Phenotypic and Genetic Correlates of Diabetes (Non-Type 1) in Young Non-Obese Asian Indians in No… (NCT00964184) | Clinical Trial Compass
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 range14 Years – 40 Years
SexALL
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