NCT01676116已完成3 期
The Efficacy of Insulin Degludec/Liraglutide in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on GLP-1 Receptor Agonist and OAD Therapy (DUAL™ III -GLP-1 Switch)
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
- 438
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
研究概览
简要总结
This trial is conducted in Europe, Oceania and the United States of America (USA).
The aim of the trial is to investigate the efficacy of insulin degludec/liraglutide in controlling glycaemia in adults with type 2 diabetes inadequately controlled on glucagon-like peptide-1 (GLP-1) receptor agonist and OAD therapy.
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
- •Subjects with type 2 diabetes mellitus
- •Glycosylated haemoglobin (HbA1c) 7.0-9.0% (53-75 mmol/mol) (both inclusive)
- •Treatment with daily GLP-1 receptor agonist at maximum dose according to local label (i.e. 1.8 mg once daily (OD) Victoza® (liraglutide) or 10 microgram twice daily (BID) Byetta® (exenatide)) or documented maximum tolerated dose (i.e. 1.2 mg OD Victoza® (liraglutide) or 5 microgram BID Byetta® (exenatide)) in combination with a stable daily dose of metformin (equal to or above 1500 mg or documented maximum tolerated dose) for 90 days or more prior to screening visit (Visit 1)
- •BMI (body mass index) equal to or below 40 kg/m^2
排除标准
- •Any use of oral anti-diabetic drugs (OADs) (except for metformin, pioglitazone and sulphonylurea) for 90 days or less prior to screening visit (Visit 1)
- •Use of any drug (except metformin,pioglitazone, sulphonylurea and GLP-1 receptor agonist) which in the Investigator's opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- •Treatment with any insulin regimen (short term treatment due to intercurrent illness including gestational diabetes is allowed at the discretion of the Investigator)
- •Screening calcitonin equal to or above 50 ng/l
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN2)
- •Cardiovascular disorders defined as: congestive heart failure (New York Heart Association (NYHA) class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the past 52 weeks prior to screening visit (Visit 1) and/or planned coronary, carotid or peripheral artery revascularisation procedures
- •Proliferative retinopathy requiring acute treatment or maculopathy (macular oedema) according to the Investigator's opinion
- •Subjects with a clinically significant, active (during the past 12 months) disease of the gastrointestinal, pulmonary, endocrinological (except for the type 2 diabetes mellitus), neurological, genitourinary or haematological system that in the opinion of the Investigator may confound the results of the trial or pose additional risk in administering trial products
- •History of chronic pancreatitis or idiopathic acute pancreatitis
研究组 & 干预措施
Insulin degludec/liraglutide + OADs
Experimental
干预措施: insulin degludec/liraglutide (Drug)
Liraglutide or exenatide + OADs
Active Comparator
干预措施: liraglutide (Drug)
Liraglutide or exenatide + OADs
Active Comparator
干预措施: exenatide (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2)
时间窗: Week 0, week 26
次要结局
- Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)(Week 26)
- Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)(Week 26)
- Change From Baseline in Body Weight(Week 0, week 26)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)
- Number of Severe or Minor Hypoglycaemic Episodes(After 26 weeks of treatment)
- Number of Adverse Events (AEs)(After 26 weeks of treatment)
- Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D)(Week 0, week 26)
- Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ).(Week 0, week 26)
研究者
研究点 (1)
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