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

Phase 4

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Behavioral: Lifestyle modification; Drug: Metformin

• Registration Number: NCT00964184
• Lead Sponsor: Diabetes Foundation, India

Brief Summary

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.

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2009-08-21
• Study First Submitted QC: 2009-08-21
• Study First Posted: 2009-08-24
• Study Start: 2009-09
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-05
• Last Update Posted: 2015-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 133

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).

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control	Lifestyle modification	lifestyle intervention
Drug	Metformin	1 gm metformin per day

Primary Outcome Measures

Name	Time	Method
HbA1c	18 weeks
HbA1C	12 weeks

Secondary Outcome Measures

Name	Time	Method
insulin	12 weeks
Assessment of safety profile of sitagliptin	18 weeks

Trial Locations

Locations (1)

Fortis Flt Lt Rajan Dhall Hospital; 🇮🇳 New Delhi, Delhi, India