drug in blood glucose control.
Also, new approaches are required in order to attain and maintain good glycaemic control over time and aggressive earlier introduction of combination therapy is being increasingly recommended over conventional stepwise strategies.
Ages Eligible for Study: | 30 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Concomitant treatment prohibited during the study period
Contact: Yoon Joo CHO | yoonjoo.cho@handok.com |
Korea, Republic of | |
Handok Pharmaceuticals, Co., LTD | Recruiting |
Seoul, Korea, Republic of | |
Contact: Hyo Young RHIM, MD |
Principal Investigator: | Dong Seob CHOI | Korea University Anam Hospital |
Responsible Party: | Clinical Research Team ( Yoon Joo Cho, Clinical Research Manager ) |
Study ID Numbers: | GLIME_L_02861 |
Study First Received: | January 7, 2008 |
Last Updated: | January 28, 2008 |
ClinicalTrials.gov Identifier: | NCT00612144 |
Health Authority: | Korea: Food and Drug Administration |
Type 2 DM |
Glimepiride Metabolic Diseases Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Metabolic disorder Glucose Metabolism Disorders |
Hypoglycemic Agents Immunologic Factors Therapeutic Uses Physiological Effects of Drugs |
Cardiovascular Agents Anti-Arrhythmia Agents Immunosuppressive Agents Pharmacologic Actions |