| Trial ID: | L2621 |
| Source ID: | NCT00612144
|
| Associated Drug: |
Glimepiride/Metformin Fixed Combination
|
| Title: |
Study Comparing Efficacy and Safety of Amaryl M and Metformin Uptitraion to Type 2 DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Glimepiride/metformin fixed combination|DRUG: Metformin HCl
|
| Outcome Measures: |
Primary: Adjusted mean changes in HbA1c from baseline to the last visit, 12~24 weeks | Secondary: Adjusted mean changes in FPG from baseline to the last visit, 12~24 weeks|Response rate based on HbA1c and FPG levels measured at the last visit, 12~24 weeks|Frequency with hypoglycemic episode, 12~24 weeks|Adverse event, 12~24 weeks|Abnormal change from baseline in clinical laboratory, 12~24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Handok Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
192
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2007-12
|
| Completion Date: |
2009-05
|
| Results First Posted: |
|
| Last Update Posted: |
2013-03-28
|
| Locations: |
Handok Pharmaceuticals, Co., LTD, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00612144
|
