Sitagliptin in Prevention of Type 2 Diabetes Mellitus
SITAGLIPTIN
Does the DPP4 Inhibitor Sitagliptin Have a Role in Preventing Type 2 Diabetes- A Randomised Controlled Study.
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The hypothesis is, in subjects with persistent impaired glucose tolerance(IGT) , sitagliptin will decrease the conversion rate to diabetes as compared to a placebo in three years.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2011
Longer than P75 for phase_3 type-2-diabetes
1 active site
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
First Submitted
Initial submission to the registry
December 22, 2009
CompletedFirst Posted
Study publicly available on registry
December 24, 2009
CompletedStudy Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 30, 2015
December 1, 2015
2.2 years
December 22, 2009
December 29, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
1. Rate of conversion of IGT to diabetes. 2. Relative reduction of incidence of diabetes by Sitagliptin among people with IGT compared to Placebo. 3. Increase in reversal of IGT to NGT
At intervals -6 months
Secondary Outcomes (1)
1. Beneficial effects in beta cell function. 2. Changes in insulin resistance 3. Improvement in cardiovascular risk factors by Sitagliptin.
Annual
Study Arms (2)
1
PLACEBO COMPARATORAdvice life style at baseline only
sitagliptin arm : 2
ACTIVE COMPARATOR100mg/day sitagliptin advice on life style modification at baseline only
Interventions
Eligibility Criteria
You may qualify if:
- Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT.
You may not qualify if:
- Known diabetes
- Pregnant women
- Alcohol abuse
- Transferable jobs.
- Subjects with major illness like cancer, hepatic or cardiac diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Dr.Ambady Ramachandran
Chennai, Tamil Nadu, 600 008, India
Related Publications (1)
1.Ramachandran A, Ronald Ma, Snehalatha C. Diabetes in Asia. 2009 Lancet Oct;DOI:10.1016/S0140-6736(09)60937-5. 2.Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Shetty SB, Nanditha A, Ramachandran A. Changes in insulin secretion and insulin sensitivity in relation to the glycemic outcomes in subjects with impaired glucose tolerance in the Indian Diabetes Prevention Programme-1 (IDPP-1).Diabetes Care. 2009 Oct;32(10):1796-801. 3.Ramachandran A, Snehalatha C, Mary S, Selvam S, Sathish Kumar CK, Catherin Seeli A, Samith Shetty A. Pioglitazone does not enhance effectiveness of life style modification in prevening conversion of impaired glucose tolerance to diabetes in Asian Indians-Results of Indian Diabetes Prevention Programme- (IDPP-2).Diabetologia 2009; 52: 1019 - 1026. 4.Ramachandran A, Snehalatha C. Cardiovascular risk factors in normoglycaemic Asian Indian population-Impact of urbanization. Diabetologia 2009 52; 596-599.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
December 22, 2009
First Posted
December 24, 2009
Study Start
December 1, 2011
Primary Completion
February 1, 2014
Study Completion
December 1, 2014
Last Updated
December 30, 2015
Record last verified: 2015-12