Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
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.
Interventions
DRUGFaster aspart
Administered s.c. (subcutaneously, under the skin) for 16 weeks
DRUGInsulin aspart
Administered s.c. (subcutaneously, under the skin) for 16 weeks
DRUGInsulin degludec
Administered s.c. (subcutaneously, under the skin) for 16 weeks
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Sponsor staff involved in the clinical trial is masked according to company standard procedures
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) | 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. |
| Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol]) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Fasting Plasma Glucose (FPG) | Baseline (week 0), week 16 | 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. |
| 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 | 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. |
| 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 (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. |
| Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Baseline (week 0), week 16 | 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. |
| 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 | 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. |
| Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) | At week 16 | 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. |
| Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) | At week 16 | 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. |
| 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 | 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. |
| 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 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. |
| Insulin Dose (Units/Day): Total Basal | At week 16 | 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. |
| Insulin Dose (Units/Day): Total Bolus | At week 16 | 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. |
| Insulin Dose (Units/Day): Individual Meal Insulin Dose | At week 16 | 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. |
| 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 (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. |
| Insulin Dose (Units/kg/Day): Total Bolus | At week 16 | 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. |
| Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | At week 16 | 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. |
| Number of Treatment Emergent Adverse Events (TEAEs) | From baseline (week 0) to 16 weeks after randomisation | 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. |
| Number of Treatment Emergent Injection Site Reactions | From baseline (week 0) to 16 weeks after randomisation | 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. |
| 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 | 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. |
| 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 | 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 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. |
| 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 | 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. |
| Insulin Dose (Units/kg/Day): Total Basal | At week 16 | 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 |
| 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 (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. |
Countries
China, Hong Kong
Participant flow
Recruitment details
The trial was conducted at 31 sites in China.
Pre-assignment details
The trial included an 8-week run-in period and a 16-week treatment period. During the run-in period, participants received NovoRapid both in combination with insulin degludec with or without metformin primarily for optimisation of the basal insulin treatment. Participants were then randomised 1:1 to receive either 'Faster aspart + insulin degludec with or without metformin' or 'NovoRapid + insulin degludec with or without metformin' during the treatment period.
Participants by arm
| Arm | Count |
|---|---|
| Faster Aspart Participants received subcutaneous injections of NovoRapid + insulin degludec with or without metformin for 8 weeks in the run-in period, followed by Faster aspart + insulin degludec with or without metformin subcutaneously for 16 weeks in the treatment period. During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 millimole per litre (mmol/L) or 71 milligrams per decilitre (mg/dL)) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. Faster aspart was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime plasma glucose (PG) between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. | 150 |
| NovoRapid Participants received subcutaneous injections of NovoRapid thrice daily + insulin degludec once daily with or without metformin for 24 weeks (8 weeks run-in period + 16 weeks treatment period). During the run-in period, insulin degludec dose was adjusted weekly by the investigator based on the mean of three pre-breakfast SMPG values measured on the last two days prior to and on the day of contact. If one of the SMPG values were below target (less than 4.0 mmol/L or 71 mg/dL) then the insulin degludec dose was adjusted according to the titration guideline specified in the protocol. NovoRapid was titrated from randomisation (week 0) and onwards, twice weekly to reach the glycaemic target of pre-prandial and bedtime PG between 4.0-6.0 mmol/L (71 - 108 mg/dL) in a treat-to-target fashion. | 150 |
| Total | 300 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Run-in period | Run-in failure | 0 | 23 |
| Run-in period | Withdrawn before randomisation | 0 | 8 |
| Treatment period | Withdrawal by Subject | 6 | 6 |
Baseline characteristics
| Characteristic | NovoRapid | Total | Faster Aspart |
|---|---|---|---|
| Age, Continuous | 55.24 Years STANDARD_DEVIATION 12.02 | 56.02 Years STANDARD_DEVIATION 11.36 | 56.79 Years STANDARD_DEVIATION 10.65 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 150 Participants | 299 Participants | 149 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 150 Participants | 300 Participants | 150 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Female | 68 Participants | 136 Participants | 68 Participants |
| Sex: Female, Male Male | 82 Participants | 164 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 331 | 0 / 150 | 0 / 150 |
| other Total, other adverse events | 32 / 331 | 55 / 150 | 40 / 150 |
| serious Total, serious adverse events | 9 / 331 | 10 / 150 | 7 / 150 |
Outcome results
Primary
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.
Time frame: Baseline (week 0), week 16
Population: Full analysis set (FAS) which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) | -0.57 Percentage of HbA1c | Standard Deviation 0.63 |
| NovoRapid | Change From Baseline in Glycosylated Haemoglobin (HbA1c) (Percentage [%]) | -0.54 Percentage of HbA1c | Standard Deviation 0.73 |
Comparison: The outcome measure was analysed using mixed-effect model for repeated measurement (MMRM) where all calculated changes in HbA1c from baseline at visits were included in analysis. Model included treatment and stratification of type 1 diabetes mellitus/ type 2 diabetes mellitus (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix described the variability for the repeated measurements for a participant.p-value: 0.510295% CI: [-0.19, 0.09]Mixed Models Analysis
Primary
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.
Time frame: Baseline (week 0), week 16
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol]) | -6.18 mmol/mol | Standard Deviation 6.84 |
| NovoRapid | Change From Baseline in HbA1c (Millimoles Per Mole [mmol/Mol]) | -5.89 mmol/mol | Standard Deviation 7.94 |
Comparison: The outcome measure was analysed using a mixed-effect model for repeated measurements (MMRM) where all calculated changes in HbA1c from baseline at visits are included in the analysis. The model includes treatment and stratification (T1DM/T2DM) as fixed factors, HbA1c at baseline as covariate and interactions between all fixed factors and visit. An unstructured covariance matrix is used to describe the variability for the repeated measurements for a participant.p-value: 0.510295% CI: [-2.08, 1.03]Mixed Models Analysis
Secondary
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.
Time frame: Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 30-min | -1.01 Millimoles per litre (mmol/L) | Standard Deviation 2.31 |
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 1-hour | -0.94 Millimoles per litre (mmol/L) | Standard Deviation 3.08 |
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 2-hour | 0.21 Millimoles per litre (mmol/L) | Standard Deviation 4.16 |
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 3-hour | 0.77 Millimoles per litre (mmol/L) | Standard Deviation 4.01 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 3-hour | 0.65 Millimoles per litre (mmol/L) | Standard Deviation 4.55 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 30-min | 0.18 Millimoles per litre (mmol/L) | Standard Deviation 2.15 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 2-hour | 0.64 Millimoles per litre (mmol/L) | Standard Deviation 4.05 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour Post Prandial Glucose (PPG) Increment (Meal Test) | 1-hour | 0.46 Millimoles per litre (mmol/L) | Standard Deviation 3 |
Secondary
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.
Time frame: Baseline (week 0), week 16 (30 minutes, 1 hour, 2 hour and 3 hour)
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 30-min | -0.64 mmol/L | Standard Deviation 3.06 |
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 1-hour | -0.55 mmol/L | Standard Deviation 3.53 |
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 2-hour | 0.60 mmol/L | Standard Deviation 4.53 |
| Faster aspart | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 3-hour | 1.16 mmol/L | Standard Deviation 4.41 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 3-hour | 0.87 mmol/L | Standard Deviation 4.55 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 30-min | 0.37 mmol/L | Standard Deviation 2.67 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 2-hour | 0.81 mmol/L | Standard Deviation 4.16 |
| NovoRapid | Change From Baseline in 30-minutes, 1-hour, 2-hour and 3-hour PPG (Meal Test) | 1-hour | 0.64 mmol/L | Standard Deviation 3.1 |
Secondary
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.
