Glimepiride vs Metformin as Monotherapy in Pediatric Subjects With Type 2 Diabetes Mellitus
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|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)|
|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|
|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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|