| Primary | Change From Baseline in HbA1c (%) | Change from baseline in HbA1c (%) after 26 weeks of treatment | The FAS included all randomised subjects. The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation "as randomised". | Posted | | Least Squares Mean | Standard Error | percentage change in HbA1c | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | IDegAsp BID | The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening). | | OG001 | IDeg OD+IAsp | The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.23± 0.13
- OG001-1.42± 0.12
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Change from baseline in FPG after 26 weeks of treatment | The FAS included all randomised subjects (2 subjects-baseline FPG not measured). The statistical evaluation of the FAS followed the ITT principle and subjects contributed to the evaluation "as randomised". | Posted | | Least Squares Mean | Standard Error | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | IDegAsp BID | The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening). | | OG001 | IDeg OD+IAsp | The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1. |
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| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes | According to the Novo Nordisk definition for confirmed hypoglycaemic episodes (severe hypoglycaemia and/or a measured Plasma Glucose (PG) <3.1 mmol/L(56 mg/dL)) | The safety Analysis Set (SAS): included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated". | Posted | | Number | | episodes | | During Weeks 0-26 | | | | ID | Title | Description |
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| OG000 | IDegAsp BID | The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening). | | OG001 | IDeg OD+IAsp | The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1. |
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| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes | According to the American Diabetes Association (ADA) definition following are the categories of hypoglycaemic episodes: Severe hypoglycaemia, Documented symptomatic hypoglycaemia, Asymptomatic hypoglycaemia, Probable symptomatic hypoglycaemia and Relative hypoglycaemia | The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated". | Posted | | Number | | episodes | | During Weeks 0-26 | | | | ID | Title | Description |
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| OG000 | IDegAsp BID | The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening). | | OG001 | IDeg OD+IAsp | The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1. |
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| Secondary | Number of Treatment Emergent Nocturnal (00:01-05:59 am) Confirmed Hypoglycaemic Episodes | Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m. | The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated". | Posted | | Number | | episodes | | Weeks 0-26 | | | | ID | Title | Description |
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| OG000 | IDegAsp BID | The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening). | | OG001 | IDeg OD+IAsp | The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1. |
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| Secondary | Incidence of Treatment Emergent Adverse Events (TEAE) | A TEAE was defined as an event that has onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment | The SAS included all subjects who received at least one dose of the investigational product or its comparator. Subjects in the safety set contributed to the evaluation "as treated". | Posted | | Number | | number of events | | Weeks 0-26 | | | | ID | Title | Description |
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| OG000 | IDegAsp BID | The subjects in this arm received insulin degludec/insulin aspart (IDegAsp) (100 U/mL, 3 mL prefilled pen PDS290) twice daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh either with breakfast and dinner or with lunch and dinner for 26 weeks. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without oral anti-diabetic drugs (OADs) (metformin, sulphonylurea (SU), glinide, dipeptidyl peptidase-4 (DPP-4) inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1 (screening). | | OG001 | IDeg OD+IAsp | The subjects in this arm received IDeg (100 U/mL, 3 mL prefilled pen PDS290) once daily, subcutaneously in the abdomen, upper arm (deltoid area) or thigh at any time of the day. The subjects in this arm also received IAsp ([NovoRapid®/NovoLog®], 100 U/mL, 3 mL, FlexPen®) with the main meals 2-4 times daily, subcutaneously (preferably into the abdominal wall) in accordance with local labelling. The subjects pre-study medication included a basal insulin regimen (insulin detemir; insulin glargine; insulin NPH) with or without OADs (metformin, SU, glinide, DPP-4 inhibitors, α-glucosidase-inhibitors), for at least 12 weeks prior to visit 1. |
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