Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Asia, Europe and North America. The purpose is to confirm efficacy in terms of glycaemic control of treatment with mealtime faster-acting insulin aspart in combination with insulin degludec in adults with Type 1 Diabetes Mellitus.
Interventions
DRUGFaster-acting insulin aspart
Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal. Postmeal dosing is defined as injecting 20 minutes after the start of the meal.
DRUGinsulin aspart
Injected subcutaneously (under the skin) three times daily for 26 weeks. Dose individually adjusted. Mealtime dosing is defined as injecting 0-2 minutes before the meal.
DRUGinsulin degludec
Injected subcutaneously (under the skin) once daily for 26 weeks. Dose individually adjusted
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Male or female, age greater than or equal to 18 years ( for Japan and Taiwan: age greater than or equal to 20 years) at the time of signing informed consent - Type 1 Diabetes Mellitus (based on clinical judgement and/or supported by laboratory analysis as per local guidelines) 12 months or more prior to screening - Currently treated with a basal-bolus insulin regimen for at least 12 months prior to screening (Visit 1) - Currently treated with a basal insulin analogue for at least 4 months prior to screening (Visit 1) - HbA1c 7.0-9.5% (53-80 mmol/mol) (both inclusive) as assessed by central laboratory - Body Mass Index less than or equal to 35.0 kg/m\^2
Exclusion criteria
- Within the past 180 days any of the following: myocardial infarction, stroke or hospitalization for unstable angina and/or transient ischemic attack - Subjects presently classified as being in New York Heart Association (NYHA) Class IV Currently planned coronary, carotid or peripheral artery revascularisation - Diabetic ketoacidosis requiring hospitalisation within the last 180 days prior to screening (Visit 1) - Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of three months before screening (Visit 1)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in HbA1c 26 Weeks After Randomisation | Week 0, week 26 | Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | Week 0, week 26 | 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 Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | Week 0, week 26 | The results are based on the last in-trial value, which included the last available measurement in the in-trial period. |
| Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | 26 weeks after randomisation | The percentage of subjects who achieved the HbA1c target of \<7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders. |
| Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | 26 weeks after randomisation | The percentage of subjects who achieved the HbA1c target of \<7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders. |
| Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | 26 weeks after randomisation | The percentage of subjects who achieved the HbA1c target of \<7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders. |
| Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Week 0, week 26 | Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. |
| Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | 26 weeks after randomisation | Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \[140 mg/dL\] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders. |
| Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Week 0, week 26 | Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. 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) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile | Week 0, week 26 | The subject was instructed to perform a 7-9-7 SMPG point profile 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 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Week 0, week 26 | The subject was instructed to perform a 7-9-7 SMPG point profile 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 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Week 0, week 26 | The subject was instructed to perform a 7-9-7 SMPG point profile 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 (breakfast, lunch, main evening 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 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile | Week 0, week 26 | The subject was instructed to perform a 7-9-7 SMPG point profile 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. 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. 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 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Week 0, week 26 | The subject was instructed to perform 7-9-7 SMPG point profile on 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 following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period). |
| Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | 26 weeks after randomisation | Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \[140 mg/dL\] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders. |
| Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | 26 weeks after randomisation | The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L \[140 mg/dL\], had HbA1c \< 7.0% and had minimal weight gain (increase in body weight from baseline \<3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders. |
| Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | Week 0, week 26 | Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period). |
| Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Week 0, week 26 | The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 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 During 26 Weeks After Randomisation | Week 0 to week 26 (+7 days) | A treatment emergent adverse event (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 randomised treatment. |
| Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation | Week 0 to week 26 (+7 days) | A treatment emergent event 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 randomised treatment. |
| Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall | Week 0 to week 26 (+1 day) | ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia. NN Classification: * Severe:same as per ADA classification * Symptomatic blood glucose (BG) confirmed: PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * Asymptomatic BG confirmed:PG\<3.1 mmol/L without symptoms consistent with hypoglycaemia * Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * BG confirmed:PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period. |
| Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Week 0 to week 26 (+1 day) | ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: * Severe: same as per ADA classification * Symptomatic BG confirmed: PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * Asymptomatic BG confirmed: PG\<3.1 mmol/L without symptoms consistent with hypoglycaemia * Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia * BG confirmed: PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive. |
| Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Week 0 to week 26 (+1 day) | ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: * Severe: same as per ADA classification * Symptomatic BG confirmed: PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * Asymptomatic BG confirmed: PG\<3.1 mmol/L without symptoms consistent with hypoglycaemia * Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia * BG confirmed: PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Unclassifiable Results represent total number of hypoglycaemic episodes related to meals. |
| Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Week 0, week 26 | The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period. |
| Change From Baseline in Blood Pressure 26 Weeks After Randomisation | Week 0, week 26 | Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Pulse 26 Weeks After Randomisation | Week 0, week 26 | Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0, week 26 | The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Week 0, week 26 | The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Erythrocytes 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Haematocrit 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Haemoglobin 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Leukocytes 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Thrombocytes 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Albumin 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Total Bilirubin 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Potassium 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Creatinine 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Total Protein 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation | Week 0, week 26 | Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period. |
| Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | Week 0, week 26 | The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). 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 Urinalysis (Protein) 26 Weeks After Randomisation | Week 0, week 26 | Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period. |
| Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0, week 26 | Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period. |
| Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation | Week 0, week 26 | Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T). |
| Change From Baseline in Body Weight 26 Weeks After Randomisation | Week 0, week 26 | 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 Body Mass Index 26 Weeks After Randomisation | Week 0, week 26 | 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 Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0, week 26 | Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period. |
Countries
Austria, Bulgaria, Canada, Germany, India, Israel, Italy, Japan, Puerto Rico, Russia, Serbia, Taiwan, United States
Participant flow
Recruitment details
The trial was conducted at 146 sites in 12 countries(number of sites indicates those that both screened and randomised subjects, unless otherwise noted)-Austria(4);Bulgaria(8); Canada(6); Germany(7); India(16); Israel(6); Italy(4); Japan(24); Russian Federation(10); Serbia(3); Taiwan(3); United States(55 sites screened/52 sites randomised subjects)
Pre-assignment details
Eligible subjects were enrolled in a 8-week run-in period (1108 subjects) where subjects were switched from previous insulin treatment to insulin degludec once daily,and NovoRapid®/NovoLog® as mealtime bolus insulin. The basal insulin treatment was optimised using treat-to-target approach. 83 subjects were run-in failures and 1025 were randomised.
Participants by arm
| Arm | Count |
|---|---|
| Faster Aspart (Meal) Bolus insulin: Participants received subcutaneous (s.c., into the abdominal wall) injections of faster-acting insulin aspart at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.
Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period. | 342 |
| Faster Aspart (Post) Bolus insulin: Participants received s.c. injections of faster-acting insulin aspart at mealtime (injecting the bolus insulin at the end of the meal but no later than 20 minutes after the start of the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.
Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period. | 341 |
| NovoRapid (Meal) After 8-week run-in period, subjects continued using mealtime insulin aspart (NovoRapid®/NovoLog®) s.c. injections at mealtime (0-2 minutes before the meal) during 26-week treatment period. Throughout the trial, the insulin was administered at each of the three main meals (i.e. breakfast, lunch and main evening meal). The insulin was titrated to the glycaemic target of pre-prandial and bedtime plasma glucose between 4.0-6.0 mmol/L (71-108 mg/dL) in a treat-to-target fashion.
Basal insulin: Participants continued insulin degludec once daily s.c. injections at the dose optimized during run-in period during 26-week treatment period. | 342 |
| Total | 1,025 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 0 | 1 |
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Unclassified | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 4 | 6 | 4 |
Baseline characteristics
| Characteristic | Faster Aspart (Meal) | Faster Aspart (Post) | NovoRapid (Meal) | Total |
|---|---|---|---|---|
| Age, Continuous | 41.48 years STANDARD_DEVIATION 14.42 | 41.02 years STANDARD_DEVIATION 14.59 | 40.77 years STANDARD_DEVIATION 14.22 | 41.09 years STANDARD_DEVIATION 14.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants | 8 Participants | 12 Participants | 33 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 329 Participants | 333 Participants | 330 Participants | 992 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Glycosylated hemoglobin (HbA1c) | 7.46 percentage of HbA1c STANDARD_DEVIATION 0.68 | 7.40 percentage of HbA1c STANDARD_DEVIATION 0.6 | 7.41 percentage of HbA1c STANDARD_DEVIATION 0.79 | 7.42 percentage of HbA1c STANDARD_DEVIATION 0.7 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Asian | 116 Participants | 131 Participants | 137 Participants | 384 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 6 Participants | 16 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 219 Participants | 206 Participants | 198 Participants | 623 Participants |
| Sex: Female, Male Female | 158 Participants | 155 Participants | 163 Participants | 476 Participants |
| Sex: Female, Male Male | 184 Participants | 186 Participants | 179 Participants | 549 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 342 | 0 / 341 | 0 / 342 |
| other Total, other adverse events | 154 / 342 | 152 / 341 | 161 / 342 |
| serious Total, serious adverse events | 20 / 342 | 17 / 341 | 17 / 342 |
Outcome results
Primary
Change From Baseline in HbA1c 26 Weeks After Randomisation
Change from baseline (week 0) in HbA1c was evaluated after 26 weeks of randomisation. The results are based on the last in-trial value, which included the last available measurement in the in-trial period. In-trial period: the observation period from date of randomisation until last trial-related subject-site contact.
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in HbA1c 26 Weeks After Randomisation | -0.12 percentage of HbA1c | Standard Deviation 0.64 |
| Faster Aspart (Post) | Change From Baseline in HbA1c 26 Weeks After Randomisation | 0.005 percentage of HbA1c | Standard Deviation 0.64 |
| NovoRapid (Meal) | Change From Baseline in HbA1c 26 Weeks After Randomisation | -0.09 percentage of HbA1c | Standard Deviation 0.65 |
Comparison: The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.p-value: <0.00195% CI: [-0.11, 0.07]ANOVA model after multiple imputation
Comparison: The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.p-value: <0.00195% CI: [0.004, 0.19]ANOVA model after multiple imputation
Comparison: The endpoint was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline HbA1c as a covariate.p-value: 0.63395% CI: [-0.11, 0.07]ANOVA model after multiple imputation
Secondary
Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination)
The physical examination parameters included head, ears, eyes, nose, throat, neck; respiratory system; cardiovascular system; gastrointestinal system including mouth; musculoskeletal system; central and peripheral nervous system; and skin. The examinations were measured as 'normal', 'abnormal, not clinically significant' (Abn, NCS) or 'abnormal, clinically significant' (Abn, CS). Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 results are based on the last on-treatment value (last value), which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number analysed=number of subjects with available data for physical examinations at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Abn, NCS | 15.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Abn, NCS | 2.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Normal | 97.4 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Abn, NCS | 2.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Normal | 83.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Abn, NCS | 15.5 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Abn, CS | 0.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Normal | 83.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Normal | 97.4 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Abn, CS | 0.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Normal | 99.7 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Abn, NCS | 0.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Normal | 99.1 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Abn, NCS | 0.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck:week 0-Normal | 95.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-week 0:Abn,NCS | 4.1 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck-week 0:Abn,CS | 0.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck-Last value:Normal | 95.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-Last value:Abn,NCS | 3.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-Last value:Abn,CS | 0.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Normal | 95.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Abn, NCS | 4.1 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Normal | 96.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Abn, NCS | 3.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Normal | 99.4 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Abn, NCS | 0.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Normal | 99.7 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Abn, NCS | 0.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Normal | 91.5 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Abn, NCS | 7.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Abn, CS | 1.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Normal | 91.5 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Abn, NCS | 7.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Abn, CS | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Normal | 99.4 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Abn, CS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Normal | 97.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Normal | 99.4 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Abn, NCS | 1.2 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Abn, CS | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Normal | 91.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck:week 0-Normal | 95.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Abn, NCS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-week 0:Abn,NCS | 3.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck-week 0:Abn,CS | 0.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck-Last value:Normal | 92.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Abn, CS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-Last value:Abn,NCS | 6.2 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-Last value:Abn,CS | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Abn, CS | 2.4 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Normal | 97.1 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Normal | 89.7 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Abn, NCS | 2.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Abn, NCS | 6.2 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Normal | 97.4 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Abn, NCS | 8.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Normal | 98.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Abn, NCS | 2.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Abn, NCS | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Abn, CS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Normal | 98.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Abn, NCS | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Abn, CS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Normal | 86.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Abn, NCS | 12.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Abn, CS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Abn, CS | 1.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Normal | 87.1 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Abn, NCS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Abn, NCS | 12.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Normal | 98.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Abn, CS | 0.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Abn, NCS | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Abn, NCS | 12.