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Sitagliptin in Prevention of Type 2 Diabetes Mellitus (SITAGLIPTIN)

This study has been withdrawn prior to enrollment.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01038648
First Posted: December 24, 2009
Last Update Posted: December 30, 2015
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.
Information provided by:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
  Purpose
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 Intervention Phase
Type 2 Diabetes Drug: Sitagliptin Other: life style modification at base line Phase 3

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:

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

Enrollment: 0
Study Start Date: December 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
100mg/day

  Show Detailed Description

  Eligibility

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
Criteria

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.
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01038648


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

Publications:
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
ClinicalTrials.gov Identifier: NCT01038648     History of Changes
Other Study ID Numbers: SITAGLIPTIN-003 IDRF
First Submitted: December 22, 2009
First Posted: December 24, 2009
Last Update Posted: December 30, 2015
Last Verified: December 2015

Keywords provided by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals:
Sitagliptin
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
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action