Type 1 Diabetes MellitusPhase 1NCT00545857
Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
A Phase 1 study testing pioglitazone in people with Type 1 Diabetes Mellitus, run by Stony Brook University at 1 site in United States.
Trial summary
A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- pioglitazone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2002to May 2012
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with type 1 diabetes mellitus diagnosed within 4 months
- Age > 6 years of age
- Ability to swallow capsule
- Signed informed consent / assent
Who cannot join
- Other illnesses
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas A. Wilson, MD
Stony Brook, New York, 11794-8111
About this study
A study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.
Read the detailed description
Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- pioglitazone, Placebo control
- Keywords
- Type 1 diabetes, Insulin dependent diabetes, Juvenile onset diabetes, pioglitazone
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pioglitazoneDrug
Also called Actos
Pioglitazone daily; dose varies with size
Placebo controlDrug
Also called Actos
Comparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus
| Study group | Role | What they receive |
|---|---|---|
| Pioglitazone | Experimental | Not described Receives: Drug: pioglitazone; Drug: Placebo control |
| Placebo control | Placebo comparator | Not described Receives: Drug: pioglitazone; Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
C-peptide response to a Sustacal meal
Measured: 6 months
Secondary outcomes (2)
Insulin requirement
Measured: 6 months
Hemoglobin A1c
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2007 (estimated)
- Study startJun 2002
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas A. Wilson, Stony Brook University
- Investigators
- Thomas A Wilson, MD, Principal investigator, State University of New York Stony Brook
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00545857
- Sponsor's protocol ID
- 20064114
- Status last verified
- May 2012
- First submitted
- 16 Oct 2007
- Last updated
- 31 May 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tafuri KS, Godil MA, Lane AH, Wilson TA. Effect of pioglitazone on the course of new-onset type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2013;5(4):236-9. doi: 10.4274/Jcrpe.981.
PubMed 24379032
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pioglitazone on the Course of New Onset Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00545857
- Acronym / sponsor ID
- 20064114
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes, Insulin dependent diabetes, Juvenile onset diabetes, pioglitazone
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- Jun 2002
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 17 Oct 2007 (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 study to examine the effect of pioglitazone on the course of new onset type 1 diabetes mellitus.
Detailed description
Thiazolidinediones have been shown to reduce the development of diabetes mellitus in animal models of type 1 diabetes and to reduce the death of beta cells (cells that make insulin) in petri dishes. Pioglitazone is a thiazolidinedione currently approved for the treatment of type 2 diabetes. This study explores the question of whether pioglitazone can preserve beta cell function in patients with recently diagnosed type 1 diabetes mellitus.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pioglitazone | Experimental | Drug: pioglitazone, Drug: Placebo control |
| Placebo control | Placebo comparator | Drug: pioglitazone, Drug: Placebo control |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with type 1 diabetes mellitus diagnosed within 4 months
- Age > 6 years of age
- Ability to swallow capsule
- Signed informed consent / assent
Key exclusion criteria (1 listed)
- Other illnesses
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 |
|---|---|---|
| pioglitazoneAlso: ActosPioglitazone daily; dose varies with size | Drug | Pioglitazone, Placebo control |
| Placebo controlAlso: ActosComparison of pioglitazone vs. placebo on the outcome of type 1 diabetes mellitus | Drug | Pioglitazone, Placebo control |
Primary outcome
C-peptide response to a Sustacal meal
Time frame: 6 months
2 secondary outcomes
Insulin requirement
Time frame: 6 months
Hemoglobin A1c
Time frame: 6 months
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 31 May 2012.
- Derived from this study: PubMed 24379032Tafuri KS, Godil MA, Lane AH, Wilson TA. Effect of pioglitazone on the course of new-onset type 1 diabetes mellitus. J Clin Res Pediatr Endocrinol. 2013;5(4):236-9. doi: 10.4274/Jcrpe.981.
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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.
Thomas A Wilson, MD principal investigator
State University of New York Stony Brook
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing pioglitazone in people with Type 1 Diabetes Mellitus, run by Stony Brook University at 1 site in United States.
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 1 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 31 May 2012. 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 United States. 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. Some participants in this study may receive a placebo. 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?
C-peptide response to a Sustacal meal (time frame: 6 months). 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 NCT00545857, which also lists 1 linked publication.
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 31 May 2012.