Clinical trial NCT00964184: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Keywords: Maturity onset diabetes of the young 3 protein, human
Lead sponsor: Diabetes Foundation, India
Sponsor class: OTHER
First posted: 2009-08-24
Enrollment: 133
Sex: ALL
Minimum age (years): 14
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility 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

Primary outcomes:
measure: HbA1c
timeFrame: 18 weeks
measure: HbA1C
timeFrame: 12 weeks
Secondary outcomes:
measure: Assessment of safety profile of sitagliptin
timeFrame: 18 weeks
measure: insulin
timeFrame: 12 weeks
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Fortis Flt Lt Rajan Dhall Hospital
state: Delhi
Study officials:
affiliation: Diabetes Foundation, India
name: Anoop Misra
role: PRINCIPAL_INVESTIGATOR
References: