A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)
Sitagliptin (MK0431) Phase III Double-blind Comparative Study - Type 2 Diabetes Mellitus -
2 other identifiers
interventional
319
0 countries
N/A
Brief Summary
The clinical study determines the safety and efficacy of Sitagliptin (MK0431) in patients with type 2 diabetes mellitus who have inadequate glycemic control on diet/exercise therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2007
Shorter than P25 for phase_3
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
December 13, 2006
CompletedFirst Posted
Study publicly available on registry
December 14, 2006
CompletedStudy Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2007
CompletedResults Posted
Study results publicly available
September 25, 2009
CompletedFebruary 5, 2016
February 1, 2016
7 months
December 13, 2006
August 19, 2009
February 3, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in HbA1c at Week 12
HbA1c is measured as a percent. Thus, this change from baseline reflects the Week 12 HbA1c percent minus the Week 0 HbA1c percent.
Baseline and Week 12
Secondary Outcomes (2)
Change From Baseline in Fasting Plasma Glucose at Week 12
Baseline and Week 12
Change From Baseline in 2 Hour Postprandial Glucose at Week 12
Baseline and Week 12
Study Arms (2)
Sitagliptin 50 mg QD
EXPERIMENTALsitagliptin 50 mg orally once daily (QD=once daily)
Voglibose 0.2 mg TID
ACTIVE COMPARATORvoglibose 0.2 mg orally three times daily (TID= three times daily)
Interventions
sitagliptin 50 mg orally once daily QD. Duration of Treatment: 12 Weeks
voglibose 0.2 mg orally three times daily TID. Duration of Treatment: 12 Weeks
Eligibility Criteria
You may qualify if:
- Patients have type 2 diabetes mellitus on diet/exercise therapy
You may not qualify if:
- Patients have type 1 diabetes mellitus
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
Iwamoto Y, Tajima N, Kadowaki T, Nonaka K, Taniguchi T, Nishii M, Arjona Ferreira JC, Amatruda JM. Efficacy and safety of sitagliptin monotherapy compared with voglibose in Japanese patients with type 2 diabetes: a randomized, double-blind trial. Diabetes Obes Metab. 2010 Jul;12(7):613-22. doi: 10.1111/j.1463-1326.2010.01197.x.
PMID: 20590736RESULT
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
December 13, 2006
First Posted
December 14, 2006
Study Start
January 1, 2007
Primary Completion
August 1, 2007
Study Completion
August 1, 2007
Last Updated
February 5, 2016
Results First Posted
September 25, 2009
Record last verified: 2016-02