| Trial ID: | L6784 |
| Source ID: | NCT00437554
|
| Associated Drug: |
Glimepiride
|
| Title: |
Phase III Study for Glimepiride + Metformin Hydrochloride (Amaryl M) Slow Release (SR)
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Glimepiride
|
| Outcome Measures: |
Primary: Efficacy : Change in HbA1c between baseline and endpoint | Secondary: Efficacy : Change in HbA1c measured at baseline, week 8 and week 16. Change in FPG and PP2h measured at baseline, week 8 and week 16. Response rates in terms of HbA1c, FPG.Patient compliance|Safety: episodes of hypoglycemia, adverse events, laboratory values including hematology, blood chemistry and urinalysis, vital sign and physical examination, Frequency with hypoglycemic episode
|
| Sponsor/Collaborators: |
Sponsor: Handok Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
188
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE|Primary Purpose: TREATMENT
|
| Start Date: |
2006-08
|
| Completion Date: |
2007-07
|
| Results First Posted: |
|
| Last Update Posted: |
2007-11-29
|
| Locations: |
Handok, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00437554
|
