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Sponsored by: |
Menzies School of Health Research |
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Information provided by: | Menzies School of Health Research |
ClinicalTrials.gov Identifier: | NCT00437970 |
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).
Condition | Intervention | Phase |
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Diabetes Mellitus, Type 2 |
Drug: Pioglitazone Drug: Metformin |
Phase IV |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 60 |
Study Start Date: | April 2008 |
Estimated Study Completion Date: | February 2009 |
Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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A: Active Comparator
Arm A- Metformin
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Drug: Metformin
500 mg of Metformin taken orally twice a day
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B: Active Comparator
Arm B- Pioglitazone
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Drug: Pioglitazone
15mg of Pioglitazone taken orally twice a day
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Australia, Northern Territory | |
Menzies School of Health Research | |
Darwin, Northern Territory, Australia, 0810 |
Principal Investigator: | Louise Maple Brown, MBBS PhD FRACP | Menzies School of Health Research |
Responsible Party: | Menzies School of Health Research ( The Director ) |
Study ID Numbers: | DART-MSHR-06-29 |
Study First Received: | February 18, 2007 |
Last Updated: | April 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00437970 History of Changes |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration; Australia: Human Research Ethics Committee; Australia: National Health and Medical Research Council |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Metformin Diabetes Mellitus, Type 2 Diabetes Mellitus |
Endocrine System Diseases Endocrinopathy Glucose Metabolism Disorders Rosiglitazone Metabolic Disorder |
Hypoglycemic Agents Metabolic Diseases Pioglitazone Physiological Effects of Drugs Metformin |
Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Pharmacologic Actions |