Time frame: Baseline (week 0), week 16
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile | -0.73 mmol/L | Standard Deviation 1.55 |
| NovoRapid | Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) for Mean of the 7-9-7-point Profile | -0.76 mmol/L | Standard Deviation 1.78 |
Secondary
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.
Time frame: Baseline (week 0), week 16
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after breakfast | -1.01 mmol/L | Standard Deviation 2.38 |
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after lunch | -1.16 mmol/L | Standard Deviation 2.62 |
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after main evening meal | -1.34 mmol/L | Standard Deviation 3.1 |
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after all meals | -1.17 mmol/L | Standard Deviation 1.92 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after all meals | -0.70 mmol/L | Standard Deviation 2.11 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after breakfast | -0.37 mmol/L | Standard Deviation 2.85 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after main evening meal | -0.68 mmol/L | Standard Deviation 2.68 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for 1-hour PPG (Mean, Breakfast, Lunch, Main Evening Meal) | 1 hour after lunch | -1.07 mmol/L | Standard Deviation 2.65 |
Secondary
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.
Time frame: Baseline (week 0), week 16
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline | 0.77 Ratio of 7-9-7-point SMPG | Geometric Coefficient of Variation 55.19 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for Fluctuation in 7-9-7-point Profile: Ratio to Baseline | 0.73 Ratio of 7-9-7-point SMPG | Geometric Coefficient of Variation 47.37 |
Secondary
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.
Time frame: Baseline (week 0), week 16
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis and Number analysed = Number of participants evaluable for each timepoint.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Breakfast | -1.37 mmol/L | Standard Deviation 2.37 |
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Lunch | -1.09 mmol/L | Standard Deviation 2.89 |
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Main evening meal | -0.34 mmol/L | Standard Deviation 2.69 |
| Faster aspart | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | All meals | -0.95 mmol/L | Standard Deviation 1.6 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | All meals | -0.22 mmol/L | Standard Deviation 1.58 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Breakfast | -0.49 mmol/L | Standard Deviation 2.5 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Main evening meal | 0.15 mmol/L | Standard Deviation 2.69 |
| NovoRapid | Change From Baseline in 7-9-7-point SMPG for PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Lunch | -0.19 mmol/L | Standard Deviation 2.6 |
Secondary
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.
Time frame: Baseline (week 0), week 16
Population: FAS which included all randomised participants. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Change From Baseline in Fasting Plasma Glucose (FPG) | 0.39 mmol/L | Standard Deviation 2.5 |
| NovoRapid | Change From Baseline in Fasting Plasma Glucose (FPG) | 0.20 mmol/L | Standard Deviation 2.11 |
Secondary
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.
Time frame: At week 16
Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster aspart | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Breakfast | 12.00 Units/day | Standard Deviation 5.9 |
| Faster aspart | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Lunch | 13.67 Units/day | Standard Deviation 6.02 |
| Faster aspart | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Main evening meal | 13.82 Units/day | Standard Deviation 6.38 |
| NovoRapid | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Breakfast | 11.54 Units/day | Standard Deviation 6.12 |
| NovoRapid | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Lunch | 13.84 Units/day | Standard Deviation 6.11 |
| NovoRapid | Insulin Dose (Units/Day): Individual Meal Insulin Dose | Main evening meal | 13.78 Units/day | Standard Deviation 5.89 |
Secondary
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.
Time frame: At week 16
Population: Safety analysis set (SAS) which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Insulin Dose (Units/Day): Total Basal | 27.01 Units/day | Standard Deviation 14.37 |
| NovoRapid | Insulin Dose (Units/Day): Total Basal | 27.21 Units/day | Standard Deviation 13.3 |
Secondary
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.
Time frame: At week 16
Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Insulin Dose (Units/Day): Total Bolus | 39.49 Units/day | Standard Deviation 17.08 |
| NovoRapid | Insulin Dose (Units/Day): Total Bolus | 39.16 Units/day | Standard Deviation 16.9 |
Secondary
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.
