NCT02420262已完成3 期
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) Versus Basal-bolus Therapy in Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 506
- 试验地点
- 1
- 主要终点
- Change in HbA1c (Glycosylated Haemoglobin)
研究概览
简要总结
This trial is conducted globally. The aim of this trial is to compare efficacy and safety of insulin degludec/liraglutide (IDegLira) versus basal-bolus therapy in combination with metformin in subjects with type 2 diabetes mellitus.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age at least 18 years at the time of signing informed consent
- •Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
- •HbA1c (glycosylated haemoglobin) 7.0-10.0% [53mmol/mol-86mmol/mol] (both inclusive) by central laboratory analysis
- •Current treatment with IGlar (insulin glargine) for at least 90 calendar days prior to screening
- •Stable daily dose of IGlar between 20 units and 50 units (both inclusive) for at least 56 calendar days prior to screening. Individual fluctuations of plus/minus 10% within the 56 calendar days prior to screening are acceptable, however on the day of screening total daily dose should be within the range of 20 units-50 units both inclusive
- •Stable daily dose of metformin (at least 1500 mg or max tolerated dose) for at least 90 calendar days prior to screening
- •Body mass index (BMI) below or equal to 40 kg/m^2
排除标准
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 calendar days before screening
- •Anticipated initiation or change in concomitant medications in excess of 14 calendar days known to affect weight or glucose metabolism, such as weight loss/modifying (e.g.; sibutramine, orlistat, thyroid hormones, corticosteroids)
- •Impaired liver function, defined as alanine aminotransferase (ALT) at least 2.5 times upper limit of normal
- •Renal impairment eGFR (electronic case report form) below 60 mL/min/1.73 m^2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration)
- •Screening calcitonin at least 50 ng/L
- •History of pancreatitis (acute or chronic)
- •Personal or family history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2
研究组 & 干预措施
IDegLira
Experimental
干预措施: insulin degludec/liraglutide (Drug)
IGlar plus IAsp
Active Comparator
干预措施: insulin glargine (Drug)
IGlar plus IAsp
Active Comparator
干预措施: insulin aspart (Drug)
结局指标
主要结局
Change in HbA1c (Glycosylated Haemoglobin)
时间窗: Week 0, Week 26
Change in HbA1c values after 26 weeks of treatment.
次要结局
- Responder for HbA1c Below or Equal to 6.5 %(After 26 weeks of treatment)
- Number of Treatment Emergent Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes.(Weeks 0-26)
- Change in Body Weight(Week 0, Week 26)
- Responder for HbA1c Below 7.0%(After 26 weeks of treatment)
研究者
研究点 (1)
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