Clinical Study on Sitagliptin for Assessment of Glucose-lowering Effects (0431-045)
Phase II Study on Sitagliptin -Assessment of Glucose-lowering Effects
3 other identifiers
interventional
80
0 countries
N/A
Brief Summary
A 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_2
Started Jul 2005
Shorter than P25 for phase_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
July 3, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
February 13, 2006
CompletedFirst Submitted
Initial submission to the registry
September 22, 2008
CompletedFirst Posted
Study publicly available on registry
September 23, 2008
CompletedResults Posted
Study results publicly available
September 25, 2009
CompletedMay 5, 2017
March 1, 2017
8 months
September 22, 2008
August 17, 2009
March 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline in 24-hour Weighted Mean Plasma Glucose
Change from baseline at Week 4 is defined as 24-hour weighted mean glucose (24hr-WMG) at Week 4 minus 24hr-WMG at Week 0.
Baseline and Week 4
Secondary Outcomes (1)
Change From Baseline in Plasma Glucose
Baseline and Week 4
Study Arms (3)
1
PLACEBO COMPARATORPlacebo
2
EXPERIMENTALSitagliptin 100 mg
3
EXPERIMENTALSitagliptin 50 mg
Interventions
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)
Nonaka K, Tsubouchi H, Okuyama K, Fukao Y, Johnson-Levonas AO, Amatruda JM. Effects of once-daily sitagliptin on 24-h glucose control following 4 weeks of treatment in Japanese patients with type 2 diabetes mellitus. Horm Metab Res. 2009 Mar;41(3):232-7. doi: 10.1055/s-0028-1100413. Epub 2009 Feb 27.
PMID: 19253204BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Reported overdoses, regardless of association with reported adverse events, were considered as serious adverse events in this study. The patients for whom the event of overdose was reported had no concomitant AEs with the overdose.
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 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 22, 2008
First Posted
September 23, 2008
Study Start
July 3, 2005
Primary Completion
February 13, 2006
Study Completion
February 13, 2006
Last Updated
May 5, 2017
Results First Posted
September 25, 2009
Record last verified: 2017-03