NCT02911948已完成3 期
A Double-blinded Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec Both in Combination With Metformin in Japanese Subjects With Type 2 Diabetes Mellitus Inadequately Controlled With Basal or Pre-mix/Combination Insulin Therapy and Oral Anti-diabetic Drugs
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
- 210
- 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. The aim of this trial is to compare the efficacy and safety of insulin degludec/liraglutide and insulin degludec both in combination with metformin in Japanese subjects with type 2 diabetes mellitus inadequately controlled with basal or pre-mix/combination insulin therapy and oral anti-diabetic drugs.
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
- 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
- •T2DM (type 2 diabetes mellitus) subjects (diagnosed clinically) for at least 6 months prior to screening
- •HbA1c (glycosylated haemoglobin) 7.5-11.0 per cent [58 mmol/mol-97 mmol/mol] (both inclusive) by central laboratory analysis
- •Subjects on stable daily insulin doses for at least 60 days prior to screening administered once or twice daily, either as basal insulin (e.g. IDeg, insulin glargine, insulin detemir, NPH insulin) or pre-mix/combination insulin (e.g. biphasic insulin aspart, insulin degludec/insulin aspart). Total daily insulin dose in the previous 60 days should be within 20-50 units, both inclusive, and on the day of screening, but fluctuations of plus/minus 20 per cent within the 60 days prior to screening are acceptable. The specified insulin treatment should be administered in combination with a stable daily dose of metformin within current approved Japanese label for at least 60 days prior to screening - additionally, the anti-diabetic treatment can be with or without a stable daily dose of one of the following other OADs (oral anti-diabetic drug): SU (sulfonylureas), glinides, alpha-glucosidase inhibitor, SGLT2i (sodium glucose co-transporter 2 inhibitor) or TZD (thiazolidinedione) within current approved Japanese label for at least 60 days prior to screening
- •Body Mass Index (BMI) equal or above 23 kg/m^2
排除标准
- •Receipt of any investigational medicinal product (IMP) within 30 days before screening
- •Use of any anti-diabetic drug in a period of 60 days before screening (except premix/ combination or basal insulin, metformin, SU, glinides, α-GI, SGLT2i, or TZD) or anticipated change in concomitant medication, which in the investigators opinion could interfere with glucose metabolism (e.g. systemic corticosteroids or bolus insulin)
- •Treatment with glucagon-like peptide-1 (GLP-1) receptor agonist during the last 60 days prior to screening and furthermore, the discontinuation of GLP-1 receptor agonist at any point in time must not have been due to safety concerns, tolerability issues or lack of efficacy, as judged by the investigator
- •Treatment with dipetidyl peptidase-4 (DPP-4) inhibitors during the last 60 days prior to screening - Impaired liver function, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) equal or above 2.5 times upper limit of normal
- •Renal impairment estimated Glomerular Filtration Rate (eGFR) below 60 mL/min/1.73m^2 as per Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI)
- •Screening calcitonin equal 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
Experimental
干预措施: Insulin degludec/liraglutide (Drug)
Insulin degludec
Active Comparator
干预措施: Insulin degludec (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: week 0, week 26
Change from baseline (week 0) in HbA1c after 26 weeks of treatment.
次要结局
- Change in Body Weight(week 0, week 26)
- Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain(After 26 weeks)
- Responder (Yes/no): HbA1c Less Than 7.0% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 26 weeks)
- Responder (Yes/no): HbA1c Less Than 7.0%(After 26 weeks)
- Number of Treatment Emergent Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes(During 26 weeks of treatment)
- 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 26 weeks)
- Change in Pulse(Week 0, week 26)
- Responder (Yes/no): HbA1c Less Than or Equal to 6.5%(After 26 weeks)
- Change in Fasting Plasma Glucose (FPG)(week 0, week 26)
- Daily Insulin Dose(After 26 weeks)
- Change in Waist Circumference(week 0, week 26)
- Number of Treatment Emergent Adverse Events (TEAE)(During 26 weeks of treatment)
- Responder (Yes/no): HbA1c Less Than or Equal to 6.5% Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 26 weeks)
- Change in SMBG 9-point Profile: Mean of the 9-point Profile(Week 0, week 26)
- Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: Diabetes Therapy-Related Quality of Life (DTR-QOL)Questionnaire(week 0, week 26)
- Change From Baseline in Patient Reported Outcomes (PROs) of Treatment: EuroQol-5D (EQ-5D-5L) Questionnaire(week 0, week 26)
- Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain(After 26 weeks)
- Responder (Yes/no): HbA1c Less Than or Equal to 6.5% and Without Weight Gain and Without Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment(After 26 weeks)
- Change in Blood Pressure (Systolic and Diastolic)(week 0, week 26)
- Self-measured Blood Glucose (SMBG) 9-point Profile (Individual Points in the Profile)(After 26 weeks)
- Change in SMBG 9-point Profile: Mean of Postprandial Plasma Glucose Increments (From Before Meal to 90 Minutes After Breakfast, Lunch and Dinner)(Week 0, week 26)
- Fasting Lipid Profile(Week 0, week 26)
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(During 26 weeks of treatment)
- Number of Treatment Emergent Hypoglycaemic Episodes According to American Diabetes Association (ADA) Definition(During 26 weeks of treatment)
- Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(During 26 weeks of treatment)
- Change in Clinical Evaluation: Fundoscopy or Fundus Photography(Screening (week -2 to week 0), week 26)
- Change in Clinical Evaluation: Electrocardiogram (ECG)(Screening (week -2 to week 0), week 26)
研究者
研究点 (1)
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