MK0431 (Sitagliptin) and Metformin Co-Administration Factorial Study in Patients With Type 2 Diabetes Mellitus (0431-036)
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
3 other identifiers
interventional
1,208
0 countries
N/A
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 type-2-diabetes-mellitus
Started Mar 2005
Longer than P75 for phase_3 type-2-diabetes-mellitus
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 15, 2005
CompletedFirst Posted
Study publicly available on registry
February 16, 2005
CompletedStudy Start
First participant enrolled
March 17, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 25, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 21, 2008
CompletedResults Posted
Study results publicly available
May 19, 2009
CompletedMay 5, 2017
March 1, 2017
1.4 years
February 15, 2005
February 19, 2009
March 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 24
HbA1c is measured as a percent. This change from baseline reflects the Week 24 HbA1c percent minus the Week 0 HbA1c percent.
Week 24
Secondary Outcomes (8)
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 24
Week 24
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 24
Week 24
Change From Baseline in HbA1c (Hemoglobin A1C) at Week 54
Week 54
Change From Baseline in FPG (Fasting Plasma Glucose) at Week 54
Week 54
Change From Baseline in 2-Hour PMG (Post-Meal Glucose) at Week 54
Week 54
- +3 more secondary outcomes
Study Arms (7)
1
EXPERIMENTALMK0431 100 mg q.d.
2
ACTIVE COMPARATORMetformin 500 mg b.i.d.
3
ACTIVE COMPARATORMetformin 1000 mg b.i.d.
4
EXPERIMENTALCoadministration of MK0431 and Metformin 50/500 mg b.i.d.
5
EXPERIMENTALCoadministration of MK0431 and Metformin 50/1000 mg b.i.d.
6
PLACEBO COMPARATORPlacebo/Metformin 1000 mg b.i.d.
7
EXPERIMENTALNon-Randomized, Open-Label: Coadministration MK0431 and Metformin 50/1000 mg b.i.d.
Interventions
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.
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.
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.
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.
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.
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.
Eligibility Criteria
You may qualify if:
- Week Base Study:
- Patients between the ages of 18 and 78 with Type 2 Diabetes Mellitus (a specific type of diabetes)
- Week Extension Study:
- Patients who complete the 54-week base study are eligible to enter the 50-week extension study
You may not qualify if:
- Patients who do not have Type 2 Diabetes Mellitus (a specific type of diabetes)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Goldstein BJ, Feinglos MN, Lunceford JK, Johnson J, Williams-Herman DE; Sitagliptin 036 Study Group. Effect of initial combination therapy with sitagliptin, a dipeptidyl peptidase-4 inhibitor, and metformin on glycemic control in patients with type 2 diabetes. Diabetes Care. 2007 Aug;30(8):1979-87. doi: 10.2337/dc07-0627. Epub 2007 May 7.
PMID: 17485570BACKGROUNDGnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.
PMID: 32501595DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Non-serious adverse experience results represent those events included in the primary safety analysis for this study (i.e., events that occurred prior to the initiation of glycemic rescue therapy).
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2005
First Posted
February 16, 2005
Study Start
March 17, 2005
Primary Completion
July 25, 2006
Study Completion
February 21, 2008
Last Updated
May 5, 2017
Results First Posted
May 19, 2009
Record last verified: 2017-03