ACTRN12622000152729已完成未知
A pilot study to test the safety, tolerability and feasibility of dulaglutide during a low-energy diet in type 2 diabetes
适应症
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 19
研究概览
简要总结
In total, we enrolled 19 people in this pilot study. 10 were men and 9 were woman. There were 10 Pasifika participants, 5 Maori, 2 Pakeha and 2 of other ethnicities. 16 people completed the full 12 week diet. 1 person stopped the diet but came to the remaining trial visits and 2 people dropped out of the trial. Participants lost an average of 9.5kg and their HbA1c fell from an average of 70.7 mmol/mol to 54.9 mmol/mol. Mild side effects were common but tended to improve as the trial went on. The most common side effects were nausea and headaches. There was one serious side effect which was someone losing consciousness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 20 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Able and willing to give written informed consent
- •Men and women aged 20-65 years, all ethnicities
- •T2DM of duration 0-6 years
- •Eligible for funded dulaglutide under New Zealand PHARMAC special authority criteria
- •Body mass index (BMI)>27 kg/m2 and <45 kg/m2
排除标准
- •Most recent HbA1c greater than 108mmol/mol (12%)
- •Most recent eGFR less than 30 mls/min/1.732
- •Substance abuse
- •Known cancer
- •Myocardial infarction or stroke within previous 6 months
- •Learning difficulties
- •Current treatment with anti-obesity drugs
- •Diagnosed eating disorder or purging
- •Pregnant or considering pregnancy
- •People who have required hospitalisation for depression or are on antipsychotic drugs
- •People currently participating in another clinical research trial
- •People taking a monoamine oxidase inhibitor
研究者
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