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Abn, NCS | 13.2 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Abn, CS | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Abn, CS | 1.2 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Normal | 97.7 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Normal | 98.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Normal | 99.1 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Abn, NCS | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Abn, NCS | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Normal | 99.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Abn, NCS | 2.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-Last value: Abn, CS | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Abn, NCS | 3.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Abn, CS | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck:week 0-Normal | 93.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Week 0: Abn, CS | 0.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Abn, NCS | 7.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-week 0:Abn,NCS | 5.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Abn, NCS | 0.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Normal | 98.2 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck-week 0:Abn,CS | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Normal | 92.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Normal | 97.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ears,eyes,nose,throat,neck-Last value:Normal | 94.1 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Abn, CS | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Last value: Normal | 86.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-Last value:Abn,NCS | 4.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-Last value: Abn, CS | 0.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Abn, NCS | 1.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Head,ear,eye,nose,throat,neck-Last value:Abn,CS | 1.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Abn, CS | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Abn, CS | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Normal | 96.2 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Cardiovascular system - Last value: Abn, CS | 0.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-Last value: Abn, NCS | 6.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Abn, NCS | 3.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Skin-week 0: Normal | 91.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Gastrointestinal system-week 0: Abn, NCS | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-week 0: Abn, CS | 0.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Nervous system - Week 0: Normal | 86.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Respiratory system-week 0: Abn, CS | 0.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline 26 Weeks After Randomisation in Clinical Evaluations (Physical Examination) | Musculoskeletal system-Last value: Normal | 95.3 percentage of subjects |
Secondary
Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | 0.22 ug/mL | Standard Deviation 2.23 |
| Faster Aspart (Post) | Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | -0.15 ug/mL | Standard Deviation 2.1 |
| NovoRapid (Meal) | Change From Baseline in 1,5-anhydroglucitol 26 Weeks After Randomisation | 0.22 ug/mL | Standard Deviation 2.25 |
Comparison: Change from baseline in 1,5-anhydroglucitol was analysed using an analysis of variance model after multiple imputation assuming treatment according to randomisation. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline 1,5-anhydroglucitol as a covariate.p-value: 0.92495% CI: [-0.31, 0.34]ANOVA model after multiple imputation
Secondary
Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test)
The 1-hour PPG increment was analysed based on the laboratory-measured values in the meal test, and was derived using the 1-hour PPG measurement minus the pre-prandial plasma glucose (PG). The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | -1.13 mmol/L | Standard Deviation 4.04 |
| Faster Aspart (Post) | Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | 1.04 mmol/L | Standard Deviation 3.53 |
| NovoRapid (Meal) | Change From Baseline in 1-hour Post Prandial Glucose (PPG) Increment 26 Weeks After Randomisation (Meal Test) | -0.15 mmol/L | Standard Deviation 3.78 |
Comparison: Change from baseline in postprandial glucose increment (meal test) is analysed using an analysis of variance model. The model includes treatment, region and bolus adjusting method at randomisation as factors, and baseline postprandial glucose increment as a covariate.p-value: <0.00195% CI: [-1.36, -0.45]ANOVA
Secondary
Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation
Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 3 hours | -0.12 mmol/L | Standard Deviation 5.2 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 2 hours | -0.41 mmol/L | Standard Deviation 5.17 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 30 min | -0.47 mmol/L | Standard Deviation 3.58 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 1 hour | -1.05 mmol/L | Standard Deviation 4.56 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 4 hours | 0.005 mmol/L | Standard Deviation 4.64 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 2 hours | 0.80 mmol/L | Standard Deviation 5.38 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 30 min | 1.31 mmol/L | Standard Deviation 3.52 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 1 hour | 1.39 mmol/L | Standard Deviation 4.44 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 3 hours | 0.93 mmol/L | Standard Deviation 5.06 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 4 hours | 0.83 mmol/L | Standard Deviation 4.59 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 4 hours | 0.53 mmol/L | Standard Deviation 4.6 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 3 hours | 0.51 mmol/L | Standard Deviation 5.33 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 30 min | 0.21 mmol/L | Standard Deviation 3.78 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 2 hours | 0.33 mmol/L | Standard Deviation 5.51 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG 26 Weeks After Randomisation | Change in PPG at 1 hour | 0.20 mmol/L | Standard Deviation 4.52 |
Secondary
Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation
Laboratory measured PG from the meal test was analysed for 30, 60, 120, 180, and 240 minutes PPG separately. The corresponding PPG increments were derived separately using each PPG measurement minus the pre-prandial PG. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 30 min | -0.55 mmol/L | Standard Deviation 2.55 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 3 hours | -0.20 mmol/L | Standard Deviation 4.89 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 2 hours | -0.47 mmol/L | Standard Deviation 4.74 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 4 hours | -0.10 mmol/L | Standard Deviation 4.47 |
| Faster Aspart (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 1 hour | -1.13 mmol/L | Standard Deviation 4.04 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 2 hours | 0.42 mmol/L | Standard Deviation 5.01 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 30 min | 0.94 mmol/L | Standard Deviation 2.47 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 1 hour | 1.04 mmol/L | Standard Deviation 3.53 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 3 hours | 0.55 mmol/L | Standard Deviation 4.95 |
| Faster Aspart (Post) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 4 hours | 0.45 mmol/L | Standard Deviation 4.44 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 4 hours | 0.16 mmol/L | Standard Deviation 4.63 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 3 hours | 0.11 mmol/L | Standard Deviation 5.32 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 30 min | -0.14 mmol/L | Standard Deviation 2.63 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 2 hours | -0.01 mmol/L | Standard Deviation 5.15 |
| NovoRapid (Meal) | Change From Baseline in 30- Min, 1- Hour, 2- Hour, 3- Hour and 4- Hour PPG Increment 26 Weeks After Randomisation | Change in PPG increment at 1 hour | -0.15 mmol/L | Standard Deviation 3.78 |
Secondary
Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile
The subject was instructed to perform a 7-9-7 SMPG point profile 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: Week 0, week 26
Population: Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile | -0.304 mmol/L | Standard Deviation 1.928 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile | -0.231 mmol/L | Standard Deviation 1.846 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point Self-measured Plasma Glucose (SMPG) 26 Weeks After Randomisation: Mean of the 7-9-7-point Profile | -0.309 mmol/L | Standard Deviation 2.06 |
Secondary
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements
The subject was instructed to perform 7-9-7 SMPG point profile on 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 following day. Change from baseline in nocturnal PG values (nocturnal increments) was assessed by considering differences between PG values available at bedtime, at 4 a.m and the before breakfast value the following day: (04:00 PG value minus at bedtime PG value), (before breakfast PG value minus at bedtime PG value) and (before breakfast PG value minus 04:00 PG value). Results are based on the last in-trial value (the last available measurement in the in-trial period).
