MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus (0431-040)
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|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|
|Actual Primary Completion Date :||March 2007|
|Actual 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.
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): NCT00289848
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|