Sulfonylurea Add-on Study in Patients With Type 2 Diabetes Mellitus (0431-035)
A Multicenter, Randomized, Double Blind, Placebo-Controlled 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 Glimepiride Alone or in Combination With Metformin
2 other identifiers
interventional
441
0 countries
N/A
Brief Summary
The purpose of this clinical 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 P50-P75 for phase_3 diabetes-mellitus-type-2
Started Mar 2005
Typical duration for phase_3 diabetes-mellitus-type-2
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
March 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 29, 2005
CompletedFirst Posted
Study publicly available on registry
March 30, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2007
CompletedResults Posted
Study results publicly available
December 17, 2010
CompletedJuly 1, 2015
June 1, 2015
1.3 years
March 29, 2005
November 19, 2010
June 4, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in A1C at Week 24
Hemoglobin A1C (A1C) is measured as percent. Thus this change from baseline reflects the Week 24 A1C percent minus the Week 0 A1C percent.
Baseline and 24 Weeks
Secondary Outcomes (1)
Change From Baseline in FPG at Week 24
Baseline and 24 Weeks
Study Arms (2)
Sitagliptin
EXPERIMENTALSitagliptin 10 mg tablet daily for 54 weeks
Placebo/ Pioglitazone
PLACEBO COMPARATORPlacebo tablet daily for 24 weeks followed by Pioglitazone tablet daily for 30 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Patients with Type 2 Diabetes Mellitus with inadequate glycemic control
You may not qualify if:
- Patients with Type 1 Diabetes Mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Hermansen K, Kipnes M, Luo E, Fanurik D, Khatami H, Stein P; Sitagliptin Study 035 Group. Efficacy and safety of the dipeptidyl peptidase-4 inhibitor, sitagliptin, in patients with type 2 diabetes mellitus inadequately controlled on glimepiride alone or on glimepiride and metformin. Diabetes Obes Metab. 2007 Sep;9(5):733-45. doi: 10.1111/j.1463-1326.2007.00744.x. Epub 2007 Jun 26.
PMID: 17593236BACKGROUND
MeSH Terms
Conditions
Condition 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
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2005
First Posted
March 30, 2005
Study Start
March 1, 2005
Primary Completion
June 1, 2006
Study Completion
January 1, 2007
Last Updated
July 1, 2015
Results First Posted
December 17, 2010
Record last verified: 2015-06