Sitagliptin in Prevention of Type 2 Diabetes Mellitus (SITAGLIPTIN)

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified June 2011 by India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
Sponsor:
Information provided by:
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
ClinicalTrials.gov Identifier:
NCT01038648
First received: December 22, 2009
Last updated: June 24, 2011
Last verified: June 2011
  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
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
100mg/day

Detailed Description:

The DPP-4 inhibitor Sitagliptin may be a suitable preventive agent in subjects with IGT or IFG on account of observed functional improvements in islet cell function and potential protective effect on beta cell mass.

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.
  Eligibility

Ages Eligible for Study:   30 Years to 55 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT01038648

Contacts
Contact: Ambady Ramachandran, M.D, Ph.D, D.Sc +91-44-28582003-05 ext 233 ramachandran@vsnl.com

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

No publications provided

Responsible Party: A. Ramachandran / Chairman / Managing Director / President, IDRF & ARH
ClinicalTrials.gov 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:
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
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 01, 2014