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-bedtime to breakfast | 0.86 mmol/L | Standard Deviation 6.21 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-bedtime to 04:00 | 0.14 mmol/L | Standard Deviation 5.66 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-04:00 to breakfast | 0.78 mmol/L | Standard Deviation 4.95 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-bedtime to breakfast | 0.93 mmol/L | Standard Deviation 6.24 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-bedtime to 04:00 | 0.19 mmol/L | Standard Deviation 6.41 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-04:00 to breakfast | 1.01 mmol/L | Standard Deviation 4.12 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-bedtime to 04:00 | 0.45 mmol/L | Standard Deviation 5.55 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-04:00 to breakfast | -0.02 mmol/L | Standard Deviation 4.17 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Change in the Nocturnal Self-measured Plasma Glucose Measurements | Change in nocturnal increment-bedtime to breakfast | 0.33 mmol/L | Standard Deviation 5.71 |
Secondary
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile
The subject was instructed to perform a 7-9-7 SMPG point profile 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. 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. The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis.
| Arm | Measure | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile | 0.876 ratio | Geometric Coefficient of Variation 47.49 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile | 0.875 ratio | Geometric Coefficient of Variation 40.293 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: Fluctuation in 7-9-7-point Profile | 0.890 ratio | Geometric Coefficient of Variation 41.978 |
Secondary
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal)
The subject was instructed to perform a 7-9-7 SMPG point profile 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 (breakfast, lunch, main evening 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: Week 0, week 26
Population: Analysis was based on FAS. Number of analysed=subject with data available data for PPG values and the PG value before the meal (breakfast, lunch, main evening meal).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment breakfast | -1.14 mmol/L | Standard Deviation 3.64 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment lunch | -0.67 mmol/L | Standard Deviation 3.2 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment main evening meal | -0.29 mmol/L | Standard Deviation 3.7 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment all meals | -0.72 mmol/L | Standard Deviation 2.06 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment all meals | 0.08 mmol/L | Standard Deviation 1.98 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment breakfast | 0.06 mmol/L | Standard Deviation 3.51 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment main evening meal | 0.34 mmol/L | Standard Deviation 3.54 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment lunch | -0.08 mmol/L | Standard Deviation 3.1 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment all meals | -0.02 mmol/L | Standard Deviation 2.01 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment lunch | -0.004 mmol/L | Standard Deviation 3.31 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment main evening meal | 0.26 mmol/L | Standard Deviation 3.49 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG Increment (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG increment breakfast | -0.30 mmol/L | Standard Deviation 3.16 |
Secondary
Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal)
The subject was instructed to perform a 7-9-7 SMPG point profile 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: Week 0, week 26
Population: Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG breakfast | -0.83 mmol/L | Standard Deviation 3.34 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG lunch | -0.59 mmol/L | Standard Deviation 3.04 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG main evening meal | -0.53 mmol/L | Standard Deviation 3.55 |
| Faster Aspart (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG all meals | -0.65 mmol/L | Standard Deviation 2.26 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG all meals | -0.004 mmol/L | Standard Deviation 2.19 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG breakfast | -0.03 mmol/L | Standard Deviation 3.3 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG main evening meal | -0.01 mmol/L | Standard Deviation 3.56 |
| Faster Aspart (Post) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG lunch | 0.06 mmol/L | Standard Deviation 2.98 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG all meals | -0.25 mmol/L | Standard Deviation 2.33 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG lunch | -0.33 mmol/L | Standard Deviation 3.38 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG main evening meal | -0.14 mmol/L | Standard Deviation 3.22 |
| NovoRapid (Meal) | Change From Baseline in 7-9-7-point SMPG 26 Weeks After Randomisation: PPG (Mean, Breakfast, Lunch, Main Evening Meal) | Change in PPG breakfast | -0.31 mmol/L | Standard Deviation 3.18 |
Secondary
Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alanine aminotransferase measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation | 1.3 U/L | Standard Deviation 10.1 |
| Faster Aspart (Post) | Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation | 0.9 U/L | Standard Deviation 9 |
| NovoRapid (Meal) | Change From Baseline in Alanine Aminotransferase 26 Weeks After Randomisation | 0.6 U/L | Standard Deviation 11.6 |
Secondary
Change From Baseline in Albumin 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for albumin measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Albumin 26 Weeks After Randomisation | -0.02 g/dL | Standard Deviation 0.25 |
| Faster Aspart (Post) | Change From Baseline in Albumin 26 Weeks After Randomisation | -0.05 g/dL | Standard Deviation 0.25 |
| NovoRapid (Meal) | Change From Baseline in Albumin 26 Weeks After Randomisation | -0.03 g/dL | Standard Deviation 0.25 |
Secondary
Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alkaline phosphatase measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation | 2.1 U/L | Standard Deviation 18.9 |
| Faster Aspart (Post) | Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation | 1.4 U/L | Standard Deviation 12.3 |
| NovoRapid (Meal) | Change From Baseline in Alkaline Phosphatase 26 Weeks After Randomisation | -0.2 U/L | Standard Deviation 14.4 |
Secondary
Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation
Insulin aspart antibody titres (antibodies specific for insulin aspart and those cross-reacting with human insulin) measured at baseline and at 26 weeks. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period. Anti-insulin aspart antibody was measured as % bound radioactivity-labelled insulin aspart/Total added radioactivity-labelled insulin aspart (%B/T).
Time frame: Week 0, week 26
Population: Analysis was based on the SAS. Number analysed=number of subjects with available data for anti-insulin aspart antibody.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation | Anti-insulin aspart specific antibodies | 0.033 % B/T | Standard Deviation 0.777 |
| Faster Aspart (Meal) | Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation | Cross-reacting to human insulin | -0.972 % B/T | Standard Deviation 6.028 |
| Faster Aspart (Post) | Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation | Anti-insulin aspart specific antibodies | -0.027 % B/T | Standard Deviation 1.077 |
| Faster Aspart (Post) | Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation | Cross-reacting to human insulin | -1.799 % B/T | Standard Deviation 6.812 |
| NovoRapid (Meal) | Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation | Anti-insulin aspart specific antibodies | -0.013 % B/T | Standard Deviation 1.568 |
| NovoRapid (Meal) | Change From Baseline in Anti-insulin Aspart (Specific and Cross-reacting With Human Insulin) Antibody Development 26 Weeks After Randomisation | Cross-reacting to human insulin | -1.427 % B/T | Standard Deviation 5.527 |
Secondary
Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for aspartate aminotransferase measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation | -0.0 U/L | Standard Deviation 9.5 |
| Faster Aspart (Post) | Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation | -0.1 U/L | Standard Deviation 9.4 |
| NovoRapid (Meal) | Change From Baseline in Aspartate Aminotransferase 26 Weeks After Randomisation | -0.3 U/L | Standard Deviation 13.3 |
Secondary
Change From Baseline in Blood Pressure 26 Weeks After Randomisation
Change from baseline in systolic blood pressure and diastolic blood pressure 26 weeks after randomisation. Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number of subjects analysed=subjects with available data for blood pressure
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Blood Pressure 26 Weeks After Randomisation | Diastolic blood pressure | 0.5 mmHg | Standard Deviation 8.3 |
| Faster Aspart (Meal) | Change From Baseline in Blood Pressure 26 Weeks After Randomisation | Systolic blood pressure | 0.6 mmHg | Standard Deviation 12.5 |
| Faster Aspart (Post) | Change From Baseline in Blood Pressure 26 Weeks After Randomisation | Diastolic blood pressure | 0.2 mmHg | Standard Deviation 7.8 |
| Faster Aspart (Post) | Change From Baseline in Blood Pressure 26 Weeks After Randomisation | Systolic blood pressure | 1.4 mmHg | Standard Deviation 10.8 |
