MK0431A Comparative Study in Patients With Type 2 Diabetes (0431A-079)(COMPLETED)
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|ClinicalTrials.gov Identifier: NCT00482729|
Recruitment Status : Completed
First Posted : June 5, 2007
Results First Posted : March 15, 2010
Last Update Posted : June 9, 2017
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: sitagliptin phosphate (+) metformin hydrochloride Drug: metformin||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1246 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized, Double-Blind, Active-Comparator Controlled, Clinical Trial to Study the Efficacy and Safety of MK0431A for the Treatment of Patients With Type 2 Diabetes Mellitus (T2DM)|
|Actual Study Start Date :||June 19, 2007|
|Actual Primary Completion Date :||November 3, 2008|
|Actual Study Completion Date :||April 27, 2009|
Arm 1: drug
Drug: sitagliptin phosphate (+) metformin hydrochloride
sitagliptin/Metformin HCl 50/500 mg tablet bid, titrating up to sitagliptin/Metformin HCl 50/1000 mg tablet over 4 weeks; for a 44-wk treatment period.
Active Comparator: 2
Arm 2: active comparator
metformin 500 mg tablet bid, titrating up to 1000 mg tablets bid for a 44-wk treatment period
- Change From Baseline in Hemoglobin A1c (A1C) at Week 18 [ Time Frame: Baseline and Week 18 ]A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
- Number of Patients With A1C < 7.0% at Week 18 [ Time Frame: Week 18 ]
- Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18 [ Time Frame: Baseline and Week 18 ]FPG is measured as mg/dL. Thus, this change from baseline reflects the Week 18 FPG mg/dL minus the Week 0 FPG mg/dL.
- Change From Baseline in A1C at Week 44 [ Time Frame: Baseline and Week 44 ]A1C is measured as percent. Thus, this change from baseline reflects the Week 44 A1C percent minus the Week 0 A1C percent.
- Number of Patients With A1C < 7.0% at Week 44 [ Time Frame: Week 44 ]
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): NCT00482729
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|