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

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Drug: Faster aspart; Drug: Insulin degludec; Drug: Insulin aspart

• Study Type: Interventional
• Enrollment (Actual): 331
• Phase: Phase 3

Contacts and Locations

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China, 230001
      • Anhui Provincial Hospital
    • Hefei, Anhui, China, 230061
      • The First Affiliated Hospital of Anhui Medical University
  • Beijing
    • Beijing, Beijing, China, 100020
      • Beijing Chao-Yang Hospital, Capital Medical University
    • Beijing, Beijing, China, 100853
      • Chinese People's Liberation Army General Hospital
    • Beijing, Beijing, China, 101200
      • Beijing Pinggu Hospital
  • Chongqing
    • ChongQing, Chongqing, China, 404000
      • Chongqing University Three Gorges Hospital
  • Guangdong
    • Guangzhou, Guangdong, China, 510120
      • Sun Yat-sen Memorial Hospital, Sun Yat-sen Universtiy
    • Shantou, Guangdong, China, 515065
      • The 2nd Affiliated Hospital of Shantou Uni Medical College
  • Guangxi
    • Nanning, Guangxi, China, 53007
      • The Second Affiliated Hospital of Guangxi Medical University
  • Hebei
    • Cangzhou, Hebei, China, 061000
      • Cangzhou People's Hospital
    • Hengshui, Hebei, China, 053000
      • Harrison International Peace Hospital
    • Shijiazhuang, Hebei, China, 050000
      • The Second Hospital of Hebei Medical University
    • Tangshan, Hebei, China, 063000
      • Tangshan Gongren Hospital
  • Hunan
    • Yueyang, Hunan, China, 414000
      • Yueyang Central Hospital
  • Inner Mongolia
    • Huhehaote, Inner Mongolia, China, 010020
      • Inner Mongolia People's Hospital
    • Huhhot, Inner Mongolia, China, 010050
      • The Affiliated Hospital of Inner Mongolia Medical University
  • Jiangsu
    • Changzhou, Jiangsu, China, 213003
      • Changzhou No.2 People's Hospital, Yanghu Branch
    • Nanjing, Jiangsu, China, 210029
      • Jiangsu Province Hospital
    • Nanjing, Jiangsu, China, 211199
      • Nanjing Jiangning Hospital
    • Nanjing, Jiangsu, China, 210011
      • The Second Affiliated Hospital of Nanjing Medical University_Nanjing
    • Suzhou, Jiangsu, China, 215006
      • The First Affiliated Hospital of Soochow University
    • Suzhou, Jiangsu, China, 215002
      • Suzhou Municipal Hospital
    • Zhenjiang, Jiangsu, China, 212001
      • The Affiliated Hospital of Jiangsu University_Zhenjiang
  • Jiangxi
    • Nanchang, Jiangxi, China, 330006
      • Jiangxi Provincial People's Hospital
  • Jilin
    • Changchun, Jilin, China, 130021
      • The First Hospital of Jilin University
    • Changchun, Jilin, China, 130041
      • The Second Hospital of Jilin University
    • Changchun, Jilin, China, 130033
      • China-Japan Union Hospital of Jilin University_Changchun
  • Qinghai
    • Xining, Qinghai, China, 810007
      • Qinghai Provincial People's Hospital
  • Shandong
    • Ji'nan, Shandong, China, 250013
      • Jinan Central Hospital
  • Shanghai
    • Shanghai, Shanghai, China, 200240
      • Shanghai Fifth People's Hospital
    • Shanghai, Shanghai, China, 200072
      • Shanghai Tenth People's Hsopital, Tongji University
    • Shanghai, Shanghai, China, 201199
      • Central Hospital of Minhang District
  • Tianjin
    • Tianjin, Tianjin, China, 300052
      • General Hospital of Tianjin Medical University
  • Yunnan
    • Kunming, Yunnan, China, 650101
      • The Second Affiliated hospital of Kunming Medical University
    • Kunming, Yunnan, China, 650032
      • The First People's Hospital of Yunnan Province
    • Kunming, Yunnan, China, 650032
      • First Affiated Hospital of Kunming Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%])	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.	Baseline (week 0), week 16
Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol])	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.	Baseline (week 0), week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test)	Change from baseline (week 0) in 30-minute, 1-hour, 2-hour and 3-hour PPG increment (meal test) was evaluated at 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The participants were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The participants were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2 and 3 hours from the start of the meal. PPG incremental value for each time point was derived as PPG value at that time point minus the preprandial glucose value.	Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test)	Change from baseline (week 0) in 30-minute, 1-hour, 2-hour and 3-hour PPG (meal test) was evaluated at 16 weeks. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. Meal test: The participants were given a carbohydrate-rich standardised liquid meal immediately after bolus (faster aspart or NovoRapid) infusion in the morning of the meal test. The participants were to consume the meal as quickly as possible (within 12 minutes) and blood samples were drawn after 30 minutes, 1, 2 and 3 hours from the start of the meal.	Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline (week 0) in fasting plasma glucose (FPG) 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.	Baseline (week 0), week 16
Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile	Change from baseline (week 0) in mean of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The mean of the 7-9-7-point profile was defined as the area under the curve profile divided by the measurement time, and was calculated using the linear trapezoidal technique. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	Baseline (week 0), week 16
Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal)	Change from baseline (week 0) in 1-hour PPG (breakfast, lunch, main evening meal and mean over all meals) of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. Results were derived from the three profiles: post-breakfast, post-lunch, post-main evening meal. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	Baseline (week 0), week 16
Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)	Change from baseline (week 0) in PPG increment of the 7-9-7 point SMPG profile was evaluated after 16 weeks of randomisation. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. PPG increment for each meal was derived from the 7-point and 9-point profile as the difference between PPG values and the PG value before the meal in each separate profile. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	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	Fluctuation in SMPG profile was the average absolute difference from the mean of the SMPG profile. Change from baseline is represented as ratio to baseline value. 7-9-7 SMPG point profile was performed on the 3 consecutive days just before selected visit. 7-point profile (day 3 and day 1 before selected visit): before breakfast, 60 minutes after the start of breakfast, before lunch, 60 minutes after the start of lunch, before main evening meal, 60 minutes after the start of main evening meal, and at bedtime. 9-point profile (day 2 before selected visit) included all timepoints of 7-points profile with addition of SMPG measurement at 4 a.m. and before breakfast on the following day. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	Baseline (week 0), week 16
Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No)	Number of participants who achieved HbA1c < 7% measured as 53 mmol/mol at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values < 7% and "No" infers the number of participants who have not achieved HbA1c values < 7%. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	At week 16
Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No)	Number of participants who achieved HbA1c < 7% (measured as 53 mmol/mol) without severe hypoglycaemia episodes at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved HbA1c values < 7% without severe hypoglycaemia episodes and "No" infers the number of participants who have not achieved HbA1c values less than the 7%. without severe hypoglycaemia episodes The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	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 (Yes/No)	Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L measured as 140 milligrams per deciliter (mg/dL) at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	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)	Number of participants who achieved overall PPG (1-hour) ≤ 7.8 mmol/L (measured as 140 mg/dL) without severe hypoglycaemia at week 16 is presented. In the reported data, "Yes" infers the number of participants who have achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia and "No" infers the number of participants who have not achieved overall PPG (1-hour) values ≤ 7.8 mmol/L without severe hypoglycaemia. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.	At week 16
Insulin Dose (Units/Day): Total Basal	Total basal insulin dose was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.	At week 16
Insulin Dose (Units/Day): Total Bolus	Total bolus insulin dose was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.	At week 16
Insulin Dose (Units/Day): Individual Meal Insulin Dose	Individual meal time bolus insulin dose for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.	At week 16
Insulin Dose (Units/kg/Day): Total Basal	Total basal insulin dose was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period	At week 16
Insulin Dose (Units/kg/Day): Total Bolus	Total bolus insulin dose was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.	At week 16
Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose	Individual meal time bolus insulin dose for breakast, lunch and main evening meal was evaluated after 16 weeks of randomisation. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.	At week 16
Number of Treatment Emergent Adverse Events (TEAEs)	Number of treatment emergent adverse events were recorded from week 0 to week 16. An AE was defined as any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. TEAE was defined as an event that had an onset date on or after the first day of exposure to randomised treatment, and no later than seven days after the last day of exposure to randomised treatment.	From baseline (week 0) to 16 weeks after randomisation
Number of Treatment Emergent Injection Site Reactions	Number of treatment emergent injection site reactions were recorded from week 0 to week 16. The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.	From baseline (week 0) to 16 weeks after randomisation
Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall	ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	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: Day Time Hypoglycaemic Episodes (00:01-05:59 - Both Inclusive)	Number of treatment emergent day time hypoglycaemic episodes as per ADA and NN definitions were evaluated. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	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)	Number of treatment emergent nocturnal hypoglycaemic episodes as per ADA and NN definitions were evaluated. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	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	Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 30-mins after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	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	Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 1 hour after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	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	Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 2 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	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	Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated during first 4 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	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	Number of treatment emergent hypoglycaemic episodes as per ADA and NN definitions were evaluated from 2 hours to 4 hours after start of meal. ADA classification of hypoglycaemia as follows: 1) Severe: Requiring assistance to actively administer carbohydrate/glucagon/take other corrective actions. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo-hypoglycaemia: PG >3.9 mmol/L with symptoms. 6) Unclassifiable. NN classification of hypoglycaemia as follows: 1) BG confirmed: PG <3.1 mmol/L with/without symptoms. 2) Severe or BG confirmed symptomatic: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with symptoms. 3) Severe or BG confirmed: Severe as per ADA and BG confirmed by PG <3.1 mmol/L with/without symptoms. 4) Unclassifiable. Not able to self-treat-unclassifiable: Not able to self-treat but not classifiable as severe hypoglycaemia.	From baseline (week 0) to 16 weeks after randomisation

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency (dept. 1452), Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2020
• Primary Completion (Actual): July 5, 2022
• Study Completion (Actual): August 5, 2022

Study Registration Dates

• First Submitted: October 9, 2020
• First Submitted That Met QC Criteria: October 9, 2020
• First Posted (Actual): October 19, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 16, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1; Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
• Other Study ID Numbers: NN1218-4357; U1111-1197-8289 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No