| NovoRapid (Meal) | Change From Baseline in Blood Pressure 26 Weeks After Randomisation | Diastolic blood pressure | 0.8 mmHg | Standard Deviation 7.9 |
| NovoRapid (Meal) | Change From Baseline in Blood Pressure 26 Weeks After Randomisation | Systolic blood pressure | 0.8 mmHg | Standard Deviation 12.9 |
Secondary
Change From Baseline in Body Mass Index 26 Weeks After Randomisation
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number of subjects analysed=subject with data available for body mass index.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Body Mass Index 26 Weeks After Randomisation | 0.49 kg/m^2 | Standard Deviation 0.91 |
| Faster Aspart (Post) | Change From Baseline in Body Mass Index 26 Weeks After Randomisation | 0.39 kg/m^2 | Standard Deviation 1.02 |
| NovoRapid (Meal) | Change From Baseline in Body Mass Index 26 Weeks After Randomisation | 0.43 kg/m^2 | Standard Deviation 0.89 |
Secondary
Change From Baseline in Body Weight 26 Weeks After Randomisation
The results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number of subjects analysed=subject with data available for body weight.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Body Weight 26 Weeks After Randomisation | 1.43 kg | Standard Deviation 2.66 |
| Faster Aspart (Post) | Change From Baseline in Body Weight 26 Weeks After Randomisation | 1.14 kg | Standard Deviation 2.95 |
| NovoRapid (Meal) | Change From Baseline in Body Weight 26 Weeks After Randomisation | 1.24 kg | Standard Deviation 2.6 |
Secondary
Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation
The electrocardiogram was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' physical examinations at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number analysed=number of subjects with available data for electrocardiogram at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Normal | 80.7 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Abn, NCS | 19.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Normal | 80.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Abn, NCS | 19.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Abn, CS | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Abn, CS | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Normal | 81.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Normal | 84.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Abn, NCS | 15.1 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Abn, NCS | 17.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Abn, CS | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Abn, NCS | 15.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Abn, CS | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Abn, CS | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Normal | 82.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Week 0: Normal | 84.2 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Electrocardiogram) 26 Weeks After Randomisation | Last on-treatment value: Abn, NCS | 17.1 percentage of subjects |
Secondary
Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation
The result of the fundus photography/dilated fundoscopy was interpreted by the investigator into following categories: Normal; Abn, NCS; Abnormal, CS. Reported results are percentage of subjects with 'normal', 'Abn, NCS' and 'Abn, CS' fundoscopy/fundus photography results at week 0 and week 26. Week 26 data are based on the last on-treatment value which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number analysed=number of subjects with available data for fundoscopy/fundus photography at specified timepoints.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Normal | 65.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Abn, NCS | 26.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Abn, CS | 7.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Normal | 62.5 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Abn, NCS | 29.7 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Abn, CS | 7.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Normal | 65.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Abn, NCS | 27.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Abn, CS | 7.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Normal | 64.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Abn, NCS | 29.1 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Abn, CS | 6.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Abn, CS | 9.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Normal | 68.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Normal | 68.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Abn, CS | 8.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Abn, NCS | 23.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Abn, CS | 9.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Abn, NCS | 22.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Abn, CS | 8.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Abn, NCS | 22.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Abn, NCS | 21.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Normal | 69.4 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Normal | 67.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Normal | 69.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Abn, NCS | 21.1 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Normal | 68.7 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Last on-treatment value: Abn, CS | 9.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Normal | 67.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Abn, NCS | 25.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Abn, NCS | 22.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Normal | 69.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Abn, NCS | 23.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Week 0: Abn, CS | 7.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Left eye-Week 0: Abn, CS | 7.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Clinical Evaluation (Fundoscopy/Fundus Photography) 26 Weeks After Randomisation | Right eye-Last on-treatment value: Abn, CS | 8.7 percentage of subjects |
Secondary
Change From Baseline in Creatinine 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for creatinine measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Creatinine 26 Weeks After Randomisation | 2.0 umol/L | Standard Deviation 8.8 |
| Faster Aspart (Post) | Change From Baseline in Creatinine 26 Weeks After Randomisation | 1.8 umol/L | Standard Deviation 7.5 |
| NovoRapid (Meal) | Change From Baseline in Creatinine 26 Weeks After Randomisation | 1.8 umol/L | Standard Deviation 15.6 |
Secondary
Change From Baseline in Erythrocytes 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for erythrocytes measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Erythrocytes 26 Weeks After Randomisation | -0.01 number of erythrocytes 10^12/L | Standard Deviation 0.24 |
| Faster Aspart (Post) | Change From Baseline in Erythrocytes 26 Weeks After Randomisation | -0.03 number of erythrocytes 10^12/L | Standard Deviation 0.26 |
| NovoRapid (Meal) | Change From Baseline in Erythrocytes 26 Weeks After Randomisation | -0.02 number of erythrocytes 10^12/L | Standard Deviation 0.26 |
Secondary
Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation
The results are based on the last in-trial value, which included the last available measurement in the in-trial period.
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | 0.17 mmol/L | Standard Deviation 2.94 |
| Faster Aspart (Post) | Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | 0.44 mmol/L | Standard Deviation 3.29 |
| NovoRapid (Meal) | Change From Baseline in Fasting Plasma Glucose (FPG) 26 Weeks After Randomisation | 0.64 mmol/L | Standard Deviation 3.35 |
Secondary
Change From Baseline in Haematocrit 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haematocrit measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Haematocrit 26 Weeks After Randomisation | -0.48 percentage of red blood cells in blood | Standard Deviation 2.58 |
| Faster Aspart (Post) | Change From Baseline in Haematocrit 26 Weeks After Randomisation | -0.52 percentage of red blood cells in blood | Standard Deviation 2.41 |
| NovoRapid (Meal) | Change From Baseline in Haematocrit 26 Weeks After Randomisation | -0.57 percentage of red blood cells in blood | Standard Deviation 2.45 |
Secondary
Change From Baseline in Haemoglobin 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haemoglobin measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Haemoglobin 26 Weeks After Randomisation | -0.04 mmol/L | Standard Deviation 0.51 |
| Faster Aspart (Post) | Change From Baseline in Haemoglobin 26 Weeks After Randomisation | -0.04 mmol/L | Standard Deviation 0.46 |
| NovoRapid (Meal) | Change From Baseline in Haemoglobin 26 Weeks After Randomisation | -0.05 mmol/L | Standard Deviation 0.5 |
Secondary
Change From Baseline in Leukocytes 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for leukocytes measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Leukocytes 26 Weeks After Randomisation | -0.17 Number of leukocytes 10^9/L | Standard Deviation 1.63 |
| Faster Aspart (Post) | Change From Baseline in Leukocytes 26 Weeks After Randomisation | -0.03 Number of leukocytes 10^9/L | Standard Deviation 1.52 |
| NovoRapid (Meal) | Change From Baseline in Leukocytes 26 Weeks After Randomisation | -0.01 Number of leukocytes 10^9/L | Standard Deviation 1.46 |
Secondary
Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol)
Change from baseline in HDL cholesterol, LDL cholesterol and total cholesterol 26 weeks after randomization are represented as ratio to baseline values. The results are based on the last in-trial value (the last available measurement in the in-trial period).
