| Primary | Change in Glycosylated Haemoglobin (HbA1c) | Change from baseline in HbA1c after 16 weeks of treatment | The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). HbA1c values were missing for 2 subjects, hence did not contribute to the analysis | Posted | | Mean | Standard Deviation | percentage of glycosylated haemoglobin | | Week 0, Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.79± 1.11
- OG001-1.87± 0.91
- OG002-1.84± 0.93
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| Secondary | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | Estimate of the overall mean of SMPG after 16 weeks of treatment. Plasma glucose measured: before breakfast, 120 minutes after start of breakfast, before lunch, 120 minutes after start of lunch, before dinner, 120 minutes after start of dinner, before bedtime, at 4 am and before breakfast. | The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). For 2 subjects, mean SMPG values were missing. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. |
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| Secondary | Rate of Major and Minor Hypoglycaemic Episodes | Observed rate of major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. | The full analysis set (FAS) included all randomised subjects. | Posted | | Number | | Episodes/100 years of patient exposure | | Week 0 to Week 16 + 5 days follow up | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 | |
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| Secondary | Rate of Nocturnal Major and Minor Hypoglycaemic Episodes | Rate of nocturnal major and minor hypoglycaemic episodes per 100 patient years of exposure (PYE). Major if unable to treat her/himself. Minor if able to treat her/himself and plasma glucose below 3.1 mmol/L. Episodes were defined as nocturnal if the time of onset was between 23:00 (included) and 05:59 (included). | The full analysis set (FAS) included all randomised subjects. | Posted | | Number | | Episodes/100 years of patient exposure | | Week 0 to Week 16 + 5 days follow up | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 |
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| Secondary | Rate of Treatment Emergent Adverse Events (AEs) | Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect. | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. | Posted | | Number | | Events/100 years of patient exposure | | Week 0 to Week 16 + 5 days follow up | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. |
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| Secondary | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Laboratory values at screening (Week -4) and at Week 16 | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16. | Posted | | Mean | Standard Deviation | IU/L | | Week -4, Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 |
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| Secondary | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Laboratory values at screening (Week -4) and at Week 16 | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 3 subjects the laboratory values were missing at week -4. From the SAS, 54 (SIAC 30), 57 (SIAC 45) and 53 (BIAsp 30) subjects contributed to the analysis at week 16. | Posted | | Mean | Standard Deviation | IU/L | | Week -4, Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 |
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| Secondary | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Laboratory values at screening (Week -4) and at Week 16 | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. For 2 subjects the laboratory values were missing at week -4. From the SAS, 56 (SIAC 30), 57 (SIAC 45) and 56 (BIAsp 30) subjects contributed to the analysis at week 16. | Posted | | Mean | Standard Deviation | umol/L | | Week -4, Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 |
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| Secondary | Vital Signs: Diastolic Blood Pressure (BP) | Values at baseline (Week 0) and at Week 16 | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16. | Posted | | Mean | Standard Deviation | mmHg | | Week 0, Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 | |
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| Secondary | Vital Signs: Systolic Blood Pressure (BP) | Values at baseline (Week 0) and at Week 16 | The safety analysis set includes all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16. | Posted | | Mean | Standard Deviation | mmHg | | Week 0, Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. |
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| Secondary | Vital Signs: Pulse | Values at baseline (Week 0) and at Week 16 | The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator. From the SAS, 58 (SIAC 30), 56 (SIAC 45) and 58 (BIAsp 30) subjects contributed to the analysis at week 16. | Posted | | Mean | Standard Deviation | beats/minute | | Week 0, Week 16 | | | | ID | Title | Description |
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| OG000 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | BIAsp 30 | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. |
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| Secondary | Physical Examination | Physical examination was performed at screening (week -4), and after 8 and 16 weeks of treatment. If any new findings or deterioration in previous findings were observed during the trial, these were recorded as AEs and are therefore not presented separately as no analysis was performed. | | Posted | | | | | | Week -4, Week 8, Week 16 | | | | ID | Title | Description |
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| OG000 | BIAsp 30 | Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG001 | SIAC 30 (B) | Soluble Insulin Analogue Combination 30 (SIAC 30, 70 volume percent insulin degludec, 600 nmol/ml and 30 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. | | OG002 | SIAC 45 (B) | Soluble Insulin Analogue Combination 45 (SIAC 45, 55 volume percent insulin degludec, 600 nmol/ml and 45 volume percent insulin aspart, 600 nmol/ml [1 dosing unit = 6 nmol]); formulation B) was given subcutaneously twice daily before breakfast and dinner in combination with at least 1500 mg metformin (tablets) for 16 weeks. Insulin doses were individually adjusted. |
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