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

• Status: Completed
• Trial end date: 2015-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Diabetes Foundation, India
• Treatments: Metformin

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