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

Diabetes Mellitus, Type 2 Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964184
• Other study ID #: LeanDM-01
• Status: Completed
• Phase: Phase 4
• First received: August 21, 2009
• Last updated: August 5, 2015
• Start date: September 2009
• Est. completion date: July 2015

Study information

• Verified date: August 2015
• Source: Diabetes Foundation, India
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 133
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 14 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Metformin

Behavioral:
• Lifestyle modification

Locations

Country	Name	City	State
India	Fortis Flt Lt Rajan Dhall Hospital	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Diabetes Foundation, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c		18 weeks	Yes
Primary	HbA1C		12 weeks	Yes
Secondary	Assessment of safety profile of sitagliptin		18 weeks	Yes
Secondary	insulin		12 weeks	Yes