| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c was evaluated after 24 weeks of treatment. Missing data was imputed using the last observation carried forward (LOCF) method. | FAS included all randomised subjects who were dosed and had any post randomisation data. | Posted | | Mean | Standard Deviation | Percentage (%) of HbA1c | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-1.66± 1.00
- OG001-1.52± 0.94
|
|
| | 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 |
|---|
| The analysis was based on a mixed-effect model for repeated measures including changes from baseline in HbA1c at visit 6, 10, 14, 18, 22 and 26 (in week 4, 8, 12, 16, 20 and 24, respectively). The model included treatment, strata and region as fixed factors, subject as random effect, baseline HbA1c as covariate and interaction between all fixed effects and visit, and between the covariate and visit. | Mixed model for repeated measurements | | 0.2601 | | Treatment difference at week 24 | -0.09 | | | 2-Sided | 95 | -0.23 | 0.06 | | | Treatment difference at week 24: BIAsp 30 (TID) - BIAsp 30 (BID). Number of subjects contributed to the statistical analysis: N=217 for BIAsp 30 (TID) and N=213 for BIAsp 30 (BID). | |
|
| Secondary | Proportion of Subjects Achieving HbA1c Below 7.0% | Percentage of subjects achieving HbA1c <7.0% (yes or no) was evaluated after 24 weeks of treatment. | FAS included all randomised subjects who were dosed and had any post randomisation data. | Posted | | Number | | Percentage (%) of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
|
| Secondary | Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe Hypoglycaemic Episodes. | Percentage of subjects achieving HbA1c <7.0% (yes or no) without severe hypoglycaemic episodes was evaluated after 24 weeks of treatment. Severe hypoglycaemia: Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose (PG) concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration. | FAS included all randomised subjects who were dosed and had any post randomisation data. | Posted | | Number | | Percentage (%) of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | |
|
| Secondary | Proportion of Subjects Achieving HbA1c Below 7.0% Without Severe or Blood Glucose (BG) Confirmed Hypoglycaemic Episodes (According to the Novo Nordisk Classification) | Percentage of subjects achieving HbA1c <7.0% (yes or no) without severe or BG confirmed hypoglycaemic episodes (according to the Novo Nordisk classification) was evaluated after 24 weeks of treatment. Severe or BG confirmed hypoglycaemia: an episode that is severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose (PG) value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia. Severe hypoglycaemia as per ADA: Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. PG concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration. | FAS included all randomised subjects who were dosed and had any post randomisation data. | Posted | | Number | | Percentage (%) of participants | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
|
| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes Classified According to the American Diabetes Association (ADA) Definition | ADA classification of hypoglycaemia:
- Severe:Episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. PG concentrations may not be available during event, but neurological recovery following return of PG to normal is considered sufficient evidence that the event was induced by low PG concentration
- Asymptomatic:Episode not accompanied by typical symptoms of hypoglycaemia, but with a measured PG concentration ≤3.9 mmol/L
- Documented symptomatic:Episode during which typical symptoms of hypoglycaemia are accompanied by a measured PG concentration ≤3.9 mmol/L
- Pseudo:Episode during which person with diabetes reports any of the typical symptoms of hypoglycaemia with measured PG concentration >3.9 mmol/L but approaching that level
- Probable symptomatic:Episode during which symptoms of hypoglycaemia are not accompanied by PG determination but that was presumably caused by a PG concentration ≤3.9 mmol/L
| Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Treatment emergent hypoglycaemic episodes were defined as the hypoglycaemic episodes, which occurred on or after the first day of trial product administration (in week 0), and no later than 7 days after the last day on trial product. | Posted | | Number | | Count of hypoglycaemic episodes | | Week 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
|
| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes Classified According to Novo Nordisk Definition | Treatment emergent hypoglycaemic episodes were defined as the hypoglycaemic episodes, which occurred on or after the first day of trial product administration (in week 0), and no later than 7 days after the last day on trial product. Novo Nordisk (NN) classification of hypoglycaemia:
- Severe hypoglycaemia: According to the ADA classification.
- Blood glucose (BG) confirmed hypoglycaemia: an episode that is BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
- Severe or BG confirmed hypoglycaemia: an episode that is severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with or without symptoms consistent with hypoglycaemia.
| Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). | Posted | | Number | | Count of hypoglycaemic episodes | | Week 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
|
| Secondary | Change From Baseline in FPG by Central Laboratory Analysis | Change from baseline in fasting plasma glucose (FPG) by central laboratory analysis was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
|
| Secondary | 7-point SMPG Profile | 7-point self-measured plasma glucose (SMPG) profiles was evaluated after 24 weeks of treatment. Subjects were instructed to perform the following SMPG measurements:
- Before breakfast.
- 120 minutes after the start of breakfast.
- Before lunch.
- 120 minutes after the start of lunch.
- Before main evening meal.
- 120 minutes after the start of main evening meal.
