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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Active Comparator | Arm A- Metformin |
|
| B | Active Comparator | Arm B- Pioglitazone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pioglitazone | Drug | 15mg of Pioglitazone taken orally twice a day |
| |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c values | second monthly | |
| Weight gain | monthly | |
| Weight distribution | six monthly | |
| Medication side effects | monthly |
| Measure | Description | Time Frame |
|---|---|---|
| Medication compliance | monthly | |
| Side effects | monthly | |
| Lipids |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Louise Maple Brown, MBBS PhD FRACP | Menzies School of Health Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Menzies School of Health Research | Darwin | Northern Territory | 0810 | Australia |
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| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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| Metformin |
| Drug |
500 mg of Metformin taken orally twice a day |
|
| second monthly |
| Endothelial dysfunction. | second monthly |
| D004700 | Endocrine System Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |