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
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- HbA1c values
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- 未提供
研究组 & 干预措施
A
Arm A- Metformin
干预措施: Metformin (Drug)
B
Arm B- Pioglitazone
干预措施: Pioglitazone (Drug)
结局指标
主要结局
HbA1c values
时间窗: second monthly
Weight gain
时间窗: monthly
Weight distribution
时间窗: six monthly
Medication side effects
时间窗: monthly
次要结局
- Medication compliance(monthly)
- Side effects(monthly)
- Lipids(second monthly)
- Endothelial dysfunction.(second monthly)