| Trial ID: | L2177 |
| Source ID: | NCT00353691
|
| Associated Drug: |
Glimepiride
|
| Title: |
Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: glimepiride|DRUG: metformin
|
| Outcome Measures: |
Primary: Change in HbA1c from baseline to Week 24 or last evaluable ontreatment value. | Secondary: Change in HbA1c from baseline to Week 12|Responder rate, defined as proportion of subjects with HbA1c < 7.0% at Week 24 or last evaluable on-therapy observation|Mean change in fasting SMBG from baseline to each visit at weeks 4, 8, 12, 18 and 24 or last evaluable on-treatment value.|Mean change in fasting plasma glucose (FPG) from baseline to each visit at weeks 4, 8, 12, 18 and 24 or last evaluable on-treatment value.|Percent completers, defined as subjects who continued study medication until completion of all requirements of Visit 6 (Week 18)|Mean change in lipid levels (total cholesterol, HDL cholesterol, LDL cholesterol, and triglycerides) from baseline to Wk 24 or last evaluable on-treatment value.|Mean change in body mass index (BMI) from baseline to Wk 12 and Wk 24 or last evaluable on-treatment value
|
| Sponsor/Collaborators: |
Sponsor: Sanofi
|
| Gender: |
ALL
|
| Age: |
CHILD
|
| Phases: |
PHASE3
|
| Enrollment: |
100
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE|Primary Purpose: TREATMENT
|
| Start Date: |
2002-10
|
| Completion Date: |
2004-11
|
| Results First Posted: |
|
| Last Update Posted: |
2011-01-11
|
| Locations: |
Sanofi-Aventis, Bridgewater, New Jersey, 08807, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT00353691
|