Time frame: Week 0, week 26
Population: Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | LDL cholesterol | 1.025 ratio | Geometric Coefficient of Variation 20.067 |
| Faster Aspart (Meal) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | HDL cholesterol | 0.981 ratio | Geometric Coefficient of Variation 16.2 |
| Faster Aspart (Meal) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | Total cholesterol | 1.002 ratio | Geometric Coefficient of Variation 14.561 |
| Faster Aspart (Post) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | LDL cholesterol | 1.053 ratio | Geometric Coefficient of Variation 22.465 |
| Faster Aspart (Post) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | HDL cholesterol | 0.998 ratio | Geometric Coefficient of Variation 17.283 |
| Faster Aspart (Post) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | Total cholesterol | 1.030 ratio | Geometric Coefficient of Variation 15.789 |
| NovoRapid (Meal) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | HDL cholesterol | 0.999 ratio | Geometric Coefficient of Variation 33.056 |
| NovoRapid (Meal) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | Total cholesterol | 1.020 ratio | Geometric Coefficient of Variation 15.891 |
| NovoRapid (Meal) | Change From Baseline in Lipids-lipoproteins Profile 26 Weeks After Randomisation (Total Cholesterol, High Density Lipoproteins [HDL] Cholesterol, Low Density Lipoproteins [LDL] Cholesterol) | LDL cholesterol | 1.062 ratio | Geometric Coefficient of Variation 215.57 |
Secondary
Change From Baseline in Potassium 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for potassium measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Potassium 26 Weeks After Randomisation | 0.01 mmol/L | Standard Deviation 0.43 |
| Faster Aspart (Post) | Change From Baseline in Potassium 26 Weeks After Randomisation | 0.04 mmol/L | Standard Deviation 0.42 |
| NovoRapid (Meal) | Change From Baseline in Potassium 26 Weeks After Randomisation | 0.04 mmol/L | Standard Deviation 0.43 |
Secondary
Change From Baseline in Pulse 26 Weeks After Randomisation
Results are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number of subjects analysed=subjects with available data for pulse.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Pulse 26 Weeks After Randomisation | 0.0 beats/minute | Standard Deviation 8.8 |
| Faster Aspart (Post) | Change From Baseline in Pulse 26 Weeks After Randomisation | -0.7 beats/minute | Standard Deviation 9.3 |
| NovoRapid (Meal) | Change From Baseline in Pulse 26 Weeks After Randomisation | 0.7 beats/minute | Standard Deviation 8.3 |
Secondary
Change From Baseline in Thrombocytes 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for thrombocytes measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Thrombocytes 26 Weeks After Randomisation | -0.7 Number of thrombocytes 10^9/L | Standard Deviation 40 |
| Faster Aspart (Post) | Change From Baseline in Thrombocytes 26 Weeks After Randomisation | -2.0 Number of thrombocytes 10^9/L | Standard Deviation 36.3 |
| NovoRapid (Meal) | Change From Baseline in Thrombocytes 26 Weeks After Randomisation | -1.8 Number of thrombocytes 10^9/L | Standard Deviation 33.7 |
Secondary
Change From Baseline in Total Bilirubin 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total bilirubin measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Total Bilirubin 26 Weeks After Randomisation | -0.1 umol/L | Standard Deviation 3.3 |
| Faster Aspart (Post) | Change From Baseline in Total Bilirubin 26 Weeks After Randomisation | -0.2 umol/L | Standard Deviation 3.9 |
| NovoRapid (Meal) | Change From Baseline in Total Bilirubin 26 Weeks After Randomisation | -0.2 umol/L | Standard Deviation 3.3 |
Secondary
Change From Baseline in Total Protein 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total protein measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Total Protein 26 Weeks After Randomisation | 0.03 g/dL | Standard Deviation 0.4 |
| Faster Aspart (Post) | Change From Baseline in Total Protein 26 Weeks After Randomisation | 0.02 g/dL | Standard Deviation 0.37 |
| NovoRapid (Meal) | Change From Baseline in Total Protein 26 Weeks After Randomisation | -0.02 g/dL | Standard Deviation 0.36 |
Secondary
Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation
Presence of erythrocytes in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with erythrocytes values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number analysed=number of subjects with available data for erythrocytes values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Trace | 1.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 3+ | 0.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 2+ | 1.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 1.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: Negative | 93.5 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 0.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Negative | 95.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 1+ | 0.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: Trace | 2.7 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value:1+ | 1.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: Trace | 3.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value:1+ | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 2.1 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 1.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 2+ | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Negative | 93.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 3+ | 2.1 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Trace | 2.3 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: Negative | 91.7 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 1+ | 1.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: Negative | 91.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Trace | 3.2 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 1+ | 2.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 2+ | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: 3+ | 0.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Week 0: Negative | 93.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: Trace | 2.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value:1+ | 2.1 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 1.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Erythrocytes) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 1.8 percentage of subjects |
Secondary
Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation
Presence of ketone in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with ketone values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number analysed=number of subjects with available data for ketones values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Negative | 96.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Trace | 2.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 1+ | 1.8 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 2+ | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 3+ | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: Negative | 92.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: Trace | 5.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value:1+ | 2.1 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 0.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Negative | 97.1 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: Negative | 89.7 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: Trace | 6.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 3+ | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 0.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Trace | 1.8 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 2+ | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 1+ | 1.2 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value:1+ | 3.2 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 1+ | 1.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 2+ | 0.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value:1+ | 2.9 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: 3+ | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: Negative | 90.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Negative | 92.7 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: Trace | 6.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Week 0: Trace | 5.3 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Ketones) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 0.0 percentage of subjects |
Secondary
Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation
Presence of protein in urine was assessed by urine dipstick and categorised as: Negative, Positive, Trace, 1+, 2+, 3+. Change from baseline is represented in terms of percentage of patients with protein values at week 0 and week 26 (last on-treatment value). Last on-treatment value contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on SAS. Number analysed=number of subjects with available data for protein values.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Negative | 82.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Trace | 12.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 1+ | 4.4 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 2+ | 1.2 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 3+ | 0.3 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: Negative | 83.5 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: Trace | 8.6 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value:1+ | 5.9 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 1.5 percentage of subjects |
| Faster Aspart (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 0.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 0.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Negative | 79.5 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: Negative | 82.6 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: Trace | 10.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 3+ | 0.9 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 1.2 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Trace | 14.4 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 2+ | 1.2 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 1+ | 4.1 percentage of subjects |
| Faster Aspart (Post) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value:1+ | 4.7 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 1+ | 3.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 2+ | 2.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value:1+ | 6.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: 3+ | 0.6 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: Negative | 78.8 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value:Positive | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: 2+ | 2.1 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Negative | 80.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Positive | 0.0 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: Trace | 12.4 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Week 0: Trace | 13.5 percentage of subjects |
| NovoRapid (Meal) | Change From Baseline in Urinalysis (Protein) 26 Weeks After Randomisation | Last on-treatment value: 3+ | 0.3 percentage of subjects |
Secondary
Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation
Week 26 data are based on the last on-treatment value, which contains the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for urinary albumin and creatinine measurement.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Faster Aspart (Meal) | Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation | 0.636 mg/mmol | Standard Deviation 7.361 |
| Faster Aspart (Post) | Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation | -0.379 mg/mmol | Standard Deviation 11.095 |
| NovoRapid (Meal) | Change From Baseline in Urinary Albumin-to-creatinine Ratio 26 Weeks After Randomisation | 0.656 mg/mmol | Standard Deviation 12.739 |
Secondary
Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose)
The insulin doses were summarised descriptively at week 0 and week 26 both by meal type and as total daily dose (total daily and separately for each mealtime dose). Week 26 results are based on the last on-treatment value, which included the last available measurement in the on-treatment period.
