A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00411554|
Recruitment Status : Completed
First Posted : December 14, 2006
Results First Posted : September 25, 2009
Last Update Posted : February 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Non-Insulin-Dependent||Drug: sitagliptin phosphate Drug: Comparator: voglibose||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||319 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Sitagliptin (MK0431) Phase III Double-blind Comparative Study - Type 2 Diabetes Mellitus -|
|Study Start Date :||January 2007|
|Actual Primary Completion Date :||August 2007|
|Actual Study Completion Date :||August 2007|
Experimental: Sitagliptin 50 mg QD
sitagliptin 50 mg orally once daily (QD=once daily)
Drug: sitagliptin phosphate
sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
Other Name: MK0431
Active Comparator: Voglibose 0.2 mg TID
voglibose 0.2 mg orally three times daily (TID= three times daily)
Drug: Comparator: voglibose
voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
Other Name: voglibose
- Change From Baseline in HbA1c at Week 12 [ Time Frame: Baseline and Week 12 ]HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
- Change From Baseline in Fasting Plasma Glucose at Week 12 [ Time Frame: Baseline and Week 12 ]Change from baseline at Week 12 is defined as fasting plasma glucose at Week 12 minus fasting plasma glucose at Week 0.
- Change From Baseline in 2 Hour Postprandial Glucose at Week 12 [ Time Frame: Baseline and Week 12 ]Change from baseline at Week 12 is defined as 2-hour postprandial glucose Week 12 minus 2-hour postprandial glucose Week 0.
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): NCT00411554
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|