Safety/Efficacy of Sitagliptin in Patient w/ Type 2 Diabetes (0431-801)
A Multicenter, Double-Blind, Placebo and Active Controlled, Randomized Study to Evaluate the Safety and Efficacy of the Addition of Sitagliptin 100 mg Once Daily in Patients With Type 2 Diabetes With Inadequate Glycemic Control on Metformin Monotherapy
2 other identifiers
interventional
273
0 countries
N/A
Brief Summary
The purpose of this study is to test the safety and effectiveness of sitagliptin in patients with type 2 diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 type-2-diabetes-mellitus
Started Jun 2006
Shorter than P25 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
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2007
CompletedFirst Submitted
Initial submission to the registry
October 5, 2007
CompletedFirst Posted
Study publicly available on registry
October 10, 2007
CompletedResults Posted
Study results publicly available
June 17, 2010
CompletedAugust 24, 2015
August 1, 2015
9 months
October 5, 2007
May 17, 2010
August 21, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Hemoglobin A1C (A1C) at Week 18
A1C is measured as percent. Thus, this change from baseline reflects the Week 18 A1C percent minus the Week 0 A1C percent. The study hypothesis comparison was between sitagliptin versus placebo.
Baseline and 18 Weeks
Secondary Outcomes (2)
Fasting Plasma Glucose (FPG) at Week 18
Baseline and 18 Weeks
2-hour Post-meal Glucose (PMG) at Week 18
Baseline and 18 Weeks
Study Arms (3)
Sitagliptin
EXPERIMENTALsitagliptin 100 mg
Rosiglitazone
ACTIVE COMPARATORrosiglitazone 8 mg
Placebo
PLACEBO COMPARATORplacebo
Interventions
Sitagliptin 100 mg administered as one oral tablet once daily in the morning for up to 18 weeks.
Rosiglitazone 8 mg administered as two 4 mg capsules once daily in the morning for up to 18 weeks.
placebo - administered as one placebo tablet to match Sitagliptin 100 mg and two placebo capsules to match rosiglitazone 4 mg once daily in the morning for up to 18 weeks.
Open-label metformin was supplied by the Sponsor as 500, 850, or 1000 mg oral tablets administered at a daily dose of \>= 1500 mg.
Eligibility Criteria
You may qualify if:
- Patient has Type 2 diabetes
- Currently taking metformin \>1500 mg/day for at least 10 weeks
- Male or female
You may not qualify if:
- Patient has peripheral edema
- History of type 1 diabetes
- Patient required insulin within prior 8 weeks
- Have participated or are currently participating in another study with an investigational compound or device within 12 weeks of starting this study
- Participating in a weight loss program
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Scott R, Loeys T, Davies MJ, Engel SS; Sitagliptin Study 801 Group. Efficacy and safety of sitagliptin when added to ongoing metformin therapy in patients with type 2 diabetes. Diabetes Obes Metab. 2008 Sep;10(10):959-69. doi: 10.1111/j.1463-1326.2007.00839.x. Epub 2008 Jan 14.
PMID: 18201203BACKGROUND
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
October 5, 2007
First Posted
October 10, 2007
Study Start
June 1, 2006
Primary Completion
March 1, 2007
Study Completion
March 1, 2007
Last Updated
August 24, 2015
Results First Posted
June 17, 2010
Record last verified: 2015-08