MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
|ClinicalTrials.gov Identifier: NCT00289848|
Recruitment Status : Completed
First Posted : February 10, 2006
Results First Posted : April 2, 2010
Last Update Posted : June 15, 2015
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: sitagliptin phosphate Drug: Comparator: placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||530 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control|
|Study Start Date :||March 2006|
|Primary Completion Date :||March 2007|
|Study Completion Date :||March 2007|
sitagliptin 100 mg
Drug: sitagliptin phosphate
Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks.
Other Name: Januvia
Placebo Comparator: 2
Drug: Comparator: placebo
placebo to match Sitagliptin 100 mg administered as one oral tablet once daily before the morning meal for up to 18 weeks
- Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18 [ Time Frame: Baseline and Week 18 ]A1C was measured as a percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ]Change from baseline at Week 18 is defined as Week 18 FPG minus Week 0 FPG.
- Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18 [ Time Frame: Baseline and Week 18 ]Change from baseline at Week 18 is defined as Week 18 minus Week 0.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00289848
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|