Time frame: Week 0, week 26
Population: Analysis was based on safety analysis set (all subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for specified categories.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily bolus insulin dose: week 0 | 25.5 Units | Standard Deviation 15.4 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily bolus insulin dose: Last on-treatment value | 31.1 Units | Standard Deviation 19.4 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily basal insulin dose: week 0 | 25.3 Units | Standard Deviation 14.5 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily basal insulin dose: Last on-treatment value | 26.7 Units | Standard Deviation 16.6 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Total daily insulin dose: week 0 | 50.8 Units | Standard Deviation 26.1 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Total daily insulin dose: Last on-treatment value | 57.7 Units | Standard Deviation 31.4 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily breakfast bolus insulin dose: Last value | 8.8 Units | Standard Deviation 6.2 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily lunch bolus insulin dose: Last value | 10.5 Units | Standard Deviation 7 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily main evening meal bolus insulin: Last value | 11.9 Units | Standard Deviation 7.7 |
| Faster Aspart (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily other bolus insulin dose: Last value | 4.7 Units | Standard Deviation 5.1 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily main evening meal bolus insulin: Last value | 11.6 Units | Standard Deviation 7.4 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily bolus insulin dose: week 0 | 25.4 Units | Standard Deviation 14.3 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Total daily insulin dose: Last on-treatment value | 57.8 Units | Standard Deviation 30.2 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Total daily insulin dose: week 0 | 52.2 Units | Standard Deviation 25.2 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily bolus insulin dose: Last on-treatment value | 30.5 Units | Standard Deviation 18.9 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily other bolus insulin dose: Last value | 4.3 Units | Standard Deviation 3.5 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily lunch bolus insulin dose: Last value | 10.3 Units | Standard Deviation 6.9 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily basal insulin dose: week 0 | 26.7 Units | Standard Deviation 15.6 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily breakfast bolus insulin dose: Last value | 8.6 Units | Standard Deviation 6 |
| Faster Aspart (Post) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily basal insulin dose: Last on-treatment value | 27.3 Units | Standard Deviation 16.8 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily lunch bolus insulin dose: Last value | 11.2 Units | Standard Deviation 7.6 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily basal insulin dose: Last on-treatment value | 27.2 Units | Standard Deviation 17.3 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Total daily insulin dose: week 0 | 53.1 Units | Standard Deviation 25.9 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Total daily insulin dose: Last on-treatment value | 60.4 Units | Standard Deviation 34 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily main evening meal bolus insulin: Last value | 12.7 Units | Standard Deviation 9.1 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily breakfast bolus insulin dose: Last value | 9.5 Units | Standard Deviation 7.7 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily bolus insulin dose: week 0 | 26.6 Units | Standard Deviation 14.8 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily other bolus insulin dose: Last value | 4.2 Units | Standard Deviation 3.3 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily bolus insulin dose: Last on-treatment value | 33.5 Units | Standard Deviation 22.5 |
| NovoRapid (Meal) | Insulin Dose (Basal Insulin Dose, Total and Individual Meal Insulin Dose) | Daily basal insulin dose: week 0 | 26.2 Units | Standard Deviation 15 |
Secondary
Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive)
ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: * Severe: same as per ADA classification * Symptomatic BG confirmed: PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * Asymptomatic BG confirmed: PG\<3.1 mmol/L without symptoms consistent with hypoglycaemia * Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia * BG confirmed: PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Unclassifiable Results represent total number of hypoglycaemic episodes. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05:59 both inclusive.
Time frame: Week 0 to week 26 (+1 day)
Population: Analysis was based on SAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Daytime hypoglycaemic episodes | 14570 hypoglycaemic episodes |
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Nocturnal hypoglycaemic episodes | 1190 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Daytime hypoglycaemic episodes | 15379 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Nocturnal hypoglycaemic episodes | 1200 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Daytime hypoglycaemic episodes | 15257 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: Daytime and Nocturnal Hypoglycaemic Episodes (00:01-05:59 - Inclusive) | Nocturnal hypoglycaemic episodes | 1263 hypoglycaemic episodes |
Secondary
Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal
ADA classification includes following criteria: Severe, Documented symptomatic, Asymptomatic, Probable symptomatic, Pseudo-hypoglycaemia. NN Classification: * Severe: same as per ADA classification * Symptomatic BG confirmed: PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * Asymptomatic BG confirmed: PG\<3.1 mmol/L without symptoms consistent with hypoglycaemia * Severe or BG confirmed symptomatic: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/Lwith symptoms consistent with hypoglycaemia * BG confirmed: PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Severe or BG confirmed: severe according to the ADA classification or BG confirmed by PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Unclassifiable Results represent total number of hypoglycaemic episodes related to meals.
