NCT02607306已完成3 期
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Japanese 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
- 819
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide, insulin degludec and liraglutide in Japanese 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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Japanese subjects, age at least 20 years at the time of signing informed consent
- •Type 2 diabetes subjects (diagnosed clinically) at least 6 months prior to screening
- •HbA1c (glycosylated haemoglobin) 7.0-11.0 % (both inclusive) by central laboratory analysis, with the aim of a median of 8.3%. When approximately 50% of the randomised subjects have a HbA1c above 8.3%, the remaining subjects randomised must have a HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have a HbA1c below or equal to 8.3%, the remaining subjects randomised must have a HbA1c above 8.3%
- •Body-mass index (BMI) above or equal to 20 kg/m^2
- •Subjects on stable therapy with one OAD (defined as unchanged medication and unchanged dose) for at least 60 days (metformin, a-GI, TZD, SU, SGLT2i or glinide) prior to screening according to approved Japanese labelling
排除标准
- •Previous treatment with insulin (except for short-term treatment in connection with intercurrent illness including gestational diabetes)
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 60 days before screening
- •Anticipated initiation or change in concomitant medications in excess of 14 days known to affect weight or glucose metabolism
- •Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal to or above 2.5 times upper limit of normal
- •Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60mL/min/1.73m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- •Screening calcitonin equal to or above 50 ng/L
- •History of pancreatitis (acute or chronic)
- •Personal or family history of medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia type 2 (MEN 2)
- •Subjects presently classified as being in New York Heart Association (NYHA) Class IV
研究组 & 干预措施
Insulin degludec/liraglutide OD
Experimental
干预措施: insulin degludec/liraglutide (Drug)
Insulin degludec OD
Active Comparator
干预措施: insulin degludec (Drug)
Liraglutide OD
Active Comparator
干预措施: liraglutide (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Non-inferiority of IDegLira vs IDeg and Superiority of IDegLira vs Lira
时间窗: Week 0, Week 52
Change from baseline (week 0) in HbA1c after 52 weeks of treatment was measured. Statistical analyses were performed to test the hypotheses: non-inferiority of IDegLira vs. IDeg and superiority of IDegLira vs. Liraglutide (Lira).
次要结局
- Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes(Weeks 0-52)
- Change From Baseline in HbA1c (Glycosylated Haemoglobin) Tested for Superiority of IDegLira vs IDeg(Week 0, Week 52)
- Insulin Dose(After 52 weeks of treatment)
- Change From Baseline in Body Weight (kg)(Week 0, Week 52)
- Responder (Yes/no): HbA1c Less Than 7.0%(After 52 weeks of treatment)
- Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 52 weeks of treatment)
- Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero(After 52 weeks of treatment)
- Responder (Yes/no): HbA1c Less Than 6.5% and Change in Body Weight From Baseline Below or Equal to Zero and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 52 weeks of treatment)
- Fasting C-peptide as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Proinsulin as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, Week 52)
- Responder (Yes/no): HbA1c Less Than 7.0% and Change in Body Weight From Baseline Below or Equal to Zero(After 52 weeks of treatment)
- Responder (Yes/no): HbA1c Less Than 6.5%(After 52 weeks of treatment)
- Change in Waist Circumference(Week 0, Week 52)
- Change in SMBG 9-point Profile - Mean of the 9-point Profile(Week 0, week 52)
- Low Density Lipoprotein (LDL) Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- High Density Lipoprotein (HDL) Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Very Low Density Lipoprotein (VLDL) Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Triglycerides as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes(0-52 weeks)
- Anti-drug Antibodies: Anti-insulin Degludec Antibodies(at week 52)
- Change in Clinical Evaluation: Pulse(Week 0, week 52)
- Responder (Yes/no): HbA1c Less Than 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.(After 52 weeks of treatment)
- Change in Blood Pressure (Systolic and Diastolic)(Week 0, Week 52)
- Change in SMBG 9-point Profile - Mean of Postprandial Increments (From Before Meal to 90 Min After for Breakfast, Lunch and Dinner)(Week 0, week 52)
- Free Fatty Acids as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Change in Clinical Evaluation: Fundoscopy or Fundus Photography(at screening (week -2 to week 0), at week 52)
- Responder (Yes/no): HbA1c Less Than 6.5% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment.(After 52 weeks of treatment)
- Self-Measured Blood Glucose (SMBG) 9-point Profile: 9-point Profile (Individual Points in the Profile)(After 52 weeks of the treatment)
- Total Cholesterol as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Fasting Human Insulin as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Fasting Glucagon as a Ratio to Baseline at 52 Weeks(After 52 weeks of treatment)
- Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(0-52 weeks)
- Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition(0-52 weeks)
- Anti-drug Antibodies: Number of Participants Positive or Negative for Anti-liraglutide Antibodies(at week 52)
- Change in Clinical Evaluation: Electrocardiogram (ECG)(at screening (week -2 to week 0), at week 52)
- Serum Concentrations of Insulin Degludec(Weeks 2, 8, 16, 26, 44, 52)
- Plasma Concentrations of Liraglutide(Weeks 2, 8, 16, 26, 44, 52)
- Number of Treatment Emergent Adverse Events (TEAEs)(0-52 weeks)
研究者
研究点 (1)
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