| Trial ID: | L3587 |
| Source ID: | NCT00913367
|
| Associated Drug: |
Glimepiride + Insulin Glargine (Amaryl + Lantus)
|
| Title: |
Efficacy/Safety Study of Amaryl®M 1/500 mg Twice Daily Versus Amaryl® 4 mg Both in Combination With Lantus® in Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: glimepiride + insulin glargine (Amaryl + Lantus)|DRUG: glimepiride/metformin fixed combination+insulin glargine (AmarylM + Lantus)
|
| Outcome Measures: |
Primary: Mean change in HbA1c from baseline to the last visit, 16 weeks | Secondary: Mean change in FPG, insulin, c-peptide from baseline to the last visit Safety; Episodes of hypoglycemia & other adverse events, 16 weeks|Response rate based on HbA1c and FPG levels measured at the last visit, 16 weeks|Mean change in Lantus® dose from baseline to the last visit, 16 weeks|Compliance, 16 weeks|Frequency with hypoglycemic episode, 16weeks|Adverse events, 16 weeks
|
| Sponsor/Collaborators: |
Sponsor: Handok Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
110
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2009-05
|
| Completion Date: |
2010-11
|
| Results First Posted: |
|
| Last Update Posted: |
2013-03-28
|
| Locations: |
HeeYoung Lee, Seoul, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT00913367
|