Time frame: Week 0 to week 26 (+1 day)
Population: Analysis was based on SAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 2 hours after meal | 1314 hypoglycaemic episodes |
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 2 (exclusive) to 3 hours (inclusive) | 1236 hypoglycaemic episodes |
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 1 (exclusive) to 2 hours (inclusive) | 690 hypoglycaemic episodes |
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 1 hour after meal | 624 hypoglycaemic episodes |
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 3 (exclusive) to 4 hours (inclusive) hours | 1370 hypoglycaemic episodes |
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 2 (exclusive) to 4 hours (inclusive) | 2606 hypoglycaemic episodes |
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 4 hours after meal | 3920 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 1 (exclusive) to 2 hours (inclusive) | 856 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 1 hour after meal | 614 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 2 hours after meal | 1470 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 4 hours after meal | 4794 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 2 (exclusive) to 3 hours (inclusive) | 1634 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 2 (exclusive) to 4 hours (inclusive) | 3324 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 3 (exclusive) to 4 hours (inclusive) hours | 1690 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 2 (exclusive) to 3 hours (inclusive) | 1302 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 2 hours after meal | 1224 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 3 (exclusive) to 4 hours (inclusive) hours | 1603 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 2 (exclusive) to 4 hours (inclusive) | 2905 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Between 1 (exclusive) to 2 hours (inclusive) | 765 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 4 hours after meal | 4129 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the ADA Definition and Novo Nordisk Definition During 26 Weeks After Randomisation: From Start of Meal Until 1,2, 4 Hours and From 2 Hours (Exclusive) to 4 Hours (Inclusive) After Start of Meal | Within 1 hour after meal | 459 hypoglycaemic episodes |
Secondary
Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall
ADA classification includes following criteria: Severe,Documented symptomatic,Asymptomatic,Probable symptomatic,Pseudo-hypoglycaemia. NN Classification: * Severe:same as per ADA classification * Symptomatic blood glucose (BG) confirmed: PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * Asymptomatic BG confirmed:PG\<3.1 mmol/L without symptoms consistent with hypoglycaemia * Severe or BG confirmed symptomatic:severe according to ADA classification or BG confirmed by PG\<3.1 mmol/L with symptoms consistent with hypoglycaemia * BG confirmed:PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Severe or BG confirmed:severe according to ADA classification or BG confirmed by PG\<3.1 mmol/L with or without symptoms consistent with hypoglycaemia * Unclassifiable Results represent total number of hypoglycaemic episodes. Treatment emergent episode: an event that has onset up to 1 day after last day of randomised treatment and excluding events occurring in run-in period.
Time frame: Week 0 to week 26 (+1 day)
Population: Analysis was based on SAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall | 15760 hypoglycaemic episodes |
| Faster Aspart (Post) | Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall | 16579 hypoglycaemic episodes |
| NovoRapid (Meal) | Number of Hypoglycaemic Episodes Classified Both According to the American Diabetes Association (ADA) Definition and Novo Nordisk (NN) Definition During 26 Weeks After Randomisation: Overall | 16520 hypoglycaemic episodes |
Secondary
Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation
A treatment emergent adverse event (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 randomised treatment.
Time frame: Week 0 to week 26 (+7 days)
Population: Analysis was based on SAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart (Meal) | Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation | 649 events |
| Faster Aspart (Post) | Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation | 656 events |
| NovoRapid (Meal) | Number of Treatment Emergent Adverse Events During 26 Weeks After Randomisation | 627 events |
Secondary
Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation
A treatment emergent event 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 randomised treatment.
Time frame: Week 0 to week 26 (+7 days)
Population: Analysis was based on SAS.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Faster Aspart (Meal) | Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation | 9 Injection site reactions |
| Faster Aspart (Post) | Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation | 12 Injection site reactions |
| NovoRapid (Meal) | Number of Treatment-emergent Injection Site Reactions During the 26 Weeks After Randomisation | 10 Injection site reactions |
Secondary
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation
The percentage of subjects who achieved the HbA1c target of \<7.0% 26 weeks after randomisation. Subjects without an HbA1c measurement at week 26 were treated as non-responders.
Time frame: 26 weeks after randomisation
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | Yes | 28.7 percentage of subjects |
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | No | 71.3 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | Yes | 28.2 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | No | 71.8 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | Yes | 32.7 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0%) 26 Weeks After Randomisation | No | 67.3 percentage of subjects |
Secondary
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation
The percentage of subjects who achieved the HbA1c target of \<7.0% without severe hypoglycaemia 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 were treated as non-responders.
Time frame: 26 weeks after randomisation
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | Yes | 25.7 percentage of subjects |
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | No | 74.3 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | Yes | 26.4 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | No | 73.6 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | Yes | 30.4 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia) 26 Weeks After Randomisation | No | 69.6 percentage of subjects |
Secondary
Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation
The percentage of subjects who achieved the HbA1c target of \<7.0% without severe hypoglycaemia and with minimal weight gain (defined as less than a 3% increase) 26 weeks after randomisation. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an HbA1c measurement at week 26 or without body weight measurement at week 26 were treated as non-responders.
Time frame: 26 weeks after randomisation
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | Yes | 16.4 percentage of subjects |
| Faster Aspart (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | No | 83.6 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | Yes | 17.9 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | No | 82.1 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | Yes | 19.3 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching HbA1c Targets (HbA1c < 7.0% Without Severe Hypoglycaemia and Minimal Weight Gain [<3.0%]) 26 Weeks After Randomisation | No | 80.7 percentage of subjects |
Secondary
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L
Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \[140 mg/dL\] 26 weeks after randomisation. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.
Time frame: 26 weeks after randomisation
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | Yes | 27.8 percentage of subjects |
| Faster Aspart (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | No | 72.2 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | Yes | 19.9 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | No | 80.1 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | Yes | 21.6 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L | No | 78.4 percentage of subjects |
Secondary
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia
The percentage of subjects who achieved overall mean 1 hour PPG ≤7.8 mmol/L \[140 mg/dL\], had HbA1c \< 7.0% and had minimal weight gain (increase in body weight from baseline \<3.0%) 26 weeks after randomisation, and without severe hypoglycaemic episodes. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG or an HbA1c value or a body weight at week 26 were treated as non-responders.
Time frame: 26 weeks after randomisation
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | Yes | 7.6 percentage of subjects |
| Faster Aspart (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | No | 92.4 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | Yes | 4.7 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | No | 95.3 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | Yes | 8.2 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L and HbA1c <7.0% and Minimal Weight Gain (<3.0%) Without Severe Hypoglycaemia | No | 91.8 percentage of subjects |
Secondary
Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia
Percentage of subjects achieving an overall mean 1-hour PPG ≤7.8 mmol/L \[140 mg/dL\] 26 weeks after randomisation without severe hypoglycaemia. Severe hypoglycaemia: An episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose concentrations may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration. Subjects without an overall mean 1-hour PPG at week 26 were treated as non-responders.
Time frame: 26 weeks after randomisation
Population: Analysis was based on FAS.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Faster Aspart (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | Yes | 24.6 percentage of subjects |
| Faster Aspart (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | No | 75.4 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | Yes | 18.8 percentage of subjects |
| Faster Aspart (Post) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | No | 81.2 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | Yes | 20.5 percentage of subjects |
| NovoRapid (Meal) | Percentage of Subjects Reaching PPG Target (Overall Mean of Daily PPG Measurements in SMPG) 26 Weeks After Randomisation: Overall PPG (1 Hour) ≤7.8 mmol/L Without Severe Hypoglycaemia | No | 79.5 percentage of subjects |