NCT01618162已完成3 期
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
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
- 435
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
This trial is conducted in Asia, Europe and the United States of America (USA). The aim of this trial is to investigate the efficacy and safety of insulin degludec/liraglutide in insulin naïve subjects inadequately controlled with SU (sulphonylurea) alone or in combination with metformin. All subjects will continue their pre-trial SU treatment with or without metformin treatment without changing the frequency or dose throughout the trial.
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
- Double (Participant, Investigator)
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
- •HbA1c 7.0-9.0% (53-75 mmol/mol) (both inclusive)
- •Subjects on stable daily dose of sulphonylurea (above or equal to half of the max approved dose according to local label) with or without metformin (above or equal to 1500 mg or max tolerated dose) for at least 90 days prior to screening visit (Visit 1)
- •Body Mass Index (BMI) below or equal to 40 kg/m^2
排除标准
- •Any use of oral anti-diabetic drugs (OADs) (other than SU in monotherapy or in combinationwith metformin) below or equal to 90 days prior to screening visit (Visit 1)
- •Use of any drug (other than SU in monotherapy or in combination with metformin), which in the Investigators opinion could interfere with the blood glucose level (e.g. systemic corticosteroids)
- •Previous treatment with glucagon-like peptide-1 (GLP-1) receptor agonist (e.g. exenatide, liraglutide)
- •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 above or equal to 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 clinical 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 product
- •History of chronic pancreatitis or idiopathic acute pancreatitis
研究组 & 干预措施
Insulin degludec/liraglutide
Experimental
干预措施: insulin degludec/liraglutide (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, Week 26
Change in HbA1c from baseline to 26 weeks.
次要结局
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 26)
- 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)
- Number of Adverse Events (AEs)(After 26 weeks of treatment)
- Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes(After 26 weeks of treatment)
研究者
研究点 (1)
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