CompletedPhase 4

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

India133 participantsStarted 2009-09

Plain-language 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.

Who can participate

Age range

14 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HbA1c

Timeframe: 18 weeks

HbA1C

Timeframe: 12 weeks

Trial details

NCT IDNCT00964184

SponsorDiabetes Foundation, India

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-07

View on ClinicalTrials.gov More Diabetes Mellitus, Type 2 trials

Who can participate

Age range

14 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.