Time frame: At week 16
Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster aspart | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Breakfast | 0.17 Units/kg/day | Standard Deviation 0.08 |
| Faster aspart | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Lunch | 0.19 Units/kg/day | Standard Deviation 0.08 |
| Faster aspart | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Main evening meal | 0.20 Units/kg/day | Standard Deviation 0.09 |
| NovoRapid | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Breakfast | 0.17 Units/kg/day | Standard Deviation 0.09 |
| NovoRapid | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Lunch | 0.20 Units/kg/day | Standard Deviation 0.09 |
| NovoRapid | Insulin Dose (Units/kg/Day): Individual Meal Insulin Dose | Main evening meal | 0.20 Units/kg/day | Standard Deviation 0.09 |
Secondary
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
Time frame: At week 16
Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Insulin Dose (Units/kg/Day): Total Basal | 0.37 Units/(kilogram) kg/day | Standard Deviation 0.19 |
| NovoRapid | Insulin Dose (Units/kg/Day): Total Basal | 0.39 Units/(kilogram) kg/day | Standard Deviation 0.17 |
Secondary
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.
Time frame: At week 16
Population: SAS which included all participants receiving at least one dose of randomised treatment. Number of participants analysed = Number of participants contributed to the analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster aspart | Insulin Dose (Units/kg/Day): Total Bolus | 0.56 Units/kg/day | Standard Deviation 0.23 |
| NovoRapid | Insulin Dose (Units/kg/Day): Total Bolus | 0.57 Units/kg/day | Standard Deviation 0.25 |
Secondary
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.
Time frame: At week 16
Population: FAS which included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster aspart | Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) | Yes | 59 Participants |
| Faster aspart | Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) | No | 91 Participants |
| NovoRapid | Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) | Yes | 55 Participants |
| NovoRapid | Number of Participants Who Achieved HbA1c <7.0% Without Severe Hypoglycaemia Episodes (Yes/No) | No | 95 Participants |
Secondary
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.
Time frame: At week 16
Population: FAS which included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster aspart | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) | Yes | 59 Participants |
| Faster aspart | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) | No | 91 Participants |
| NovoRapid | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) | Yes | 55 Participants |
| NovoRapid | Number of Participants Who Achieved HbA1c Less Than (<) 7.0 (Percent [%]) (Yes/No) | No | 95 Participants |
Secondary
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.
Time frame: At week 16
Population: FAS which included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster aspart | 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) | Yes | 61 Participants |
| Faster aspart | 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) | No | 89 Participants |
| NovoRapid | 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) | Yes | 51 Participants |
| NovoRapid | 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) | No | 99 Participants |
Secondary
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.
Time frame: At week 16
Population: FAS which included all randomised participants.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Faster aspart | 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) | Yes | 61 Participants |
| Faster aspart | 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) | No | 89 Participants |
| NovoRapid | 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) | Yes | 51 Participants |
| NovoRapid | 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) | No | 99 Participants |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster aspart | Number of Treatment Emergent Adverse Events (TEAEs) | 285 Events |
| NovoRapid | Number of Treatment Emergent Adverse Events (TEAEs) | 263 Events |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | 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) | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | 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) | ADA: Severe | 0 Episodes |
| Faster aspart | 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) | NN: BG confirmed | 375 Episodes |
| Faster aspart | 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) | ADA: Probable symptomatic | 0 Episodes |
| Faster aspart | 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) | NN: Severe or BG confirmed symptomatic | 292 Episodes |
| Faster aspart | 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) | ADA: Documented symptomatic | 863 Episodes |
| Faster aspart | 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) | NN: Severe or BG confirmed | 375 Episodes |
| Faster aspart | 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) | ADA: Pseudo-hypoglycaemia | 11 Episodes |
| Faster aspart | 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) | NN: Unclassifiable | 0 Episodes |
| Faster aspart | 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) | ADA: Asymptomatic | 440 Episodes |
| NovoRapid | 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) | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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) | ADA: Severe | 0 Episodes |
| NovoRapid | 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) | ADA: Asymptomatic | 390 Episodes |
| NovoRapid | 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) | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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) | ADA: Pseudo-hypoglycaemia | 27 Episodes |
| NovoRapid | 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) | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | 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) | NN: BG confirmed | 417 Episodes |
| NovoRapid | 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) | NN: Severe or BG confirmed symptomatic | 327 Episodes |
