Study of Sitagliptin in Older Type 2 Diabetics (0431-047)(COMPLETED)
|ClinicalTrials.gov Identifier: NCT00305604|
Recruitment Status : Completed
First Posted : March 22, 2006
Results First Posted : May 1, 2009
Last Update Posted : May 11, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes||Drug: sitagliptin phosphate Drug: Comparator: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||206 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Double-Blind, Randomized, Parallel Group Study to Evaluate the Safety and Efficacy of Sitagliptin in Elderly Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||March 8, 2006|
|Actual Primary Completion Date :||March 12, 2008|
|Actual Study Completion Date :||March 12, 2008|
Active Comparator: 1
Drug: sitagliptin phosphate
Once daily (q.d.) administration of sitagliptin 100 mg tablet (or 50 mg based on creatinine clearance). For up to a 24-wk treatment period.
Other Name: MK0431
Placebo Comparator: 2
Drug: Comparator: Placebo
sitagliptin matching placebo for up to a 24-wk treatment period.
- Change From Baseline in HbA1c (Hemoglobin A1c) at Week 24 [ Time Frame: Baseline and Week 24 ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.
- Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.
- Change From Baseline in 2-hour PPG (Post-prandial Glucose) at Week 24 [ Time Frame: Baseline and Week 24 ]Change from baseline at Week 24 is defined as Week 24 minus Week 0.
- Rapidity of Onset of Action as Determined by Home Glucose Monitoring After 1 Week [ Time Frame: Week 1 ]Fingerstick glucose measurements were taken at 4 times (pre- and 2 hours post-breakfast and dinner) at each of Days -2, 3, and 7. The average of the 4 values was computed for each day. This outcome reflects the Day 7 average minus the Day -2 average.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00305604
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|