| 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 is imputed using last observation carried forward (LOCF). | Posted | | Mean | Standard Deviation | percentage of glycosylated haemoglobin | | Week 0, Week 16 | | | | ID | Title | Description |
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| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. | | OG003 | IGlar | Insulin glargine (IGlar) was given subcutaneously once daily (OD) before bedtime in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. |
| | Units | Counts |
|---|
| Participants | - OG00061
- OG00160
- OG00262
- OG003
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| | Title | Denominators | Categories |
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| | | Title | Measurements |
|---|
| - OG000-1.26± 1.11
- OG001-1.28± 1.11
- OG002-1.46± 1.06
- OG003
|
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| |
| Secondary | Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) | 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 is imputed using last observation carried forward (LOCF). | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | |
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| Secondary | Rate of Major and Minor Hypoglycaemic Episodes | 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 |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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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 |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | |
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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 |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. |
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| Secondary | Laboratory Safety Parameters (Biochemistry): Alanine Aminotransferase (ALAT) | Mean values at 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. | Posted | | Mean | Standard Deviation | IU/L | | Week -4, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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| Secondary | Laboratory Safety Parameters (Biochemistry): Aspartate Aminotransferase (ASAT) | Mean values at 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. | Posted | | Mean | Standard Deviation | IU/L | | Week -4, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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| Secondary | Laboratory Safety Parameters (Biochemistry): Serum Creatinine | Mean values at 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. | Posted | | Mean | Standard Deviation | umol/L | | Week -4, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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| Secondary | Vital Signs: Diastolic Blood Pressure (BP) | Mean 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. | Posted | | Mean | Standard Deviation | mmHg | | Week 0, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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| Secondary | Vital Signs: Systolic Blood Pressure (BP) | Mean 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. | Posted | | Mean | Standard Deviation | mmHg | | Week 0, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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| Secondary | Vital Signs: Pulse | Mean 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. | Posted | | Mean | Standard Deviation | beats/minute | | Week 0, Week 16 | | | | ID | Title | Description |
|---|
| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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| Secondary | Physical Examination | Physical examination was performed at screening (Week -4), randomisation (Week 0) 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 0, Week 8, Week 16 | | | | ID | Title | Description |
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| OG000 | SIBA (D) | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL [1 dosing unit = 9 nmol], insulin degludec; formulation D) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 units (U)/day and individually adjusted. | | OG001 | SIBA (E) | Soluble Insulin Basal Analogue E (SIBA E, 600 nmol/mL (1 dosing unit = 6 nmol), insulin degludec; formulation E) was given subcutaneously once daily (OD) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were initiated at 10 U/day and individually adjusted. | | OG002 | SIBA (D) M, W, F | Soluble Insulin Basal Analogue D (SIBA D, 900 nmol/mL (1 dosing unit = 9 nmol), insulin degludec; formulation D) was given subcutaneously thrice weekly (Monday [M], Wednesday[W], Friday[F]) in the evening in combination with at least 1500 mg/day metformin (tablets) for 16 weeks. Insulin doses were were initiated at 20 U/day and individually adjusted. |
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