Sitagliptin in Prevention of Type 2 Diabetes Mellitus (SITAGLIPTIN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals.
Recruitment status was  Not yet recruiting
Information provided by:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals Identifier:
First received: December 22, 2009
Last updated: June 24, 2011
Last verified: June 2011
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 890
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

  Show Detailed Description


Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01038648

Contact: Ambady Ramachandran, M.D, Ph.D, D.Sc +91-44-28582003-05 ext 233

Dr.Ambady Ramachandran Not yet recruiting
Chennai, Tamil nadu, India, 600 008
Contact: Ambady Ramachandran, M.D, D.Sc    +91-44-28582003-05   
Contact: Chamukuttan Snehalatha, M.Sc, D.Sc    +91-44-28582003-05 ext 233   
Principal Investigator: Ambady Ramachandran, M.D, D.Sc         
Sponsors and Collaborators
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
  More Information

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
Study First Received: December 22, 2009
Last Updated: June 24, 2011
Health Authority: India: Institutional Review Board

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
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Dipeptidyl-Peptidase IV Inhibitors
Enzyme Inhibitors
Hormones, Hormone Substitutes, and Hormone Antagonists
Hypoglycemic Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protease Inhibitors processed this record on November 27, 2015