NCT02638805已完成3 期
An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide
Intarcia Therapeutics34 个研究点 分布在 1 个国家目标入组 136 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 136
- 试验地点
- 34
- 主要终点
- Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
研究概览
简要总结
A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.
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 type 2 diabetes ≥ 3 months.
- •Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.
- •HbA1c ≤9.5%.
- •Stable body weight ≥ 3 months.
- •Body mass index (BMI) ≥25 to ≤45 kg per meter squared.
- •Calcitonin <50 ng/L (50 pg/mL) at the Screening Visit.
排除标准
- •History of type 1 diabetes.
- •Recent use or of anti-diabetic medications other than liraglutide or metformin.
- •History of significant/severe nausea and/or vomiting due to liraglutide.
- •Significant symptomatic hyperglycemia.
- •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 liver disease.
- •History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type
- •Poor thyroid, liver, or renal function.
- •Serum creatinine levels >1.5mg/dL (132 μmol/L) for male patients, or >1.4 mg/dL (123 μmol/L) for female patients.
- •Weight loss surgery or requires weight loss medications.
- •History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).
- •History of active alcohol or substance abuse.
- •Treatment with medications that affect GI motility.
- •History of hypersensitivity to exenatide or liraglutide.
- •Women that are pregnant, lactating, or planning to become pregnant.
研究组 & 干预措施
Group 1
Experimental
ITCA 650 20/60 mcg/day
干预措施: ITCA 650 Osmotic Mini Pump 20/60 mcg/day (Drug)
Group 1
Experimental
ITCA 650 20/60 mcg/day
干预措施: Metformin (Drug)
Group 1
Experimental
ITCA 650 20/60 mcg/day
干预措施: Liraglutide (Drug)
Group 2
Experimental
ITCA 650 60 mcg/day
干预措施: ITCA 650 Osmotic Mini Pump 60 mcg/day (Drug)
Group 2
Experimental
ITCA 650 60 mcg/day
干预措施: Metformin (Drug)
Group 2
Experimental
ITCA 650 60 mcg/day
干预措施: Liraglutide (Drug)
结局指标
主要结局
Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting
时间窗: From Randomization to 34 weeks
Number (percentage) and severity of treatment-emergent AEs (TEAEs) of nausea and/or vomiting over the 26-week treatment period; treatment discontinuation for nausea and/or vomiting; and pattern of nausea and/or vomiting over time.
次要结局
- Incidence of hypoglycemia(From Randomization to 34 weeks)
- Number (percentage) and severity of all treatment-emergent adverse events(From Randomization to 34 weeks)
- Change in percentage of glycosylated hemoglobin (HbA1c) in the blood(From baseline to Week 26)
- Change in body weight(from baseline to Week 26)
研究者
研究点 (34)
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