NCT03172494已完成3 期
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec, and Liraglutide in Chinese Subjects With Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drugs (OADs)
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
- 720
- 试验地点
- 1
- 主要终点
- Change in HbA1c
研究概览
简要总结
This trial is conducted in Asia. The aim of this trial is to confirm the efficacy of insulin degludec/liraglutide in controlling glycaemia in Chinese subjects with type 2 diabetes mellitus inadequately controlled on oral antidiabetic agents
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
- •Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
- •Type 2 diabetes mellitus (clinically diagnosed)
- •Male or female, age at least 18 years at the time of signing informed consent
- •HbA1c 7.0-10.0 % (both inclusive) by central laboratory analysis, with the aim of a median of8.3%. When approximately 50% of the randomised subjects have an HbA1c above 8.3%, the remaining subjects randomised must have an HbA1c below or equal to 8.3%; or when approximately 50% of the randomised subjects have an HbA1c below or equal to 8.3%, the remaining subjects randomised must have an HbA1c above 8.3%
- •Current treatment for at least 90 calendar days prior to screening with metformin plus/minus one other OAD: α-glucosidase inhibitors, sulphonylureas, glinides or thiazolidinediones. For above or equal to 60 calendar days prior to screening subjects should be on a stable dose of:
- •Metformin (above or equal to 1500 mg or max tolerated dose) or
- •Metformin (above or equal to 1500 mg or max tolerated dose) and sulphonylureas (above or equal to half of the max approved dose according to local label) or
- •Metformin (above or equal to 1500 mg or max tolerated dose) and glinides (above or equal to half of the max approved dose according to local label) or
- •Metformin (above or equal to 1500 mg or max tolerated dose) and α-glucosidase inhibitors (above or equal to half of the max approved dose according to local label) or
- •Metformin (above or equal to 1500 mg or max tolerated dose) and thiazolidinediones (above or equal to half of the max approved dose according to local label)
排除标准
- •Treatment with insulin (except for short-term treatment at the discretion of the investigator)
- •Treatment with glucagon-like-peptide-1 receptor agonists or dipeptidyl-peptidase-4 inhibitors within 90 days prior to screening
- •Impaired liver function, defined as alanine aminotransferase above or equal to 2.5 times upper normal range
- •Impaired renal function defined as serum-creatinine above or equal to 133 μmol/L for males and above or equal to 125 μmol/L for females, or as defined according to local contraindications for metformin
- •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)
- •Cardiac disorder defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, cerebral stroke and/or myocardial infarction within the last 12 months prior to screening and/or planned coronary, carotid or peripheral artery revascularisation procedures
- •Severe uncontrolled treated or untreated hypertension (systolic blood pressure above or equal to 180 mmHg or diastolic blood pressure above or equal to 100 mmHg
- •Proliferative retinopathy or maculopathy (macular oedema), requiring acute treatment
- •History of pancreatitis (acute or chronic)
研究组 & 干预措施
Liraglutide
Active Comparator
干预措施: Liraglutide (Drug)
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 HbA1c
时间窗: Week 0, week 26
Change in HbA1c from baseline (week 0) after 26 weeks of treatment is presented.
