Medication in Early Diabetes (MED) Study
NCT00437970 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL
Last updated 2016-05-27
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).
Conditions
- Diabetes Mellitus, Type 2
Interventions
- DRUG
-
Pioglitazone
15mg of Pioglitazone taken orally twice a day
- DRUG
-
500 mg of Metformin taken orally twice a day
Sponsors & Collaborators
-
Menzies School of Health Research
lead OTHER
Principal Investigators
-
Louise Maple Brown, MBBS PhD FRACP · Menzies School of Health Research
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-04-30
- Primary Completion
- 2009-01-31
- Completion
- 2009-02-28
Countries
- Australia
Study Locations
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