Research Study to Compare a New Medicine Fast-acting Insulin Aspart to Another Medicine Insulin Aspart in Chinese People With Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Faster aspart
* Drug: Insulin aspart
* Drug: Insulin degludec


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Faster aspart<br>4 daily injections of faster aspart given with insulin degludec and with or without metformin | Drug: Faster aspart<br>* Administered s.c. (subcutaneously, under the skin) for 16 weeks<br>Drug: Insulin degludec<br>* Administered s.c. (subcutaneously, under the skin) for 16 weeks<br>|
| Active Comparator: Insulin aspart<br>4 daily injections of insulin aspart given with insulin degludec and with or without metformin | Drug: Insulin aspart<br>* Administered s.c. (subcutaneously, under the skin) for 16 weeks<br>Drug: Insulin degludec<br>* Administered s.c. (subcutaneously, under the skin) for 16 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in glycosylated haemoglobin (HbA1c) | Percentage points | From baseline (week 0) to week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) increment (meal test) | mmol/L | From baseline (week 0) to 16 weeks after randomisation | 
| Change in 30-minutes, 1-hour, 2-hour and 3-hour post prandial glucose (PPG) (meal test) | mmol/L | From baseline (week 0) to 16 weeks after randomisation | 
| Change in fasting plasma glucose (FPG) | mmol/L | From baseline (week 0) to 16 weeks after randomisation | 
| If a subject achieves HbA1c target: HbA1c below 7.0% | Yes/no | At 16 weeks after randomisation | 
| If a subject achieves HbA1c target: HbA1c below 7.0% without severe hypoglycaemia | Yes/no | At 16 weeks after randomisation | 
| Change in 7-9-7-point self-measured plasma glucose (SMPG): Mean of the 7-9-7-point profile | mmol/L | From baseline (week 0) to 16 weeks after randomisation | 
| Change in 7-9-7-point self-measured plasma glucose (SMPG): 1-hour PPG and PPG increment (mean, breakfast, lunch, main evening meal) | mmol/L | From baseline (week 0) to 16 weeks after randomisation | 
| Change in 7-9-7-point self-measured plasma glucose (SMPG): Fluctuation in 7-9-7-point profile | mmol/L | From baseline (week 0) to 16 weeks after randomisation | 
| If a subject achieves PPG target (overall mean of daily PPG measurements in SMPG): Overall PPG (1-hour) equal to or below 7.8 mmol/L | Yes/no | At 16 weeks after randomisation | 
| If a subject achieves PPG target (overall mean of daily PPG measurements in SMPG): Overall PPG (1-hour) equal to or below 7.8 mmol/L without severe hypoglycaemia | Yes/no | At 16 weeks after randomisation | 
| Insulin dose (Units/day and Units/kg/day; total basal, total bolus and individual meal insulin dose) | Units | At 16 weeks after randomisation | 
| Number of treatment emergent adverse events | Count | From week 0 to week 16 | 
| Number of treatment emergent injection site reactions | Count | From week 0 to week 16 | 
| Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Overall | Count | From week 0 to week 16 | 
| Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk definition: Daytime and nocturnal hypoglycaemic episodes (00:01-05:59 - both inclusive) | Count | From week 0 to week 16 | 
| Number of treatment emergent hypoglycaemic episodes classified both according to the American Diabetes Association (ADA) definition and Novo Nordisk (NN) definition | Count. ADA and NN definition of treatment emergent hypoglycaemic episodes: Hypoglycaemic episodes from start of meal until 30 minutes, 1, 2, 4 hours and from 2 hours (exclusive) to 4 hours (inclusive) after start of meal | From week 0 to week 16 |