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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Diabetes Foundation, India
Sponsor:
Information provided by (Responsible Party):
Dr Anoop Misra, Diabetes Foundation, India
ClinicalTrials.gov Identifier:
NCT00964184
First received: August 21, 2009
Last updated: February 4, 2014
Last verified: February 2014

August 21, 2009
February 4, 2014
September 2009
March 2014   (final data collection date for primary outcome measure)
  • HbA1c [ Time Frame: 18 weeks ] [ Designated as safety issue: No ]
  • HbA1C [ Time Frame: 12 weeks ]
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 ]
Complete list of historical versions of study NCT00964184 on ClinicalTrials.gov Archive Site
  • Assessment of safety profile of sitagliptin [ Time Frame: 18 weeks ] [ Designated as safety issue: Yes ]
  • insulin [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
  • 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 ]
Not Provided
Not Provided
 
Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in North India and A Study to Evaluate the Efficacy of Sitagliptin (DPP-4 Inhibitor) in a Sub-group of the Study Population
Not Provided

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.

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
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: Metformin
    less than 1 gram per day
  • Drug: Placebo
    less than 1 gram per day
  • Behavioral: Lifestyle Modification
    Lifestyle modification
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
May 2014
March 2014   (final data collection date for primary outcome measure)

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
Both
14 Years to 40 Years
No
Contact: Anoop Misra +91-11-42776222 ext 5030 anoopmisra@gmail.com
India
 
NCT00964184
LeanDM-01
No
Dr Anoop Misra, Diabetes Foundation, India
Diabetes Foundation, India
Not Provided
Not Provided
Diabetes Foundation, India
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP