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

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

Overview[ - collapse ][ - ]

Purpose	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).
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily) Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily) Drug: Comparator: Placebo (Phase A)/Metformin (Phase B) Drug: Comparator: Metformin 500 mg b.i.d. Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d. Drug: Comparator: Metformin 1000 mg b.i.d.
Phase	Phase 3
Sponsor	Merck Sharp & Dohme Corp.
Responsible Party	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier	NCT00103857
First Received	February 15, 2005
Last Updated	November 12, 2013
Last verified	November 2013

Tracking Information[ + expand ][ + ]

First Received Date	February 15, 2005
Last Updated Date	November 12, 2013
Start Date	March 2005
Estimated Primary Completion Date	February 2008
Current Primary Outcome Measures	Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24 [Time Frame: Week 24] [Designated as safety issue: No]HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Current Secondary Outcome Measures	Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24 [Time Frame: Week 24] [Designated as safety issue: No]Change from baseline at Week 24 is defined as Week 24 minus Week 0. Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24 [Time Frame: Week 24] [Designated as safety issue: No]Change from baseline at Week 24 is defined as Week 24 minus Week 0. Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54 [Time Frame: Week 54] [Designated as safety issue: No]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 [Time Frame: Week 54] [Designated as safety issue: No]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 [Time Frame: Week 54] [Designated as safety issue: No]Change from baseline at Week 54 is defined as Week 54 minus Week 0. Change From Baseline in HbA1c (Hemoglobin A1C) at Week 104 [Time Frame: Week 104] [Designated as safety issue: No]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 [Time Frame: Week 104] [Designated as safety issue: No]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 [Time Frame: Week 104] [Designated as safety issue: No]Change from baseline at Week 104 is defined as Week 104 minus Week 0.

Descriptive Information[ + expand ][ + ]

Brief Title	MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)(COMPLETED)
Official Title	A Multicenter, Randomized, Double-Blind Factorial Study of the Co-Administration of MK0431 and Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control
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 Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Type 2 Diabetes Mellitus
Intervention	Drug: Comparator: MK0431 50 mg b.i.d. (b.i.d. = twice daily) MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take MK0431 50 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks. Other Names: MK0431Drug: Comparator: MK0431 100 mg q.d. (q.d. = once daily) MK0431 oral tablets will be started on Day 1 as two 50 mg tablets (100 mg q.d.) (q.d. = once daily) and continued at this dose throughout the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks. Drug: Comparator: Placebo (Phase A)/Metformin (Phase B) During the placebo-controlled period (Day 1 through Week 24/Phase A), metformin and MK0431 matching placebos will be dispensed as oral tablets. At the beginning of the 30-week active-controlled period (Phase B), metformin will be started as 500 mg q.d. (q.d. = once daily) and up-titrated in 500 mg weekly increments to a stable dose of 1000 mg b.i.d. Patients who complete the 54-week base study and who enter the 50-week extension study will continue to take metformin 1000 mg b.i.d. (b.i.d. = twice daily) for a total placebo/metformin treatment duration of up to 104 weeks. Drug: Comparator: Metformin 500 mg b.i.d. Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased after 1 week to a stable dose of 500 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 500 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks. Drug: Comparator: Open-Label MK0431/Metformin 50/1000 mg b.i.d. MK0431 oral tablets will be started on Day 1 at 50 mg q.d. (q.d. = once daily) and increased after one week to a stable dose of 50 mg b.i.d. (b.i.d. = twice daily) Metformin oral tablets will be started on Day 1 at 500 mg q.d. and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. The open-label treatment period is 24 weeks. Drug: Comparator: Metformin 1000 mg b.i.d. Metformin oral tablets will be started on Day 1 at 500 mg q.d. (q.d. = once daily) and increased by increments of 500 mg per week to achieve a stable dose of 1000 mg b.i.d. (b.i.d. = twice daily) Patients will continue to take metformin 1000 mg b.i.d. for the remainder of the 54-week base study (including the 24-week placebo-controlled Phase A and 30-week active-controlled Phase B) and during the 50-week extension study (for patients who complete the 54-week base study and enter the 50-week extension study) for a total treatment duration of up to 104 weeks.
Study Arm (s)	Experimental: 1 MK0431 100 mg q.d. Active Comparator: 2 Metformin 500 mg b.i.d. Active Comparator: 3 Metformin 1000 mg b.i.d. Experimental: 4 Coadministration of MK0431 and Metformin 50/500 mg b.i.d. Experimental: 5 Coadministration of MK0431 and Metformin 50/1000 mg b.i.d. Placebo Comparator: 6 Placebo/Metformin 1000 mg b.i.d. Experimental: 7 Non-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	1208
Estimated Completion Date	February 2008
Estimated Primary Completion Date	July 2006
Eligibility Criteria	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)
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT00103857
Other Study ID Numbers	0431-036
Has Data Monitoring Committee	No
Information Provided By	Merck Sharp & Dohme Corp.
Study Sponsor	Merck Sharp & Dohme Corp.
Collaborators	Not Provided
Investigators	Study Director: Medical Monitor Merck Sharp & Dohme Corp.
Verification Date	November 2013