NCT02298192已完成3 期
A Clinical Trial Comparing Efficacy and Safety of Insulin Degludec/Liraglutide (IDegLira) in Subjects With Type 2 Diabetes Mellitus Using Two Different Titration Algorithms
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
- 420
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c
研究概览
简要总结
This trial is conducted in Europe, North America and the United States of America.
The aim of this trial is to compare two different titration algorithms of insulin degludec/liraglutide.
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
- •Type 2 diabetes mellitus
- •Male or female equal to or above 18 years of age
- •HbA1c (glycosylated haemoglobin) 7.0 - 10.0% [53 mmol/mol - 86 mmol/mol] (both inclusive), confirmed by the central laboratory
- •Stable daily treatment with metformin (above or equal to 1500 mg or max tolerated dose) with or without pioglitazone (above orequal to 30 mg) for at least 90 days prior to screening
- •Body Mass Index (BMI) below or equal to 40 kg/m^2
排除标准
- •Current use of any anti-diabetic drugs (except for metformin and pioglitazone) or anticipated change in concomitant medication, which, in the opinion of the investigator, could interfere with the glucose metabolism (e.g. systemic corticosteroids)
- •Previous and / or current treatment with insulin (short term treatment due to intercurrent illness, including gestational diabetes, is allowed at the discretion of the investigator)
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonists, sulpfonylurea, glinides, dipeptidyl peptidase 4 (DPP-4) inhibitors or sodium-glucose co-transporter 2 (SGLT2) inhibitors within 90 days prior to the screening visit
- •Impaired liver function, defined as alanine aminotransferase (ALAT) above or equal to 2.5 times upper normal range (UNR)
- •Impaired renal function defined as serum-creatinine above or equal to 133 micromol/L (above or equal to 1.5 mg/dL) for males and above or equal to 125 micromol/L (above or equal to 1.4 mg/dL) for females, or as defined according to local contraindications for metformin
- •Screening calcitonin above or equal to 50 ng/L
- •Proliferative retinopathy or maculopathy (macular oedema) requiring acute treatment, according to investigator's clinical judgment
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- •History of pancreatitis (acute or chronic)
研究组 & 干预措施
Once weekly titration
Experimental
干预措施: insulin degludec/liraglutide (Drug)
Twice weekly titration
Experimental
干预措施: insulin degludec/liraglutide (Drug)
结局指标
主要结局
Change From Baseline in HbA1c
时间窗: Week 0, week 32
Change in glycosylated haemoglobin A1c (HbA1c) (%) from baseline after 32 weeks of treatment.
次要结局
- Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes(Week 0-32)
- HbA1c Below or Equal to 6.5%(Week 0, week 32)
- HbA1c Below 7.0%(Week 0, week 32)
研究者
研究点 (1)
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