Efficacy and Safety of Fast-acting Insulin Aspart Compared to NovoRapid® Both in Combination With Insulin Degludec With or Without Metformin in Adults With Diabetes
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 331
- 试验地点
- 40
- 主要终点
- Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])
研究概览
简要总结
Fast-acting insulin aspart (faster aspart) will be tested to see how well it works and if it is safe. The study compares 2 medicines for type 1 and type 2 diabetes - faster aspart (a new medicine) and insulin aspart (a medicine doctors can already prescribe). Participants will either get faster aspart or insulin aspart (NovoRapid®) - which treatment is decided by chance. Both medicines will be taken together with insulin degludec. Participants will need to take 1 injection 4 times every day: 3 injections 0-2 minutes before breakfast, lunch and dinner and 1 injection at the same time every day. All study medicines are provided in pens. A pen is a tool to inject insulin under the skin.The study will last for about 7 months (30 weeks). Participants will have 11 clinic visits and 17 phone contacts with the study doctor. At 8 clinic visits participants will have blood samples taken. At 3 clinic visits participants cannot eat or drink (water is allowed) 8 hours before the visits - at 2 of these visits participants will be asked to drink a liquid meal and to stay at the clinic for about 5 hours. Participants will fill in a diary the last 3 days before the visits/phone contacts. Women cannot take part if pregnant, breast-feeding or planning to become pregnant during the study period.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, age above or equal to 18 years at the time of signing informed consent
- •Diagnosed with Diabetes Mellitus, Type 1 (T1DM) at least or equal to 1 year prior to screening or diagnosed with Diabetes Mellitus, Type 2 (T2DM) at least or equal to 5 years prior to screening
- •Treated with a basal-bolus insulin regimen or a premix insulin regimen at least or equal to 1 year prior to screening. Insulin regimen must be unchanged within 60 days prior to screening. A basal-bolus insulin regimen is defined as basal insulin once or twice daily and bolus insulin taken with meals at least thrice daily. A premix insulin regimen is defined as premix insulin twice or thrice daily
- •For subjects with T1DM: not treated with any oral anti-diabetes drugs (OADs) for at least 90 days prior to screening. For subjects with T2DM: not treated with any OADs or treated with 1-2 OADs within 90 days prior to screening. Allowed OADs are metformin, alpha-glucosidase inhibitor, sodium-glucose co-transporter-2 inhibitors (SGLT2i) and dipeptidyl peptidase-4 inhibitors (DPP4i). Change in OAD and dose prior to screening is allowed.
- •HbA1c 7.5-9.5% (both inclusive) as assessed by central laboratory at screening
排除标准
- •Any of the following: myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within the past 180 days prior to the day of screening
- •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
- •Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening
- •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
4 daily injections of faster aspart given with insulin degludec and with or without metformin
干预措施: Faster aspart (Drug)
Faster aspart
4 daily injections of faster aspart given with insulin degludec and with or without metformin
干预措施: Insulin degludec (Drug)
Insulin aspart
4 daily injections of insulin aspart given with insulin degludec and with or without metformin
干预措施: Insulin aspart (Drug)
Insulin aspart
4 daily injections of insulin aspart given with insulin degludec and with or without metformin
干预措施: Insulin degludec (Drug)
结局指标
主要结局
Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])
时间窗: Baseline (week 0), week 16
Change from baseline (week 0) in HbA1c (mmol/mol) was evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])
时间窗: Baseline (week 0), week 16
Change from baseline (week 0) in HbA1c (%) as evaluated after 16 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
次要结局
- Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile(Baseline (week 0), week 16)
- Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No)(At week 16)
- Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L Without Severe Hypoglycaemia (Yes/No)(At week 16)
- Number of Treatment Emergent Adverse Events (TEAEs)(From baseline (week 0) to 16 weeks after randomisation)
- Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test)(Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour))
- Change From Baseline in Fasting Plasma Glucose (FPG)(Baseline (week 0), week 16)
- Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No)(At week 16)
- Insulin Dose (Units/Day): Individual Meal Insulin Dose(At week 16)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall(From baseline (week 0) to 16 weeks after randomisation)
- Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test)(Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour))
- Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal)(Baseline (week 0), week 16)
- Change From Baseline in 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline(Baseline (week 0), week 16)
- Insulin Dose (Units/Day): Total Basal(At week 16)
- Insulin Dose (Units/Day): Total Bolus(At week 16)
- Insulin Dose (Units/kg/Day): Total Bolus(At week 16)
- Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose(At week 16)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Day Time Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)(From baseline (week 0) to 16 weeks after randomisation)
- Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)(Baseline (week 0), week 16)
- Number of Participants Who Achieved PPG Target (Overall Mean of Daily PPG Measurements in SMPG) for Overall PPG (1-hour) Less Than or Equal (≤) to 7.8 mmol/L (Yes/No)(At week 16)
- Insulin Dose (Units/kg/Day): Total Basal(At week 16)
- Number of Treatment Emergent Injection Site Reactions(From baseline (week 0) to 16 weeks after randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)(From baseline (week 0) to 16 weeks after randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 30 Minutes(From baseline (week 0) to 16 weeks after randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 1 Hour(From baseline (week 0) to 16 weeks after randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 2 Hours(From baseline (week 0) to 16 weeks after randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From Start of Meal Until 4 Hours(From baseline (week 0) to 16 weeks after randomisation)
- Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the ADA Definition and NN Definition: Hypoglycaemic Episodes From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal(From baseline (week 0) to 16 weeks after randomisation)