Diabetes Mellitus, Type 2Phase 4NCT00437970
Medication in Early Diabetes (MED) Study
A Phase 4 study testing Pioglitazone and Metformin in people with Diabetes Mellitus, Type 2, run by Menzies School of Health Research at 1 site in Australia.
Trial summary
This study compares metformin (current first-line medication) to pioglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of pioglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Pioglitazone and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteAustralia
- Study dates
- Apr 2008to Feb 2009
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Drug naïve Indigenous Australians with Type 2 Diabetes
- Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commences
- Participants must be able to give informed voluntary consent
- Both males and females (females of child bearing potential excluded if not on reliable means of contraception)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Australia1 site
Menzies School of Health Research
Darwin, Northern Territory, 0810
About this study
Official title: Drug naïve Indigenous Australians With Type 2 Diabetes, Enrolled in a Randomised Controlled Trial of Rosiglitazone Versus Metformin Monotherapy to Assess the Effects on Metabolic and Cardiovascular Parameters
This study compares metformin (current first-line medication) to pioglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of pioglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further assessment is required in Indigenous Australians (in whom there is a strong predisposition for central fat deposition). This study will provide evidence regarding the medication appropriate for first line medication in Type 2 diabetes in this high risk population. This study will assist clinicians to make evidenced-based decisions regarding initial medical management of those with Type 2 diabetes (where there is currently a gap in evidence).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Pioglitazone, Metformin
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PioglitazoneDrug
15mg of Pioglitazone taken orally twice a day
MetforminDrug
500 mg of Metformin taken orally twice a day
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Arm A- Metformin Receives: Drug: Metformin |
| B | Active comparator | Arm B- Pioglitazone Receives: Drug: Pioglitazone |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c values
Measured: second monthly
Weight gain
Measured: monthly
Weight distribution
Measured: six monthly
Medication side effects
Measured: monthly
Secondary outcomes (4)
Medication compliance
Measured: monthly
Side effects
Measured: monthly
Lipids
Measured: second monthly
Endothelial dysfunction.
Measured: second monthly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startApr 2008
- Primary completionJan 2009
- Study completionFeb 2009 (estimated)
Why it stopped: Unable to secure supply of the study medication
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menzies School of Health Research
- Sponsor type
- University, hospital or other
- Investigators
- Louise Maple Brown, MBBS PhD FRACP, Principal investigator, Menzies School of Health Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437970
- Sponsor's protocol ID
- DART-MSHR-06-29
- Status last verified
- Apr 2009
- First submitted
- 18 Feb 2007
- Last updated
- 27 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Drug naïve Indigenous Australians With Type 2 Diabetes, Enrolled in a Randomised Controlled Trial of Rosiglitazone Versus Metformin Monotherapy to Assess the Effects on Metabolic and Cardiovascular Parameters
- ClinicalTrials.gov ID
- NCT00437970
- Acronym / sponsor ID
- DART-MSHR-06-29
- Conditions
- Diabetes Mellitus, Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to secure supply of the study medication
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Menzies School of Health ResearchUniversity, hospital or other
- Study start
- Apr 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Feb 2009 (estimated)
- First posted
- 21 Feb 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.
This study compares metformin (current first-line medication) to pioglitazone (a newer diabetic medication currently approved for combination use). Whilst there is good evidence for the benefits of pioglitazone use in other populations, in light of the known weight gain effects of pioglitazone we believe further assessment is required in Indigenous Australians (in whom there is a strong predisposition for central fat deposition). This study will provide evidence regarding the medication appropriate for first line medication in Type 2 diabetes in this high risk population. This study will assist clinicians to make evidenced-based decisions regarding initial medical management of those with Type 2 diabetes (where there is currently a gap in evidence).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: MetforminArm A- Metformin |
| B | Active comparator | Drug: PioglitazoneArm B- Pioglitazone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Drug naïve Indigenous Australians with Type 2 Diabetes
- Permanent resident of Darwin for at least 1 year immediately before and expected to be for at least 1 year after study commences
- Participants must be able to give informed voluntary consent
- Both males and females (females of child bearing potential excluded if not on reliable means of contraception)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Pioglitazone15mg of Pioglitazone taken orally twice a day | Drug | B |
| Metformin500 mg of Metformin taken orally twice a day | Drug | A |
Primary outcome
HbA1c values
Time frame: second monthly
Weight gain
Time frame: monthly
Weight distribution
Time frame: six monthly
Medication side effects
Time frame: monthly
4 secondary outcomes
Medication compliance
Time frame: monthly
Side effects
Time frame: monthly
Lipids
Time frame: second monthly
Endothelial dysfunction.
Time frame: second monthly
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2016.
- Related InfoLink provided by the sponsor.
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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.
Louise Maple Brown, MBBS PhD FRACP principal investigator
Menzies School of Health Research
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 Pioglitazone and Metformin in people with Diabetes Mellitus, Type 2, run by Menzies School of Health Research at 1 site in Australia.
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 0 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: withdrawn, as of the sponsor's last update on 27 May 2016. 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 Australia. 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 was withdrawn before enrolling participants, so there are no results.
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 values (time frame: second monthly). The study lists 4 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 27 May 2016.