| NovoRapid | 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) | NN: Severe or BG confirmed | 417 Episodes |
| NovoRapid | 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) | ADA: Documented symptomatic | 927 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | 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 | ADA: Severe | 0 Episodes |
| Faster aspart | 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 | ADA: Documented symptomatic | 265 Episodes |
| Faster aspart | 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 | ADA: Asymptomatic | 109 Episodes |
| Faster aspart | 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 | ADA: Probable symptomatic | 0 Episodes |
| Faster aspart | 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 | ADA: Pseudo-hypoglycaemia | 3 Episodes |
| Faster aspart | 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 | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | 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 | NN: BG confirmed | 147 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed symptomatic | 118 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed | 147 Episodes |
| Faster aspart | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 112 Episodes |
| NovoRapid | 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 | ADA: Severe | 0 Episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 286 Episodes |
| NovoRapid | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 94 Episodes |
| NovoRapid | 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 | NN: BG confirmed | 136 Episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 136 Episodes |
| NovoRapid | 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 | ADA: Pseudo-hypoglycaemia | 7 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | 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 | ADA: Severe | 0 Episodes |
| Faster aspart | 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 | ADA: Documented symptomatic | 43 Episodes |
| Faster aspart | 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 | ADA: Asymptomatic | 17 Episodes |
| Faster aspart | 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 | ADA: Probable symptomatic | 0 Episodes |
| Faster aspart | 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 | ADA: Pseudo-hypoglycaemia | 1 Episodes |
| Faster aspart | 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 | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | 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 | NN: BG confirmed | 24 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed symptomatic | 20 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed | 24 Episodes |
| Faster aspart | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 20 Episodes |
| NovoRapid | 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 | ADA: Severe | 0 Episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 41 Episodes |
| NovoRapid | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 17 Episodes |
| NovoRapid | 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 | NN: BG confirmed | 24 Episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 24 Episodes |
| NovoRapid | 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 | ADA: Pseudo-hypoglycaemia | 0 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | 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 | ADA: Severe | 0 Episodes |
| Faster aspart | 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 | ADA: Documented symptomatic | 126 Episodes |
| Faster aspart | 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 | ADA: Asymptomatic | 33 Episodes |
| Faster aspart | 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 | ADA: Probable symptomatic | 0 Episodes |
| Faster aspart | 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 | ADA: Pseudo-hypoglycaemia | 3 Episodes |
| Faster aspart | 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 | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | 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 | NN: BG confirmed | 66 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed symptomatic | 58 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed | 66 Episodes |
| Faster aspart | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 69 Episodes |
| NovoRapid | 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 | ADA: Severe | 0 Episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 147 Episodes |
| NovoRapid | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 39 Episodes |
| NovoRapid | 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 | NN: BG confirmed | 81 Episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 81 Episodes |
| NovoRapid | 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 | ADA: Pseudo-hypoglycaemia | 4 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | 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 | ADA: Severe | 0 Episodes |
| Faster aspart | 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 | ADA: Documented symptomatic | 6 Episodes |
| Faster aspart | 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 | ADA: Asymptomatic | 1 Episodes |
| Faster aspart | 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 | ADA: Probable symptomatic | 0 Episodes |
| Faster aspart | 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 | ADA: Pseudo-hypoglycaemia | 0 Episodes |
| Faster aspart | 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 | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | 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 | NN: BG confirmed | 2 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed symptomatic | 2 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed | 2 Episodes |
| Faster aspart | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 3 Episodes |
| NovoRapid | 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 | ADA: Severe | 0 Episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 8 Episodes |
| NovoRapid | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 1 Episodes |
| NovoRapid | 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 | NN: BG confirmed | 3 Episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 3 Episodes |
