Diabetes Mellitus, Type 2Phase 4NCT00964184
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
A Phase 4 study testing Metformin and Lifestyle modification in people with Diabetes Mellitus, Type 2, run by Diabetes Foundation, India at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 14 to 40 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Metformin and Lifestyle modification
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 133 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2009to Jul 2015
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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).
Who cannot join
- 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)
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
India1 site
Fortis Flt Lt Rajan Dhall Hospital
New Delhi, National Capital Territory of Delhi, 110070
About this study
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.
Read the 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
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Metformin, Lifestyle modification
- Keywords
- Maturity onset diabetes of the young 3 protein, human
- Medical subject headings
- Diabetes Mellitus, Type 2, Maturity-Onset Diabetes of the Young, Type 3
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Lifestyle modificationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Drug | Experimental | 1 gm metformin per day Receives: Drug: Metformin |
| control | Other | lifestyle intervention Receives: Behavioral: Lifestyle modification |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 18 weeks
HbA1C
Measured: 12 weeks
Secondary outcomes (2)
Assessment of safety profile of sitagliptin
Measured: 18 weeks
insulin
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2015
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 133 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Foundation, India
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Anoop Misra, Diabetes Foundation, India
- Investigators
- Anoop Misra, Principal investigator, Diabetes Foundation, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964184
- Sponsor's protocol ID
- LeanDM-01
- Status last verified
- Aug 2015
- First submitted
- 21 Aug 2009
- Last updated
- 6 Aug 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00964184
- Acronym / sponsor ID
- LeanDM-01
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- Maturity onset diabetes of the young 3 protein, human
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 133 participants (actual)
- Lead sponsor
- Diabetes Foundation, IndiaUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 24 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drug | Experimental | Drug: Metformin1 gm metformin per day |
| control | Other | Behavioral: Lifestyle modificationlifestyle intervention |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Metformin | Drug | Drug |
| Lifestyle modification | Behavioural | control |
Primary outcome
HbA1c
Time frame: 18 weeks
HbA1C
Time frame: 12 weeks
2 secondary outcomes
Assessment of safety profile of sitagliptin
Time frame: 18 weeks
insulin
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anoop Misra principal investigator
Diabetes Foundation, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin and Lifestyle modification in people with Diabetes Mellitus, Type 2, run by Diabetes Foundation, India at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 18 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2015.