Sitagliptin Mechanism of Action Study in Patients With Type 2 Diabetes Mellitus (0431-059)
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|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|
|Actual Primary Completion Date :||April 28, 2010|
|Actual 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.
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): NCT00704132
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|