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Sitagliptin in Prevention of Type 2 Diabetes Mellitus (SITAGLIPTIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01038648
Recruitment Status : Withdrawn
First Posted : December 24, 2009
Last Update Posted : December 30, 2015
Information provided by:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Drug: Sitagliptin Other: life style modification at base line Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Does the DPP4 Inhibitor Sitagliptin Have a Role in Preventing Type 2 Diabetes- A Randomised Controlled Study.
Study Start Date : December 2011
Estimated Primary Completion Date : February 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: 1
Advice life style at baseline only
Other: life style modification at base line
Advice on physical activity, diet and drug adherence.
Active Comparator: sitagliptin arm : 2

100mg/day sitagliptin

advice on life style modification at baseline only

Drug: Sitagliptin

Primary Outcome Measures :
  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 [ Time Frame: At intervals -6 months ]

Secondary Outcome Measures :
  1. 1. Beneficial effects in beta cell function. 2. Changes in insulin resistance 3. Improvement in cardiovascular risk factors by Sitagliptin. [ Time Frame: Annual ]

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Subjects with IGT in the age group of 30-55 years (n=900) will be identified by screening with a standard OGTT.

Exclusion Criteria:

  1. Known diabetes
  2. Pregnant women
  3. Alcohol abuse
  4. Transferable jobs.
  5. Subjects with major illness like cancer, hepatic or cardiac diseases.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01038648

Dr.Ambady Ramachandran
Chennai, Tamil nadu, India, 600 008
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

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.

Responsible Party: A. Ramachandran / Chairman / Managing Director / President, IDRF & ARH Identifier: NCT01038648     History of Changes
Other Study ID Numbers: SITAGLIPTIN-003 IDRF
First Posted: December 24, 2009    Key Record Dates
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:
Type 2 diabetes
Prevention of type 2 diabetes

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin Phosphate
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action