- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00437970
Medication in Early Diabetes (MED) Study
May 26, 2016 updated by: Menzies School of Health Research
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).
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Northern Territory
-
Darwin, Northern Territory, Australia, 0810
- Menzies School of Health Research
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: A
Arm A- Metformin
|
500 mg of Metformin taken orally twice a day
|
ACTIVE_COMPARATOR: B
Arm B- Pioglitazone
|
15mg of Pioglitazone taken orally twice a day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
HbA1c values
Time Frame: second monthly
|
second monthly
|
Weight gain
Time Frame: monthly
|
monthly
|
Weight distribution
Time Frame: six monthly
|
six monthly
|
Medication side effects
Time Frame: monthly
|
monthly
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Medication compliance
Time Frame: monthly
|
monthly
|
Side effects
Time Frame: monthly
|
monthly
|
Lipids
Time Frame: second monthly
|
second monthly
|
Endothelial dysfunction.
Time Frame: second monthly
|
second monthly
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Louise Maple Brown, MBBS PhD FRACP, Menzies School of Health Research
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (ACTUAL)
January 1, 2009
Study Completion (ANTICIPATED)
February 1, 2009
Study Registration Dates
First Submitted
February 18, 2007
First Submitted That Met QC Criteria
February 20, 2007
First Posted (ESTIMATE)
February 21, 2007
Study Record Updates
Last Update Posted (ESTIMATE)
May 27, 2016
Last Update Submitted That Met QC Criteria
May 26, 2016
Last Verified
April 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DART-MSHR-06-29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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