NCT02505334已完成3 期
A Trial Comparing the Efficacy and Safety of Liraglutide 1.8 mg/Day to Liraglutide 0.9 mg/Day in Japanese Subjects With Type 2 Diabetes Mellitus
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 635
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
研究概览
简要总结
This trial is conducted in Asia. The aim of the trial is to compare the efficacy and safety of liraglutide 1.8 mg/day to liraglutide 0.9 mg/day 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 at least 20 years of age at the time of informed consent
- •Type 2 diabetes subjects (diagnosed clinically) for at least 6 months prior to screening
- •HbA1c 7.5-10.0% [58 mmol/mol-86 mmol/mol] (both inclusive)
- •Subjects on stable therapy with one OAD (oral antidiabetic drug) (stable therapy is defined as unchanged medication and unchanged dose) for for at least 60 days before screening according to approved Japanese labelling
排除标准
- •Treatment with insulin within 12 weeks prior to screening
- •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
- •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
- •Within the past 180 days any of the following: myocardial infarction, stroke or hospitalisation for unstable angina and/or transient ischemic attack
- •Diagnosis of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer, polyps and in-situ carcinomas)
- •Any condition which, in the opinion of the investigator might jeopardise subject's safety or compliance with the protocol
研究组 & 干预措施
Liraglutide 1.8 mg
Experimental
The total trial duration for the 1.8 mg/day treatment arm will be approximately 67 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week main treatment period, a safety extension period of 26 weeks and a follow-up visit.
干预措施: liraglutide (Drug)
Liraglutide 0.9 mg
Active Comparator
The total trial duration for the 0.9 mg/day treatment arm will be approximately 41 weeks, consisting of 2 weeks screening period, a 12 weeks run-in period, a 26-week treatment period, and a follow-up visit.
干预措施: liraglutide (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c) (Week 26)
时间窗: Week 0, Week 26
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated after 26 weeks of treatment. The change from baseline in the response after 26 weeks of treatment is analysed using an analysis of covariance (ANCOVA) model with treatment as a fixed effect and baseline response as a covariate.
次要结局
- Change in HbA1c (Week 52)(Week 0, Week 52)
- Responder for HbA1c Below 7.0% (53 mmol/Mol)(Week 26 and Week 52)
- Responder for HbA1c Below or Equal to 6.5% (48 mmol/Mol)(Week 26 and Week 52)
- Responder for HbA1c Below 7.0% Without Weight Gain(Week 26 and Week 52)
- Change in Self-Measured Blood Glucose (SMBG) 7-point Profile: 7-point Profile (Individual Points in the Profile)(Week 0 and Week 26 and Week 52)
- Responder for HbA1c Below 7.0% Without Treatment Emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes(Week 26 and Week 52)
- Change in SMBG 7-point Profile: Mean of 7-point Profile(Week 0, Week 26, Week 52)
- Change in SMBG 7-point Profile: Mean of Postprandial Increments (From Before Meal to 90 Minutes After for Breakfast, Lunch and Dinner)(Week 0, Week 26, Week 52)
- Change in Fasting Plasma Glucose (FPG)(Week 0, Week 26, Week 52)
- Change in Waist Circumference(Week 0, Week 26, Week 52)
- Change in Body Weight(Week 0, Week 26, Week 52)
- Change in Body Mass Index (BMI)(Week 0, Week 26, Week 52)
- Change in Blood Pressure (Systolic and Diastolic)(Week 0, Week 26, Week 52)
- Fasting C-peptide(Week 26 and Week 52)
- Fasting Insulin(Week 26 and Week 52)
- Fasting Glucagon(Week 26 and Week 52)
- Proinsulin(Week 26 and Week 52)
- Proinsulin/Insulin(Week 26 and Week 52)
- Homeostasis Model Assessment of Beta-cell Function (HOMA-B)(Week 26 and Week 52)
- Homeostasis Model Assessment as an Index of Insulin Resistance (HOMA-IR)(Week 26 and Week 52)
- Total Cholesterol(Week 26 and Week 52)
- Low Density Lipoprotein (LDL) Cholesterol(Week 26 and Week 52)
- High Density Lipoprotein (HDL) Cholesterol(Week 26 and Week 52)
- Very Low Density Lipoprotein (VLDL) Cholesterol(Week 26 and Week 52)
- Triglycerides(Week 26 and Week 52)
- Free Fatty Acids(Week 26 and Week 52)
- Number of Treatment Emergent Adverse Events(Weeks 0-26 and Weeks 0-52)
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-26 and Weeks 0-52)
- Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-26 and Weeks 0-52)
- Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition(Weeks 0-26 and Weeks 0-52)
- Change in Pulse(Week 0, Week 26, Week 52)
- Change in Physical Examination(Week 0 and Week 26 and Week 52)
- Change in Eye Examination(Week 0 and Week 26 and Week 52)
- Change in Electrocardiogram (ECG)(Week 0 and Week 26 and Week 52)
- Change in Biochemistry: Creatinine(Week 0, Week 26, Week 52)
- Change in Biochemistry: eGFR(Week 0, Week 26, Week 52)
- Change in Biochemistry: Alanine Aminotransferase(Week 0, Week 26, Week 52)
- Change in Biochemistry: Aspartate Aminotransferase(Week 0, Week 26, Week 52)
- Change in Biochemistry: Alkaline Phosphatase(Week 0, Week 26, Week 52)
- Change in Biochemistry: Sodium(Week 0, Week 26, Week 52)
- Change in Biochemistry: Potassium(Week 0, Week 26, Week 52)
- Change in Biochemistry: Albumin(Week 0, Week 26, Week 52)
- Change in Biochemistry: Total Bilirubin(Week 0, Week 26, Week 52)
- Change in Biochemistry: Urea(Week 0, Week 26, Week 52)
- Change in Biochemistry: Creatine Kinase(Week 0, Week 26, Week 52)
- Change in Biochemistry: Calcium(Week 0, Week 26, Week 52)
- Change in Biochemistry: Albumin Corrected Calcium(Week 0, Week 26, Week 52)
- Change in Biochemistry: Amylase(Week 0, Week 26, Week 52)
- Change in Biochemistry: Lipase(Week 0, Week 26, Week 52)
- Change in Haematology: Haemoglobin(Week 0, Week 26, Week 52)
- Change in Haematology: Haematocrit(Week 0, Week 26, Week 52)
- Change in Haematology: Thrombocytes(Week 0, Week 26 and Week 52)
- Change in Haematology: Erythrocytes(Week 0, Week 26 and Week 52)
- Change in Haematology: Eosinophils(Week 0, Week 26 and Week 52)
- Change in Haematology: Leukocytes(Week 0, Week 26 and Week 52)
- Change in Haematology: Basophils(Week 0, Week 26 and Week 52)
- Change in Haematology: Monocytes(Week 0, Week 26 and Week 52)
- Change in Haematology: Lymphocytes(Week 0, Week 26 and Week 52)
- Change in Calcitonin(Week 0 and Week 26 and Week 52)
- Change in Haematology: Neutrophils(Week 0, Week 26 and Week 52)
研究者
研究点 (1)
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