An Investigational Drug Study in Patients With Type 2 Diabetes Mellitus (MK0431-023)
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|ClinicalTrials.gov Identifier: NCT00094757|
Recruitment Status : Completed
First Posted : October 25, 2004
Results First Posted : July 21, 2010
Last Update Posted : May 30, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Drug: Comparator: sitagliptin 100 mg Drug: Comparator: sitagliptin 200 mg Drug: Comparator: placebo Drug: Comparator: pioglitazone||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||521 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Multicenter, Randomized, Double-Blind Study of MK0431 in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control|
|Actual Study Start Date :||October 6, 2004|
|Actual Primary Completion Date :||August 17, 2005|
|Actual Study Completion Date :||April 28, 2006|
Experimental: Sitagliptin 100 mg
Sitagliptin 100 mg
Drug: Comparator: sitagliptin 100 mg
sitagliptin 100 mg oral tablet once daily for 54 weeks
Experimental: Sitagliptin 200 mg
Sitagliptin 200 mg
Drug: Comparator: sitagliptin 200 mg
sitagliptin 200 mg (2- 100 mg oral tablets) once daily for 54 weeks
Placebo Comparator: Placebo/Pioglitazone
Drug: Comparator: placebo
placebo oral tablet once daily during Phase A (Weeks 0-18)
Drug: Comparator: pioglitazone
pioglitazone 30 mg oral tablet once daily during Phase B (Weeks 18-54)
- Change From Baseline in A1C at Week 18 [ Time Frame: Weeks 0-18 ]Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent.
- Change From Baseline in FPG at Week 18 [ Time Frame: Weeks 0-18 ]The change from baseline reflects the Week 18 Fasting Plasma Glucose (FPG) minus the Week 0 FPG.
- Change From Baseline in A1C at Week 54 [ Time Frame: Weeks 0-54 ]A1C is measured as percent. Thus this change from baseline reflects the Week 54 A1C percent minus the Week 0 A1C percent.
- Change From Baseline in FPG at Week 54 [ Time Frame: Weeks 0-54 ]The change from baseline reflects the Week 54 FPG minus the Week 0 FPG.
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): NCT00094757
|Study Director:||Medical Monitor||Merck Sharp & Dohme Corp.|