Medication in Early Diabetes (MED) Study
- Registration Number
- NCT00437970
- Lead Sponsor
- Menzies School of Health Research
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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)
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Metformin Arm A- Metformin B Pioglitazone Arm B- Pioglitazone
- Primary Outcome Measures
Name Time Method Medication side effects monthly HbA1c values second monthly Weight gain monthly Weight distribution six monthly
- Secondary Outcome Measures
Name Time Method Medication compliance monthly Side effects monthly Lipids second monthly Endothelial dysfunction. second monthly
Trial Locations
- Locations (1)
Menzies School of Health Research
🇦🇺Darwin, Northern Territory, Australia