- At bedtime. Missing data was imputed using the LOCF method.
| FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points. | Posted | | Mean | Standard Deviation | mmol/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 |
|
| Secondary | 7-point SMPG Profiles: Change From Baseline in 2-hour PPG at Individual Meal (Breakfast, Lunch and Main Evening Meal) | Change from baseline in 2-hour postprandial glucose (PPG) at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | |
|
| Secondary | 7-point SMPG Profiles: Change From Baseline in PPG Increment at Individual Meal (Breakfast, Lunch and Main Evening Meal) | Change from baseline in PPG increment at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at specified time points. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | |
|
| Secondary | 7-point SMPG Profiles: Change From Baseline in Mean of 2-hour PPG Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal) | Change from baseline in mean of 2-hour PPG at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | |
|
| Secondary | 7-point SMPG Profiles: Change From Baseline in Mean of PPG Increment Over 3 Main Meals (Breakfast, Lunch and Main Evening Meal) | Change from baseline in mean of PPG increment at individual meal (breakfast, lunch and main evening meal) was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
|
| Secondary | 7-point SMPG Profiles: Change From Baseline in Mean of the 7-point Profile | Change from baseline in mean of the 7-point SMPG profiles was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
|
| Secondary | 7-point SMPG Profiles: Fluctuation in the 7-point Profile | Fluctuation in the 7-point SMPG profile was evaluated after 24 weeks of treatment. Fluctuation in 7-point SMPG profile was the average absolute difference to the mean of the profile of the 7-point SMPG measurements accumulated over the profile. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. Number analyzed = number of subjects contributed to the evaluation at the specified time point. | Posted | | Geometric Mean | Geometric Coefficient of Variation | mmol/L | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) |
|
| Secondary | Incidence of Treatment Emergent Adverse Events (TEAEs) | Incidence of TEAEs was recorded during 24 weeks of treatment. A TEAE was defined as an event that has onset date (or increase in severity) on or after the first day of exposure to trial product (in week 0) and no later than 7 days after the last day on trial product. | Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Number analyzed = number of subjects with corresponding numbers of TEAEs. | Posted | | Number | | Number of adverse events | | Week 0-24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | |
|
| Secondary | Total Daily Insulin Dose | Total daily insulin dose was the sum of doses given before breakfast and before main evening meal for the BID treatment group, and the sum of doses given before breakfast, before lunch and before main evening meal for the TID treatment group. Missing data was imputed using the LOCF method. | Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). Number analyzed = number of subjects contributed to the evaluation at the specified time point. | Posted | | Mean | Standard Deviation | Units (U) | | Week 1, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) |
|
| Secondary | Change From Baseline in Body Weight | Change from baseline in body weight was evaluated after 24 weeks of treatment. Missing data was imputed using the LOCF method. | Safety analysis set included all subjects who received at least one dose of investigational product (BIAsp 30). | Posted | | Mean | Standard Deviation | Kilogram (kg) | | Week 0, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. | | OG001 | Biphasic Insulin Aspart 30 (Twice Daily) | Subjects received BIAsp 30 BID; before breakfast and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
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| Secondary | Change From Baseline in Patient-reported Treatment Satisfaction as Assessed by the Diabetes Treatment Satisfaction Questionnaire (Status) (DTSQs) | Change from baseline in patient-reported treatment satisfaction (as assessed by the DTSQs) was evaluated after 24 weeks of treatment. The DTSQs is a self-completion questionnaire used to investigate the subject's treatment satisfaction. The DTSQ contained 8 questions, which were scored on a scale from 0 to 6. Out of 8 questions, 6 were related to the overall treatment satisfaction and 2 were related to glycaemic control (hypoglycaemia and hyperglycaemia). Results for the 6 questions relating to overall treatment satisfaction are presented together whereas the 2 questions relating to blood glucose are presented separately. For the overall treatment satisfaction, a higher score (0-36) was related to a better perception of treatment satisfaction. For hypoglycaemia and hyperglycaemia, a lower score (0-6) was related to a better blood glucose control. Missing data was imputed using the LOCF method. | FAS included all randomised subjects who were dosed and had any post randomisation data. | Posted | | Median | Full Range | Score on a scale | | Week 0, Week 24 | | | | ID | Title | Description |
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| OG000 | Biphasic Insulin Aspart 30 (Three Times Daily) | Subjects received BIAsp 30 TID; before breakfast, lunch and main evening meal for a duration of 24-week. BIAsp 30 was administered as s.c. injection according to the locally approved label and as described in the direction for use. The total daily dose of pre-trial basal insulin was transferred to the total daily starting dose of BIAsp 30 by unit-to-unit, which was distributed along meals at the investigator's discretion. During the 24-week treatment period, the insulin dose was individually titrated on a weekly basis for all subjects in order to achieve the pre-meal SMPG target of 4.4-6.1 mmol/L (80-110 mg/dL). Subjects continued with their stable, pre-trial dose of metformin (a total daily oral dose of >=1500 mg metformin or maximum tolerated dose) throughout the entire treatment period. |
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