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Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Pilot Case Control Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Diabetes Foundation, India.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Diabetes Foundation, India
ClinicalTrials.gov Identifier:
NCT00964184
First received: August 21, 2009
Last updated: May 26, 2010
Last verified: August 2009
History of Changes
  Purpose

This is a phase IV study of 3.5 years duration to evaluate the phenotypic and genetic correlates of diabetes (non-Type 1 in young non-obese Asian Indians in North India and pilot case control study to evaluate the efficacy of sitagliptin (DPP-4 inhibitor) in a sub-group of the study population.


Condition Intervention Phase
Diabetes Mellitus, Type 2
 Drug: Metformin
Drug: Placebo
Behavioral: Lifestyle Modification
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Diabetes Foundation, India:

Primary Outcome Measures:
  • Change of HbA1c from baseline at the end of 18 weeks in the drug group as compared to placebo [ Time Frame: At baseline, 6 weeks, 12 weeks and 18 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in HbA1c, blood glucose, pro-insulin, insulin and C-Peptide (F/ PP) at end of 6 and 12 weeks [ Time Frame: At 6 and 12 weeks ] [ Designated as safety issue: Yes ]
  • Change in body weight, serum lipids at 18 weeks [ Time Frame: At 18 weeks ] [ Designated as safety issue: Yes ]
  • Assessment of safety profile of sitagliptin [ Time Frame: At 6 ,12 and 18 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 240
Study Start Date: September 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Metformin
    less than 1 gram per day
    Drug: Placebo
    less than 1 gram per day
    Behavioral: Lifestyle Modification
    Lifestyle modification
Detailed Description:

A phase IV on T2DM with BMI < 25 kg/m2 and age 14-40 years.

Primary Objectives:

  • To investigate phenotype (body composition, anthropometry, pancreatic imaging and endocrine function, insulin resistance, autoantibodies, and other biochemical variables) and genetic (known mutations and polymorphisms) correlates in young (age 14-40 years) diabetic patients (non-type 1).

Secondary Objectives:

  • To study anthropometric and body fat distribution including truncal fat, subcutaneous and intra-abdominal fat in non-obese young patients with diabetes (non-type 1).
  • To study whether insulin secretion, insulin resistance or a combination of both is/are the predominant defect(s) in non-obese young diabetics (non-type 1).
  • To study the prevalence of autoimmunity and/or specific genetic abnormalities in this subgroup of diabetics.
  • To estimate approximate prevalence of diagnostic subcategories based on the sample of population, and profile of complications in each category.
  • To propose rational use of specialized investigations (e.g. GAD65, HNF-1α mutations etc) while investigating a newly diagnosed young diabetic.
  • To determine the rational therapeutic option and prognosis in this sub-population of diabetics based on anthropometric, biochemical, and etiological profiles.
  • Sample size: 205 patients to be enrolled and 120 patients to be enrolled for sub group study
  Eligibility

Ages Eligible for Study:   14 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Young (18 to 40 years) patients with diabetes (not on insulin therapy) during the past 6 months and having BMI <25 kg/m2.
  • Drug naïve patients
  • Patients on mono-therapy with metformin (< 1g/day).

Exclusion Criteria:

  • Type 1 diabetes
  • Type 2 Diabetes on any other oral hypoglycemic agent other than metformin
  • Pregnancy or lactation
  • Insulin or Sulfonylurea treatment within the past 3 months
  • Has received any investigational drug with the past 60 days
  • History of prior allergy or hypersensitivity to any drug (unless approved by investigator)
  • HbA1c < 7.5% or > 8.5%.
  • Unstable glycemic control, requiring addition of 2nd oral agent/insulin or frequent up-titration of dose of metformin.
  • Any patient on insulin.
  • Females of child bearing potential who are not using adequate contraception during the study period.
  • Insulin dependent or history of ketoacidosis requiring hospitalization
  • Acute infections
  • Advanced end-organ damage (CLD, CRF etc.)
  • Diabetes with clinically significant or advanced end-organ damage
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964184

Contacts
Contact: Anoop Misra +91-11-42776222 ext 5030 anoopmisra@gmail.com

Locations
India
Fortis Flt Lt Rajan Dhall Hospital Recruiting
New Delhi, Delhi, India, 110070
Contact: Anoop Misra     +91-11-42776222 ext 5030     anoopmisra@gmail.com    
Principal Investigator: Anoop Misra            
Sponsors and Collaborators
Diabetes Foundation, India
  More Information

No publications provided

Responsible Party: Dr. Anoop Misra, Diabetes Foundation (India)
ClinicalTrials.gov Identifier: NCT00964184     History of Changes
Other Study ID Numbers: LeanDM-01
Study First Received: August 21, 2009
Last Updated: May 26, 2010
Health Authority: India: Institutional Review Board

Keywords provided by Diabetes Foundation, India:
Maturity onset diabetes of the young 3 protein, human

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013