Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
|ClinicalTrials.gov Identifier: NCT00704132|
Recruitment Status : Completed
First Posted : June 24, 2008
Results First Posted : May 16, 2011
Last Update Posted : May 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus (T2DM)||Drug: Comparator: sitagliptin phosphate Drug: Comparator: placebo (unspecified)||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||A Randomized, Placebo-Controlled Study to Evaluate the Safety, Efficacy and Mechanism of Action of MK0431/Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control|
|Actual Study Start Date :||February 14, 2007|
|Primary Completion Date :||April 28, 2010|
|Study Completion Date :||April 28, 2010|
Participants randomized to this arm will be administered sitagliptin 100mg daily, for six weeks.
Drug: Comparator: sitagliptin phosphate
Sitagliptin tablet 100 mg, administered once daily before the morning meal.
Placebo Comparator: Placebo
Participants randomized to this arm will be administered matching placebo, daily for six weeks.
Drug: Comparator: placebo (unspecified)
Matching placebo tablet, administered once daily before the morning meal.
- Change From Baseline in Glucose 5-Hour Incremental AUC at Week 6 [ Time Frame: Baseline and Week 6 ]Participants underwent the 5-hour meal test prior to randomization (baseline) and was repeated at the conclusion of the 6-week double-blind study period. The change from baseline in Glucose 5-Hour Incremental AUC at Week 6 is computed as the difference between the Week 6 measurement and the baseline measurement.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00704132
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|