DiabetesPhase 1NCT00276497
Role of Pioglitazone in Preventing Diabetes
A Phase 1 study testing Pioglitazone in people with Diabetes, run by M.V. Hospital for Diabetes.
Trial summary
A three year prospective, double blinded, placebo controlled, randomized clinical trial in impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing the conversion to Diabetes. Read more about this study
- Who is it for?
- Ages 35 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Pioglitazone
- How many people
- Not given
- Where
- No sites listed yet
- Study dates
- Oct 2003to May 2008
- Phase
- Phase 1
- 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 35 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Both male and female
- Age 35 - 55 years
- No known history of diabetes
- Willing and available for a 3 years study
Who cannot join
- Pregnant women
- Subjects with major illness such as cancer, hepatic or cardiac diseases
- Transferable jobs
About this study
A three year prospective, double blinded, placebo controlled, randomized clinical trial in impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing the conversion to Diabetes.
Read the detailed description
A randomized controlled study was designed to find out whether pioglitazone will prevent the conversion to diabetes in subjects who are non obese and with impaired glucose tolerance.
It is a double blind prospective study for 3 years. The study was started in October 2003 and randomization was completed in May 2005. A total of 6643 subjects were screened and 406 were randomized either to pioglitazone or placebo(investigator blinded-groups assigned A and B). At randomisation subjects were given standard advice on diet,exercise and benefits of life style modifications.
Subjects both male and female, aged between 35 and 55 years, with no known history of diabetes, willing and available for a 3 year study alone were screened. Pregnant women, subjects with major illness such as cancer, hepatic or cardiac diseases and on transferable jobs were excluded from the study. The initial dose of tablet was 15mg o.d. which was titrated after a month to 30 mg o.d. in subjects who did not show any adverse events.
The subjects will be undergoing annual reviews with a repeat OGTT, for 3 years. An interim review at every six months is also being done. Proforma containing details of anthropometry, occupation, physical activity, dietary habits, details of medications, regularity of treatment will be done at each interview.
The main expected outcomes of the study will be a reduction in conversion of IGT to diabetes and benefits of the drug on anthropometric variables and biochemical parameters.
- Conditions
- Diabetes
- Being tested
- Pioglitazone
- Keywords
- Impaired glucose tolerance, Intervention, Prevention
- Medical subject headings
- Diabetes Mellitus, Glucose Intolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in conversion of IGT to diabetes
Secondary outcomes (1)
benefits of the drug on anthropometric variables and biochemical parameters
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2006 (estimated)
- Study startOct 2003
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- M.V. Hospital for Diabetes
- Sponsor type
- University, hospital or other
- Collaborators
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- Investigators
- Ambady Ramachandran, MD,PhD,DSc, Principal investigator, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes hospitals, 28, Marshall's Road, Egmore, Chennai-600 008. India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00276497
- Sponsor's protocol ID
- IDPP2
- Status last verified
- Apr 2009
- First submitted
- 12 Jan 2006
- Last updated
- 6 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ramachandran A, Snehalatha C, Mary S, Selvam S, Kumar CK, Seeli AC, Shetty AS. Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2). Diabetologia. 2009 Jun;52(6):1019-26. doi: 10.1007/s00125-009-1315-x. Epub 2009 Mar 10.
PubMed 19277602Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
PubMed 33210751
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Pioglitazone in Preventing Diabetes
- ClinicalTrials.gov ID
- NCT00276497
- Acronym / sponsor ID
- IDPP2
- Conditions
- Diabetes
- Keywords
- Impaired glucose tolerance, Intervention, Prevention
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- M.V. Hospital for DiabetesUniversity, hospital or other
- Collaborators
- India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
- Study start
- Oct 2003
- Study completion
- May 2008
- First posted
- 13 Jan 2006 (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.
A three year prospective, double blinded, placebo controlled, randomized clinical trial in impaired glucose tolerance (IGT) subjects to study the effect of pioglitazone in preventing the conversion to Diabetes.
Detailed description
A randomized controlled study was designed to find out whether pioglitazone will prevent the conversion to diabetes in subjects who are non obese and with impaired glucose tolerance.
It is a double blind prospective study for 3 years. The study was started in October 2003 and randomization was completed in May 2005. A total of 6643 subjects were screened and 406 were randomized either to pioglitazone or placebo(investigator blinded-groups assigned A and B). At randomisation subjects were given standard advice on diet,exercise and benefits of life style modifications.
Subjects both male and female, aged between 35 and 55 years, with no known history of diabetes, willing and available for a 3 year study alone were screened. Pregnant women, subjects with major illness such as cancer, hepatic or cardiac diseases and on transferable jobs were excluded from the study. The initial dose of tablet was 15mg o.d. which was titrated after a month to 30 mg o.d. in subjects who did not show any adverse events.
The subjects will be undergoing annual reviews with a repeat OGTT, for 3 years. An interim review at every six months is also being done. Proforma containing details of anthropometry, occupation, physical activity, dietary habits, details of medications, regularity of treatment will be done at each interview.
The main expected outcomes of the study will be a reduction in conversion of IGT to diabetes and benefits of the drug on anthropometric variables and biochemical parameters.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 35 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Both male and female
- Age 35 - 55 years
- No known history of diabetes
- Willing and available for a 3 years study
Key exclusion criteria (3 listed)
- Pregnant women
- Subjects with major illness such as cancer, hepatic or cardiac diseases
- Transferable jobs
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 |
|---|---|---|
| Pioglitazone | Drug | – |
Primary outcome
Reduction in conversion of IGT to diabetes
1 secondary outcome
benefits of the drug on anthropometric variables and biochemical parameters
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 Apr 2009.
- Results publication: PubMed 19277602Ramachandran A, Snehalatha C, Mary S, Selvam S, Kumar CK, Seeli AC, Shetty AS. Pioglitazone does not enhance the effectiveness of lifestyle modification in preventing conversion of impaired glucose tolerance to diabetes in Asian Indians: results of the Indian Diabetes Prevention Programme-2 (IDPP-2). Diabetologia. 2009 Jun;52(6):1019-26. doi: 10.1007/s00125-009-1315-x. Epub 2009 Mar 10.
- Derived from this study: PubMed 33210751Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
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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.
Ambady Ramachandran, MD,PhD,DSc principal investigator
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes hospitals, 28, Marshall's Road, Egmore, Chennai-600 008. India
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pioglitazone in people with Diabetes, run by M.V. Hospital for Diabetes.
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 4 inclusion and 3 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 Apr 2009. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Reduction in conversion of IGT to diabetes. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00276497, which also lists 2 linked publications.
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 Apr 2009.