MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT00103857
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with Type 2 Diabetes Mellitus (T2DM) (a specific type of diabetes).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-02-15
• Study First Submitted QC: 2005-02-15
• Study First Posted: 2005-02-16
• Study Start: 2005-03-17
• Primary Completion: 2006-07-25
• Study Completion: 2008-02-21
• Results First Submitted: 2009-02-19
• Results First Submitted QC: 2009-03-27
• Results First Posted: 2009-05-19
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-31
• Last Update Posted: 2017-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1208

Inclusion Criteria

54-Week Base Study:

• Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)

  50-Week Extension Study:

• Patients who complete the 54-week base study are eligible to enter the 50-week extension study

Exclusion Criteria

• Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24	Week 24	HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24	Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54	Week 54	HbA1c is measured as a percent. This change from baseline reflects the Week 54 HbA1c percent minus the Week 0 HbA1c percent.
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54	Week 54	Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54	Week 54	Change from baseline at Week 54 is defined as Week 54 minus Week 0.
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104	Week 104	HbA1c is measured as a percent. This change from baseline reflects the Week 104 HbA1c percent minus the Week 0 HbA1c percent.
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 104	Week 104	Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 104	Week 104	Change from baseline at Week 104 is defined as Week 104 minus Week 0.
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24	Week 24	Change from baseline at Week 24 is defined as Week 24 minus Week 0.