NCT03268005已完成3 期
Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Type 2 Diabetes (Onset® 9)
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
- 1,264
- 试验地点
- 1
- 主要终点
- Change in Glycosylated Haemoglobin (HbA1c)
研究概览
简要总结
The study compares 2 medicines for type 2 diabetes: fast-acting insulin aspart (a new medicine) and NovoRapid®/NovoLog® (a medicine doctors can already prescribe). Fast-acting insulin aspart will be tested to see how well it works and if it is safe. Participants will get either fast-acting insulin aspart or NovoRapid®/ NovoLog® - which treatment you get is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day (all insulins will be provided in pens). The study will last for about 8 months (34 weeks).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Sponsor staff involved in the clinical trial is masked according to company standard procedures.
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
- •Male or female, age equal to or above 18 years at the time of signing informed consent. - Diagnosed with type 2 diabetes mellitus for 10 years or longer prior to screening (Visit 1). - Treated with a basal-bolus insulin regimen for 1 year or longer prior to the day of screening (Visit 1). A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin analogue taken with meals at least 3 times daily. Treatment with premixed insulin or soluble insulin combination is not considered a basal-bolus regimen. - Treated with or without oral antidiabetic drugs including extended release formulations. - HbA1c 7.0-10.0% (both inclusive) as assessed by central laboratory at screening (Visit 1).
排除标准
- •Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening (Visit 1). - Subjects presently classified as being in New York Heart Association (NYHA) Class IV. - Planned coronary, carotid or peripheral artery revascularisation known on the day of screening (Visit 1). - Treatment with injectable GLP-1 receptor agonists in a period of 90 days prior to screening (Visit 1). - Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
研究组 & 干预措施
Faster aspart + insulin degludec with or without metformin
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Faster aspart + insulin degludec with or without metformin
Experimental
干预措施: Insulin degludec (Drug)
Faster aspart + insulin degludec with or without metformin
Experimental
干预措施: Metformin (Drug)
NovoRapid/NovoLog + insulin degludec with or without metformin
Active Comparator
干预措施: Insulin aspart (Drug)
NovoRapid/NovoLog + insulin degludec with or without metformin
Active Comparator
干预措施: Insulin degludec (Drug)
NovoRapid/NovoLog + insulin degludec with or without metformin
Active Comparator
干预措施: Metformin (Drug)
结局指标
主要结局
Change in Glycosylated Haemoglobin (HbA1c)
时间窗: Week 0, week 16
Change from baseline (week 0) in glycosylated haemoglobin (HbA1c) was evaluated at week 16. The endpoint was evaluated based on data from the in-trial observation period. In-trial observation period was from date of randomisation and until last trial-related participant-site contact.
次要结局
- Change From Baseline in Mean of the 7-9-7 Point Self-measured Plasma Glucose (SMPG) Profile(Week 0, week 16)
- Change From Baseline of the 7-9-7 Point SMPG Profile: Fluctuation in 7-9-7 Point Profile(Week 0, week 16)
- Total Bolus Insulin Dose: in Units/Day(16 weeks from randomisation)
- Total Bolus Insulin Dose: in Units/kg/Day(16 weeks from randomisation)
- Change From Baseline in 1-hour PPG Increment(Week 0, week 16)
- Participants Who Achieved Overall PPG (1 Hour) <7.8 mmol/L (140 mg/dL) (Yes/No)(16 weeks after randomisation)
- Change From Baseline in 1,5-anhydroglucitol(Week 0, week 16)
- Participants Who Achieved HbA1c <7.0% (53 mmol/L) Without Severe Hypoglycaemia Episodes (Yes/No)(16 weeks after randomisation)
- Change From Baseline of the 7-9-7 Point SMPG Profile: Nocturnal SMPG Measurements(Week 0, week 16)
