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
1 other identifier
interventional
133
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4 diabetes-mellitus-type-2
Started Sep 2009
Longer than P75 for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 21, 2009
CompletedFirst Posted
Study publicly available on registry
August 24, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2015
CompletedAugust 6, 2015
August 1, 2015
5.8 years
August 21, 2009
August 5, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
HbA1c
18 weeks
HbA1C
12 weeks
Secondary Outcomes (2)
Assessment of safety profile of sitagliptin
18 weeks
insulin
12 weeks
Study Arms (2)
Drug
EXPERIMENTAL1 gm metformin per day
control
OTHERlifestyle intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fortis Flt Lt Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, 110070, India
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Anoop Misra
Diabetes Foundation, India
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, Diabetes, Obesity and Metabolic Disorders
Study Record Dates
First Submitted
August 21, 2009
First Posted
August 24, 2009
Study Start
September 1, 2009
Primary Completion
July 1, 2015
Study Completion
July 1, 2015
Last Updated
August 6, 2015
Record last verified: 2015-08