jRCT2031240411招募中不适用
This is a Phase IIb, randomised, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy, safety and tolerability of AZD5004 in adults with type 2 diabetes mellitus, compared to placebo and active comparator. (SOLSTICE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 28
- 主要终点
- Change in HbA1c at baseline to Week 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Adults 18 years of age or more.
- •Diagnosed with T2DM for at least 6 months.
- •HbA1c 7.0% or more and 10.5% or less managed with diet and exercise alone or with a stable dose of metformin or an SGLT2 inhibitor for at least one month prior to screening.
- •Body mass index of 23 kg/m2 or more.
- •Stable self-reported body weight for 3 months prior to randomization (+/- 5% body weight change).
排除标准
- •Type 1 diabetes mellitus, secondary forms of diabetes or history of ketoacidosis or hyperosmolar coma.
- •History of proliferative diabetic retinopathy, diabetic maculopathy, or severe non-proliferative diabetic retinopathy that required immediate treatment.
- •Have had more than one episode of severe hypoglycemia within 6 months prior to screening, or has a history of hypoglycemia unawareness or poor recognition of hypoglycemic symptoms.
- •Received medication for weight loss within the last 3 months prior to screening.
- •Clinically significant inflammatory bowel disease, gastroparesis, severe disease or surgery affecting the upper GI tract.
- •Previous or planned (within study period) bariatric surgery or fitting of a weight loss device (eg, gastric balloon or duodenal barrier).
- •History of acute or chronic pancreatitis.
结局指标
主要结局
Change in HbA1c at baseline to Week 26
时间窗: baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on glycemic control
次要结局
未报告次要终点
研究者
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