NCT02500706已完成3 期
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Adults With Type 1 Diabetes
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
- 1,108
- 试验地点
- 1
- 主要终点
- Change From Baseline in HbA1c 26 Weeks After Randomisation
研究概览
简要总结
This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 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
- Double (Participant, Investigator)
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 greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m^2
排除标准
- •Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)
研究组 & 干预措施
Mealtime faster-acting insulin aspart and insulin degludec
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Mealtime faster-acting insulin aspart and insulin degludec
Experimental
干预措施: insulin degludec (Drug)
Mealtime NovoRapid® and insulin degludec
Active Comparator
干预措施: insulin aspart (Drug)
Mealtime NovoRapid® and insulin degludec
Active Comparator
干预措施: insulin degludec (Drug)
Postmeal faster-acting insulin aspart and insulin degludec
Experimental
干预措施: Faster-acting insulin aspart (Drug)
Postmeal faster-acting insulin aspart and insulin degludec
Experimental
干预措施: insulin degludec (Drug)
结局指标
主要结局
Change From Baseline in HbA1c 26 Weeks After Randomisation
时间窗: Week 0, week 26
Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
次要结局
- Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation(26 weeks after randomisation)
- Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)(Week 0, week 26)
- Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation(Week 0, week 26)
- Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation(26 weeks after randomisation)
- Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation(26 weeks after randomisation)
- Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile(Week 0, week 26)
- Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)(Week 0, week 26)
- Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)(Week 0, week 26)
- Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile(Week 0, week 26)
- Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements(Week 0, week 26)
- Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L(26 weeks after randomisation)
- Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia(26 weeks after randomisation)
- Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia(26 weeks after randomisation)
- Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)(Week 0, week 26)
- Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)(Week 0, week 26)
- Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation(Week 0 to week 26 (+7 days))
- Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation(Week 0 to week 26 (+7 days))
- Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall(Week 0 to week 26 (+1 day))
- Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)(Week 0 to week 26 (+1 day))
- Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal(Week 0 to week 26 (+1 day))
- Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)(Week 0, week 26)
- Change From Baseline in Blood Pressure 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Pulse 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Erythrocytes 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Haematocrit 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Haemoglobin 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Leukocytes 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Thrombocytes 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Albumin 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Total Bilirubin 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Potassium 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Creatinine 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Total Protein 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Body Weight 26 Weeks After Randomisation(Week 0, week 26)
- Change From Baseline in Body Mass Index 26 Weeks After Randomisation(Week 0, week 26)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
Efficacy and Safety of Faster-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec in Children and Adolescents With Type 1 DiabetesDiabetes Mellitus, Type 1DiabetesNCT02670915Novo Nordisk A/S834
已完成
3 期
Efficacy and Safety of FIAsp Compared to Insulin Aspart in Combination With Insulin Glargine and Metformin in Adults With Type 2 DiabetesDiabetesDiabetes Mellitus, Type 2NCT01819129Novo Nordisk A/S881
已完成
1 期
A Trial Investigating the Pharmacokinetic and Pharmacodynamic Properties of Faster-acting Insulin Aspart in Subjects With Type 2 Diabetes MellitusDiabetesDiabetes Mellitus, Type 2NCT02933853Novo Nordisk A/S61
已完成
3 期
Comparison of Insulin Detemir With NPH Insulin in Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT00184665Novo Nordisk A/S501
已完成
3 期
Efficacy and Safety of FIAsp Compared to Insulin Aspart Both in Combination With Insulin Detemir in Adults With Type 1 DiabetesDiabetesDiabetes Mellitus, Type 1NCT01831765Novo Nordisk A/S1,290