次要结局
- Participants Who Achieved HbA1c < 7.0% Without Severe or BG Confirmed Episodes, and Change From Baseline in Body Weight Below or Equal to Zero.(Week 26)
- Change in Waist Circumferance(Week 0, week 26)
- Change in Mean of 9-point SMPG Profile(Week 0, week 26)
- Change in Fasting High Density Lipoprotein (HDL) Cholesterol- Ratio to Baseline(Week 0, week 26)
- Change in Mean Post-prandial Plasma Glucose (PG) Increments(Week 0, week 26)
- Change in Fasting Total Cholesterol - Ratio to Baseline(Week 0, week 26)
- Change in Fasting Very Low-density Lipoprotein (VLDL) Cholesterol- Ratio to Baseline(Week 0, week 26)
- Change in Fasting Human Insulin - Ratio to Baseline(Week 0, week 26)
- Change in HOMA-B (Beta Cell Function)- Ratio to Baseline(Week 0, week 26)
- Change in Fasting Glucagon - Ratio to Baseline(Week 0, week 26)
- Change in Fasting Triglycerides - Ratio to Baseline.(Week 0, week 26)
- Change in Fasting Free Fatty Acid - Ratio to Baseline(Week 0, week 26)
- Change in Fasting Low Density Lipoprotein (LDL) Cholesterol- Ratio to Baseline(Week 0, week 26)
- Number of Treatment-emergent Adverse Events (TEAE)(Weeks 0-26)
- Number of Treatment Emergent Nocturnal Severe or BG Confirmed Hypoglycaemic Episodes.(Weeks 0-26)
- Number of Treatment Emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes.(Weeks 0-26)
- Number of Treatment Emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes(Weeks 0-26)
- Number of Treatment Emergent Hypoglycaemic Episodes According to ADA Definition(Weeks 0-26)
- Change in Physical Examination(Week -2, week 26)
- Eye Examination(Week -2, Week 26)
- Change in Electrocardiogram (ECG)(Week -2, week 26)
- Change in Pulse(Week 0, week 26)
- Change in Blood Pressure (Systolic and Diastolic Blood Pressure)(Week 0, week 26)
- Change in Biochemistry Parameters: Alkaline Phosphatase, Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Kinase, Amalyse, Lipase, Creatiine Kinase Serum(Week 0, week 26)
- Change in Biochemistry Parameters: Calcium Serum (Total), Calcium Corrected Serum, Potassium Serum, Sodium Serum, Urea Serum(Week 0, week 26)
- Change in Biochemistry Parameters: Total Bilirubin Serum, Creatinine Serum(Week 0, week 26)
- Change in Biochemistry Parameters (Albumin Serum, Total Protein)(Week 0, week 26)
- Change in Haematological Parameter: Erythrocytes Blood(Week 0, week 26)
- Change in Haematological Parameter: Haematocrits(Week 0, week 26)
- Change in Haemotological Parameter- Eosinophils(Week 0, week 26)
- Change in Haematological Parameter - Neutrophils(Week 0, week 26)
- Change in Haematological Parameter: Basophils(Week 0, week 26)
- Change in Haemotological Parameter- Monocytes(Week 0, week 26)
- Change in Haematological Parameter - Lymphocytes(Week 0, week 26)
- Change in Haematology: Haemoglobin Blood(Week 0, week 26)
- Change in Haematologcal Parameter: Leukocytes(Week 0, week 26)
- Change in Haematological Parameter: Thrombocytes(Week 0, week 26)
- Change in Calcitonin(Week 0, week 26)
- Urinalysis (Protein, Glucose, Erythrocytes and Ketones)(Week 0, week 26)
- Occurence of Anti-insulin Degludec Specific Antibodies(Week 27)
- Occurence of Antibodies Cross-reacting to Human Insulin(Week 27)
- Occurence of Total Insulin Antibodies(Week 27)
- Occurence of Anti-liraglutide Antibodies(Week 27)
- Occurence of Antibodies Cross-reacting to Native Glucagon-like Peptide (GLP-1)(Week 27)
- Occurence of Neutralising Liraglutide Antibodies(Week 27)
- Occurence of Neutralising Antibodies Cross-reacting to Native GLP-1(Week 27)
- Serum Concentrations of Insulin Degludec(Week 0, week 26)
- Plasma Concentration of Liraglutide(Week 0, week 26)
- Participants Who Achieved HbA1c < 7.0%, American Diabetes Association (ADA) Target (Yes/no)(Week 26)
- Participants Who Achieved HbA1c < 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes(Week 26)
- Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Episodes and Change From Baseline in Body Weight Below or Equal to Zero.(Week 26)
- Change in Fasting Plasma Glucose (FPG)(Week 0, week 26)
- Participants Who Achieved HbA1c ≤ 6.5%, International Diabetes Federation (IDF) Target (Yes/no)(Week 26)
- Participants Who Achieved HbA1c ≤ 6.5% and Change From Baseline in Body Weight Below or Equal to Zero(Week 26)
- Change in Body Weight(Week 0, week 26)
- Number of Treatment Emergent Severe or BG Confirmed Hypoglycaemic Episodes(Weeks 0-26)
- Insulin Dose(Week 26)
- Participants Who Achieved HbA1c <7.0% and Change in Body Weight From Baseline Below or Equal to Zero(Week 26)
- Participants Who Achieved HbA1c ≤ 6.5% Without Severe or BG Confirmed Hypoglycaemic Episodes(Week 26)
- 9-point SMPG Profile(Week 26)
- Change in Fasting C-peptide - Ratio to Baseline(Week 0, week 26)
研究者
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