Study Stopped
Unable to secure supply of the study medication
Medication in Early Diabetes (MED) Study
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
1 other identifier
interventional
N/A
1 country
1
Brief 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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Apr 2008
Shorter than P25 for phase_4 diabetes-mellitus-type-2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 18, 2007
CompletedFirst Posted
Study publicly available on registry
February 21, 2007
CompletedStudy Start
First participant enrolled
April 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2009
CompletedMay 27, 2016
April 1, 2009
9 months
February 18, 2007
May 26, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
HbA1c values
second monthly
Weight gain
monthly
Weight distribution
six monthly
Medication side effects
monthly
Secondary Outcomes (4)
Medication compliance
monthly
Side effects
monthly
Lipids
second monthly
Endothelial dysfunction.
second monthly
Study Arms (2)
A
ACTIVE COMPARATORArm A- Metformin
B
ACTIVE COMPARATORArm B- Pioglitazone
Interventions
Eligibility Criteria
You may qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Menzies School of Health Research
Darwin, Northern Territory, 0810, Australia
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Louise Maple Brown, MBBS PhD FRACP
Menzies School of Health Research
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 18, 2007
First Posted
February 21, 2007
Study Start
April 1, 2008
Primary Completion
January 1, 2009
Study Completion
February 1, 2009
Last Updated
May 27, 2016
Record last verified: 2009-04