Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT00353691|
Recruitment Status : Completed
First Posted : July 19, 2006
Last Update Posted : January 11, 2011
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: glimepiride Drug: metformin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Glimepiride Versus Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus: A Single Blind Comparison Study|
|Study Start Date :||October 2002|
|Estimated Study Completion Date :||November 2004|
- Change in HbA1c from baseline to Week 24 or last evaluable ontreatment value.
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00353691
|United States, New Jersey|
|Bridgewater, New Jersey, United States, 08807|
|Study Director:||Karen Barch, B.S.||Sanofi|