| NovoRapid | 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 | ADA: Pseudo-hypoglycaemia | 0 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | 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 | ADA: Severe | 0 Episodes |
| Faster aspart | 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 | ADA: Documented symptomatic | 391 Episodes |
| Faster aspart | 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 | ADA: Asymptomatic | 142 Episodes |
| Faster aspart | 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 | ADA: Probable symptomatic | 0 Episodes |
| Faster aspart | 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 | ADA: Pseudo-hypoglycaemia | 6 Episodes |
| Faster aspart | 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 | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | 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 | NN: BG confirmed | 213 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed symptomatic | 176 Episodes |
| Faster aspart | 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 | NN: Severe or BG confirmed | 213 Episodes |
| Faster aspart | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed symptomatic | 181 Episodes |
| NovoRapid | 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 | ADA: Severe | 0 Episodes |
| NovoRapid | 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 | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Documented symptomatic | 433 Episodes |
| NovoRapid | 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 | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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 | ADA: Asymptomatic | 133 Episodes |
| NovoRapid | 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 | NN: BG confirmed | 217 Episodes |
| NovoRapid | 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 | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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 | NN: Severe or BG confirmed | 217 Episodes |
| NovoRapid | 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 | ADA: Pseudo-hypoglycaemia | 11 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | 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) | NN: BG confirmed | 28 Episodes |
| Faster aspart | 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) | NN: Unclassifiable | 0 Episodes |
| Faster aspart | 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) | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | 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) | ADA: Severe | 0 Episodes |
| Faster aspart | 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) | NN: Severe or BG confirmed symptomatic | 24 Episodes |
| Faster aspart | 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) | ADA: Documented symptomatic | 49 Episodes |
| Faster aspart | 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) | ADA: Pseudo-hypoglycaemia | 1 Episodes |
| Faster aspart | 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) | ADA: Asymptomatic | 10 Episodes |
| Faster aspart | 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) | NN: Severe or BG confirmed | 28 Episodes |
| Faster aspart | 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) | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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) | NN: Severe or BG confirmed | 19 Episodes |
| NovoRapid | 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) | ADA: Pseudo-hypoglycaemia | 3 Episodes |
| NovoRapid | 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) | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | 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) | NN: BG confirmed | 19 Episodes |
| NovoRapid | 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) | NN: Severe or BG confirmed symptomatic | 19 Episodes |
| NovoRapid | 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) | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | 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) | NN: Unclassifiable | 0 Episodes |
| NovoRapid | 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) | ADA: Severe | 0 Episodes |
| NovoRapid | 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) | ADA: Documented symptomatic | 43 Episodes |
| NovoRapid | 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) | ADA: Asymptomatic | 10 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Severe | 1 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Documented symptomatic | 915 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Asymptomatic | 453 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Probable symptomatic | 0 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Pseudo-hypoglycaemia | 12 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Unclassifiable | 0 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: BG confirmed | 404 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed symptomatic | 316 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed | 404 Episodes |
| Faster aspart | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: Unclassifiable | 1 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed symptomatic | 347 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Severe | 0 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Unclassifiable | 0 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Documented symptomatic | 971 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: Unclassifiable | 0 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Asymptomatic | 402 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: BG confirmed | 438 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Probable symptomatic | 0 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | NN: Severe or BG confirmed | 438 Episodes |
| NovoRapid | Number of Treatment Emergent Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition: Overall | ADA: Pseudo-hypoglycaemia | 30 Episodes |
Secondary
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.
Time frame: From baseline (week 0) to 16 weeks after randomisation
Population: SAS which included all participants receiving at least one dose of randomised treatment.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster aspart | Number of Treatment Emergent Injection Site Reactions | 0 Events |
| NovoRapid | Number of Treatment Emergent Injection Site Reactions | 0 Events |