Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2011-12-31
2014-12-31
Brief Summary
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Detailed Description
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Objectives of the study
1. Primary objectives :
\- To test whether the DPP4 inhibitor Sitagliptin is effective in preventing conversion of IGT to diabetes when compared with a placebo.
2. Secondary objectives:
* To assess rates of reversal from IGT to Normal Glucose Tolerance (NGT) in IGT patients administered Sitagliptin
* To assess the effect of Sitagliptin on measure of beta cell function and insulin resistance in patients with IGT.
Study design
Double blind placebo controlled, parallel group study - three years follow up .
Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT. Selected subjects will be randomized to the control arm using placebo and the two study arms using Sitagliptin. At baseline all group will receive a standard advice on lifestyle modification. The dose of sitagliptin will be 100 mg/d. The subjects will be reviewed at 6 monthly intervals and repeat OGTT will be done annually.
Proforma containing details of anthropometry, occupation, physical activity, diet habits, details of medications, regularity of treatment and biochemical investigations will be filled up at each interview.
Investigations:
Initial Screening
1. Demographic data
2. Height, weight, waist and hip measurements.
3. Details of family history of diabetes, hypertension and cardiovascular diseases.
4. History of any other major illness.
5. History of blood pressure and measurements.
6. Details of education and occupation.
7. Diet habits will be analyzed by dietician.
8. Details of physical activity will be assessed by a questionnaire.
Laboratory investigations:
1. Initial OGTT
2. Plasma glucose and HbA1c.
3. Lipid profile
4. Liver function tests
5. Serum amylase and serum lipase
6. Plasma insulin
7. 12 lead ECG.
Review analysis:
1. Review will be done with all clinical and biochemical assessment annually.
2. Evaluation of adherence to prescription will be done at 6 monthly intervals.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Advice life style at baseline only
life style modification at base line
Advice on physical activity, diet and drug adherence.
sitagliptin arm : 2
100mg/day sitagliptin
advice on life style modification at baseline only
Sitagliptin
100mg/day
Interventions
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Sitagliptin
100mg/day
life style modification at base line
Advice on physical activity, diet and drug adherence.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
2. Pregnant women
3. Alcohol abuse
4. Transferable jobs.
5. Subjects with major illness like cancer, hepatic or cardiac diseases.
30 Years
55 Years
ALL
Yes
Sponsors
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India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
OTHER
Responsible Party
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IDRF & ARH
Locations
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Dr.Ambady Ramachandran
Chennai, Tamil Nadu, India
Countries
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References
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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.
Other Identifiers
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SITAGLIPTIN-003 IDRF
Identifier Type: -
Identifier Source: org_study_id