- Total Basal Insulin Dose: in Units/kg/Day(16 weeks from randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)(Weeks 0-16)
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 2 Hours After Start of the Meal(Weeks 0-16)
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 4 Hours After Start of the Meal(Weeks 0-16)
- Change From Baseline in Fasting Plasma Glucose (FPG)(Week 0, week 16)
- Participants Who Achieved HbA1c <7.0% (53 mmol/L) (Yes/No)(16 weeks after randomisation)
- Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour Postprandial Glucose (PPG [Meal Test])(Week 0, week 16)
- Change From Baseline of the 7-9-7 Point SMPG Profile: PPG (Mean, Breakfast, Lunch and Main Evening Meal)(Week 0, week 16)
- Change From Baseline (Week 0) in 30-minute, 1-hour, 2-hour, 3-hour and 4-hour PPG Increment (Meal Test)(Week 0, week 16)
- Change From Baseline of the 7-9-7 Point SMPG Profile: PPG Increment (Mean, Breakfast, Lunch and Main Evening Meal)(Week 0, week 16)
- Participants Who Achieved Overall PPG <7.8 mmol/L (140 mg/dL) Without Severe Hypoglycaemia Episodes (Yes/No)(16 weeks after randomisation)
- Total Basal Insulin Dose: in Units/Day(16 weeks from randomisation)
- Number of Treatment Emergent Injection Site Reactions(Weeks 0-16)
- Individual Meal Insulin Dose: in Units(16 weeks from randomisation)
- Individual Meal Insulin Dose: in Units/kg(16 weeks from randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes (Hypos) According to the American Diabetes Association (ADA) and Novo Nordisk (NN) Definition: Overall(Weeks 0-16)
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and NN Definition: Hypoglycaemic Episodes Occurring Between 2 to 4 Hours After Start of the Meal(Weeks 0-16)
- Change From Baseline in Lipids-lipoproteins Profile (Total Cholesterol, High Density Lipoproteins, Low Density Lipoproteins) - Ratio to Baseline(Week 0, week 16)
- Number of Treatment Emergent Adverse Events(Weeks 0-16)
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Hypoglycaemic Episodes During First 1 Hour After Start of the Meal(Weeks 0-16)
- Change From Baseline in Vital Signs: Pulse(Week 0, week 16)
- Change From Baseline in Electrocardiogram (ECG)(Week 0, week 16)
- Change From Baseline in Haematology - Thrombocytes(Week 0, week 16)
- Change From Baseline in Biochemistry - Creatinine(Week 0, week 16)
- Number of Treatment Emergent Hypoglycaemic Episodes According to the American Diabetes Association and Novo Nordisk Definition: Daytime Hypoglycaemic Episodes (06:00-00:00 - Inclusive)(Weeks 0-16)
- Change From Baseline in Vital Signs: Systolic and Diastolic Blood Presure(Week 0, week 16)
- Change From Baseline in Biochemistry - Alanine Aminotransferase (ALT)(Week 0, week 16)
- Change From Baseline in Biochemistry - Alkaline Phosphatase(Week 0, week 16)
- Change From Baseline in Biochemistry - Albumin(Week 0, week 16)
- Change From Baseline in Biochemistry - Total Bilirubin(Week 0, week 16)
- Change From Baseline in Physical Examination(Week 0, week 16)
- Change From Baseline in Fundoscopy/Fundus Photography(Week 0, week 16)
- Change From Baseline in Haematology - Haematocrit(Week 0, week 16)
- Change From Baseline in Haematology - Haemoglobin(Week 0, week 16)
- Change From Baseline in Haematology - Leukocytes(Week 0, week 16)
- Change From Baseline in Haematology - Erythrocytes(Week 0, week 16)
- Change From Baseline in Biochemistry - Aspartate Aminotransferase (AST)(Week 0, week 16)
- Change From Baseline in Biochemistry - Sodium(Week 0, week 16)
- Change From Baseline in Biochemistry - Potassium(Week 0, week 16)
- Change From Baseline in Body Mass Index (BMI)(Week 0, week 16)
- Change From Baseline in Biochemistry - Total Protein(Week 0, week 16)
- Change From Baseline in Body Weight(Week 0, week 16)
研究者
研究点 (1)
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