| Trial ID: | L3088 |
| Source ID: | NCT01245166
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| Associated Drug: |
Acarbose
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| Title: |
A Phase III Randomized, Double-blind, Parallel-group Study to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg Plus Acarbose 50 mg Tablets) Versus Acarbose Alone in Subjects With Type 2 Diabetes Mellitus
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| Acronym: |
|
| Status: |
UNKNOWN
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| Study Results: |
NO
|
| Results: |
|
| Conditions: |
The Objectives of the Study is to Evaluate the Efficacy and Safety of Acarmet (Metformin HCl 500 mg|Plus Acarbose 50 mg Tablets) Thrice Daily Versus Acarbose 50 mg Thrice Daily Over 16 Weeks in|Subjects With Type 2 Diabetes Mellitus.
|
| Interventions: |
DRUG: Acarbose|DRUG: Metformin/Acarbose
|
| Outcome Measures: |
Primary: The changes from baseline in HbA1c to the end of treatment period, -4 weeks, 0 week, 8 weeks, 12 weeks, 16 weeks | Secondary: the change from baseline to the end of treatment in FBG, PBG, lipid profiles, and body weight. The safety evaluation will include: 1) Adverse events; 2) Laboratory data; 3) Physical examination; 4) Vital signs; 5) 12- lead ECG, -4 weeks, 0 week, 4 weeks, 8 weeks, 12 weeks, 16 weeks
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| Sponsor/Collaborators: |
Sponsor: Lotus Pharmaceutical
|
| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE3
|
| Enrollment: |
220
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
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| Start Date: |
2010-11
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| Completion Date: |
2011-12
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| Results First Posted: |
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| Last Update Posted: |
2010-11-22
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| Locations: |
Taichung Veterans General Hospital, Taichung, 40705, Taiwan
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| URL: |
https://clinicaltrials.gov/show/NCT01245166
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