A Phase IIb, Randomized, Double-blind, Placebo-controlled and Open-label Active Comparator Study to Evaluate the Efficacy, Safety, and Tolerability of AZD5004 in Adults With Type 2 Diabetes Mellitus.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 406
- 试验地点
- 98
- 主要终点
- Change in HbA1c
研究概览
简要总结
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.
详细描述
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. The study is planned to be conducted in approximately 15 countries, approximately 90 sites will be involved.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Masking (blinding) applies to patients and investigators involved in AZD5004 and placebo arms, however not in active comparator arm.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 years of age.
- •Diagnosed with T2DM for at least 6 months.
- •HbA1c ≥ 7.0% and ≤ 10.5% 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/m
- •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.
研究组 & 干预措施
Arm 1
Participants will receive xx mg once daily dose of AZD5004
干预措施: AZD5004 (Drug)
Arm 2
Participants will receive xx mg once daily dose of AZD5004
干预措施: AZD5004 (Drug)
Arm 3
Participants will receive xx mg once daily dose of AZD5004
干预措施: AZD5004 (Drug)
Arm 4
Participants will receive xx mg once daily dose of AZD5004
干预措施: AZD5004 (Drug)
Arm 5
Participants will receive xx mg once daily dose of AZD5004
干预措施: AZD5004 (Drug)
Arm 6
Participants will receive xx mg once daily dose of AZD5004
干预措施: AZD5004 (Drug)
Arm 7
Participants will receive once daily dose of Semaglutide as active comparator
干预措施: Semaglutide (Drug)
Arm 8
Participants will receive matching placebo for each AZD5004 arm
干预措施: Placebo (placebo matching AZD5004 film-coated tablet) (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: Baseline to Week 26
To evaluate the effect of AZD5004 versus placebo on glycemic control
次要结局
- Change in fasting glucose(Baseline to Weeks 4, 12, 16 and 26)
- Achievement of HbA1c ≤ 6.5%(Week 26)
- Baseline HbA1c ≥ 7.0% and achieved HbA1c < 7.0%(Week 26)
- Percent change in body weight(Baseline to Week 26)
- Absolute change in body weight(Baseline to Week 26)
- Achievement of ≥ 5%, ≥ 10%, and ≥ 15% weight reduction(Baseline to Week 26)