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 | RxWiki

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

Overview[ - collapse ][ - ]

Purpose	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.
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Metformin Drug: Placebo Behavioral: Lifestyle Modification
Phase	Phase 4
Sponsor	Diabetes Foundation, India
Responsible Party	Diabetes Foundation, India
ClinicalTrials.gov Identifier	NCT00964184
First Received	August 21, 2009
Last Updated	February 4, 2014
Last verified	February 2014

Tracking Information[ + expand ][ + ]

First Received Date	August 21, 2009
Last Updated Date	February 4, 2014
Start Date	September 2009
Estimated Primary Completion Date	May 2014
Current Primary Outcome Measures	HbA1c [Time Frame: 18 weeks] [Designated as safety issue: No] HbA1C [Time Frame: 12 weeks]
Current Secondary Outcome Measures	Assessment of safety profile of sitagliptin [Time Frame: 18 weeks] [Designated as safety issue: Yes] insulin [Time Frame: 12 weeks] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief Title	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
Official Title	Not Provided
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
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Condition	Diabetes Mellitus, Type 2
Intervention	Drug: Metformin less than 1 gram per day Drug: Placebo less than 1 gram per day Behavioral: Lifestyle Modification Lifestyle modification
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Recruiting
Estimated Enrollment	240
Estimated Completion Date	May 2014
Estimated Primary Completion Date	March 2014
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
Gender	Both
Ages	14 Years
Accepts Healthy Volunteers	No
Contacts	Contact: Anoop Misra +91-11-42776222 anoopmisra@gmail.com
Location Countries	India

Administrative Information[ + expand ][ + ]

NCT Number	NCT00964184
Other Study ID Numbers	LeanDM-01
Has Data Monitoring Committee	No
Information Provided By	Diabetes Foundation, India
Study Sponsor	Diabetes Foundation, India
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	February 2014

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