Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-020)(COMPLETED)
A Multicenter, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of the Addition of MK0431 to Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Therapy
3 other identifiers
interventional
701
0 countries
N/A
Brief Summary
The purpose of this study is to determine the safety and efficacy of an investigational drug in patients with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2004
Typical duration for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 30, 2004
CompletedFirst Submitted
Initial submission to the registry
July 2, 2004
CompletedFirst Posted
Study publicly available on registry
July 5, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 20, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
February 2, 2007
CompletedResults Posted
Study results publicly available
December 17, 2010
CompletedMay 5, 2017
March 1, 2017
1.1 years
July 2, 2004
November 19, 2010
March 31, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Hemoglobin A1C (A1C) at Week 24
A1C is measured as a percent. Thus, this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Baseline and Week 24
Secondary Outcomes (2)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 24
Baseline and Week 24
Change From Baseline in 2-hour Post-meal Glucose (PMG) at Week 24
Baseline and Week 24
Study Arms (2)
Sitagliptin 100 mg
EXPERIMENTALThe Sitagliptin 100 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin 100 mg during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin 100 mg and glipizide-matched placebo.
Placebo / Glipizide 5 mg
PLACEBO COMPARATORThe Placebo/Glipizide 5 mg group includes patients who were administered once-daily treatment with oral tablets of sitagliptin-matched placebo during Phase A (Weeks 0-24) of the treatment period. During Phase B (Weeks 24-104) of the treatment period these patients received once-daily coadministered treatment with oral tablets of sitagliptin-matched placebo 100 mg and glipizide 5 mg which was allowed to be uptitrated, in a blinded fashion, to a maximum dose of 15 mg/day.
Interventions
Sitagliptin 100 mg once daily, from Visit 4 through Final Visit, week 104
Placebo (to match Sitagliptin 100 mg) from Visit 4 through Visit 8; Glipizide 5 mg from Visit 8, week 24 to Final Visit (Week 104)
Metformin 1500 mg, once daily, from Visit 2 to Final Visit (Week 104)
Pioglitazone 15 mg once daily, for patients not meeting specific glycemic goals during the placebo-controlled treatment period \[Phase A\], from Visit 5 (Week 6) to Visit 8 (Week 24)
Eligibility Criteria
You may qualify if:
- Patients with type 2 diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (2)
Charbonnel B, Karasik A, Liu J, Wu M, Meininger G; Sitagliptin Study 020 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor sitagliptin added to ongoing metformin therapy in patients with type 2 diabetes inadequately controlled with metformin alone. Diabetes Care. 2006 Dec;29(12):2638-43. doi: 10.2337/dc06-0706.
PMID: 17130197BACKGROUNDXu L, Man CD, Charbonnel B, Meninger G, Davies MJ, Williams-Herman D, Cobelli C, Stein PP. Effect of sitagliptin, a dipeptidyl peptidase-4 inhibitor, on beta-cell function in patients with type 2 diabetes: a model-based approach. Diabetes Obes Metab. 2008 Dec;10(12):1212-20. doi: 10.1111/j.1463-1326.2008.00887.x. Epub 2008 May 12.
PMID: 18476982BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
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
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2004
First Posted
July 5, 2004
Study Start
June 30, 2004
Primary Completion
July 20, 2005
Study Completion
February 2, 2007
Last Updated
May 5, 2017
Results First Posted
December 17, 2010
Record last verified: 2017-03