A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients With Type 2 Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 245
- 试验地点
- 92
- 主要终点
- Reduction in glycosylated hemoglobin A1c
研究概览
简要总结
A Phase 3b, open-label, randomized, multicenter, efficacy, safety, and tolerability study of ITCA 650 compared to Empagliflozin and to Glimepiride, as add-on therapy to Metformin in patients with Type 2 diabetes.
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
- 否
入选标准
- •Diagnosis of T2D 3 months prior to the Screening Visit.
- •Body mass index (BMI) between ≥25 to ≤45 kg/m2 at the Screening Visit.
- •Glycosylated hemoglobin A1c (HbA1c) ≥7.5 and ≤10.5%.
- •On a stable (3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of ≥1500 mg/day).
排除标准
- •History of type 1 diabetes.
- •Prior participation in a clinical study involving ITCA
- •Treatment with any GLP-1 receptor agonist (eg, liraglutide, exenatide) within 6 months prior to Screening.
- •History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.
- •History or evidence of acute or chronic pancreatitis.
- •History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type
- •Treatment of medications that affect GI motility.
- •History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients.
- •Women that are pregnant, lactating, or planning to become pregnant.
- •Chronic (>10 consecutive days) treatment with systemic corticosteroids within 8 weeks prior to screening.
研究组 & 干预措施
Experimental: Group 3
Glimepiride 1-6 mg/day
干预措施: Glimepiride (oral) (Drug)
Experimental: Group 1
ITCA 650 20/60 mcg/day
干预措施: ITCA 650 20/60 mcg/day (Drug)
Experimental: Group 2
Empagliflozin 10 mg/day and 25 mg/day
干预措施: Empagliflozin (oral) (Drug)
结局指标
主要结局
Reduction in glycosylated hemoglobin A1c
时间窗: Randomization to 69 weeks
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing glycosylated hemoglobin A1c (HbA1c) in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
Reduction in weight
时间窗: Randomization to 69 weeks
To determine whether ITCA 650 is non-inferior either to empagliflozin or to glimepiride in reducing weight in patients with T2D following 65 weeks of treatment and 4 weeks of post treatment follow up.
次要结局
未报告次要终点