Diabetes Mellitus, Type 2
Conditions
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).
Interventions
DRUGPioglitazone
15mg of Pioglitazone taken orally twice a day
DRUGMetformin
500 mg of Metformin taken orally twice a day
Sponsors
Menzies School of Health Research
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Medication side effects | monthly |
| HbA1c values | second monthly |
| Weight gain | monthly |
| Weight distribution | six monthly |
Secondary
| Measure | Time frame |
|---|---|
| Medication compliance | monthly |
| Side effects | monthly |
| Lipids | second monthly |
| Endothelial dysfunction. | second monthly |
Countries
Australia
Outcome results
None listed