| 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. | Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c. | Posted | | Mean | Standard Deviation | percentage of HbA1c | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.12± 0.64
- OG0010.005± 0.64
- OG002-0.09± 0.65
|
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | ANOVA model after multiple imputation | | <0.001 | p-value from the 2-sided test for treatment difference evaluated at the 5% level | Treatment difference | -0.02 | | | 2-Sided | 95 | -0.11 | 0.07 | | | | | Non-Inferiority | Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Primary analysis: HbA1c non-inferiority of mealtime faster aspart versus mealtime NovoRapid®/NovoLog®. Non-inferiority of mealtime faster aspart was considered confirmed if the upper boundary of the two-sided 95% CI was below or equal to 0.4% |
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| 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. | Analysis was based on FAS. Number of subjects analysed=subject with data available for 1-hour PPG and pre-prandial PG. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on FAS. Number of subjects analysed=subject with data available for 1,5-anhydroglucitol. | Posted | | Mean | Standard Deviation | ug/mL | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | Analysis was based on FAS. Number of subjects analysed=subject with data available for HbA1c. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on FAS. | Posted | | Number | | percentage of subjects | | 26 weeks after randomisation | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on FAS. | Posted | | Number | | percentage of subjects | | 26 weeks after randomisation | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Faster Aspart (Post) |
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| 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. | Analysis was based on FAS. | Posted | | Number | | percentage of subjects | | 26 weeks after randomisation | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Analysis was based on FAS. Number of analysed=subject with data available for PPG at individual timepoints. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on FAS. Number of analysed=subject with data available for PPG and pre-prandial PG at individual timepoints. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
|
| 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. | Analysis was based on FAS. Number of analysed=subject with data available for 7-9-7 point profile. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| 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. | Analysis was based on FAS. Number of analysed=subject with data available data at three profiles: post-breakfast, post-lunch, post-main evening meal. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | 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). | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Analysis was based on FAS. Number of analysed=subjects who contributed to this analysis. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Analysis was based on FAS. Number of analysed=subjects with available data for nocturnal SMPG measurements. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Analysis was based on FAS. | Posted | | Number | | percentage of subjects | | 26 weeks after randomisation | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on FAS. | Posted | | Number | | percentage of subjects | | 26 weeks after randomisation | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 |
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| 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. | Analysis was based on FAS. | Posted | | Number | | percentage of subjects | | 26 weeks after randomisation | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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). | Analysis was based on FAS. Number analysed=number of subjects with available data for individual lipid parameter. | Posted | | Geometric Mean | Geometric Coefficient of Variation | ratio | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | 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. | Posted | | Mean | Standard Deviation | Units | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. | Posted | | Number | | events | | Week 0 to week 26 (+7 days) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. | Posted | | Number | | Injection site reactions | | Week 0 to week 26 (+7 days) | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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.
| Analysis was based on SAS. | Posted | | Number | | hypoglycaemic episodes | | Week 0 to week 26 (+1 day) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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.
| Analysis was based on SAS. | Posted | | Number | | hypoglycaemic episodes | | Week 0 to week 26 (+1 day) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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.
| Analysis was based on SAS. | Posted | | Number | | hypoglycaemic episodes | | Week 0 to week 26 (+1 day) | | | | ID | Title | Description |
|---|
| OG000 | 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. |
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| 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. | Analysis was based on SAS. Number analysed=number of subjects with available data for physical examinations at specified timepoints. | Posted | | Number | | percentage of subjects | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | |
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| 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. | Analysis was based on SAS. Number of subjects analysed=subjects with available data for blood pressure | Posted | | Mean | Standard Deviation | mmHg | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. Number of subjects analysed=subjects with available data for pulse. | Posted | | Mean | Standard Deviation | beats/minute | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. Number analysed=number of subjects with available data for electrocardiogram at specified timepoints. | Posted | | Number | | percentage of subjects | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. Number analysed=number of subjects with available data for fundoscopy/fundus photography at specified timepoints. | Posted | | Number | | percentage of subjects | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | Faster Aspart (Post) | |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for erythrocytes measurement. | Posted | | Mean | Standard Deviation | number of erythrocytes 10^12/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haematocrit measurement. | Posted | | Mean | Standard Deviation | percentage of red blood cells in blood | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for haemoglobin measurement. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for leukocytes measurement. | Posted | | Mean | Standard Deviation | Number of leukocytes 10^9/L | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for thrombocytes measurement. | Posted | | Mean | Standard Deviation | Number of thrombocytes 10^9/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alanine aminotransferase measurement. | Posted | | Mean | Standard Deviation | U/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for albumin measurement. | Posted | | Mean | Standard Deviation | g/dL | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for alkaline phosphatase measurement. | Posted | | Mean | Standard Deviation | U/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for aspartate aminotransferase measurement. | Posted | | Mean | Standard Deviation | U/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total bilirubin measurement. | Posted | | Mean | Standard Deviation | umol/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for potassium measurement. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for creatinine measurement. | Posted | | Mean | Standard Deviation | umol/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for total protein measurement. | Posted | | Mean | Standard Deviation | g/dL | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on the safety analysis set. Number of participants analysed=participants with available data for urinary albumin and creatinine measurement. | Posted | | Mean | Standard Deviation | mg/mmol | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. Number analysed=number of subjects with available data for ketones values. | Posted | | Number | | percentage of subjects | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. Number analysed=number of subjects with available data for protein values. | Posted | | Number | | percentage of subjects | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. Number analysed=number of subjects with available data for erythrocytes values. | Posted | | Number | | percentage of subjects | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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). | Analysis was based on the SAS. Number analysed=number of subjects with available data for anti-insulin aspart antibody. | Posted | | Mean | Standard Deviation | % B/T | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | Faster Aspart (Post) | |
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| 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. | Analysis was based on SAS. Number of subjects analysed=subject with data available for body weight. | Posted | | Mean | Standard Deviation | kg | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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| 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. | Analysis was based on SAS. Number of subjects analysed=subject with data available for body mass index. | Posted | | Mean | Standard Deviation | kg/m^2 | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | 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. | | OG001 | 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. |
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