| Primary | Change in Glycosylated Haemoglobin (HbA1c) From Baseline (Randomisation, Visit 2) | | Full analysis set included all the randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method. | Posted | | Least Squares Mean | Standard Error | percentage of glycosylated haemoglobin | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. | | OG001 | Liraglutide or Exenatide + OADs | Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-1.32± 0.05
- OG001-0.37± 0.07
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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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| | ANCOVA | | <0.001 | | Treatment contrast | -0.94 | | | 2-Sided | 95 | -1.11 | -0.78 | | | | | Superiority or Other | | |
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| Secondary | Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol) | Percentage of subjects achieving HbA1c below 7.0% after 26 weeks of treatment. | Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method. | Posted | | Number | | Percentage | | Week 26 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. | | OG001 | Liraglutide or Exenatide + OADs | Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern. |
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| Secondary | Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol) | Percentage of responders achieving pre-defined target for HbA1c - HbA1c ≤ 6.5% (48 mmol/mol). | Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method. | Posted | | Number | | Percentage | | Week 26 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. | | OG001 | Liraglutide or Exenatide + OADs | Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern. |
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| Secondary | Change From Baseline in Body Weight | Mean change in body weight after 26 weeks of treatment. | Full analysis set included all randomised subjects. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method. | Posted | | Mean | Standard Deviation | kg | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. | | OG001 | Liraglutide or Exenatide + OADs | Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern. |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) | Mean change in fasting plasma glucose from baseline, after 26 weeks of treatment. | Full analysis set included all randomised subjects. A total of 430 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. | | OG001 | Liraglutide or Exenatide + OADs | Subjects continued on their pre-trial GLP-1 receptor agonist treatment with subcutaneous (under the skin) liraglutide (Victoza®) or exenatide (Byetta®) in stable pre-trial dose without changing the frequency or dose throughout the trial. Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) without changing the frequency or dose throughout the trial, unless there was a safety concern. |
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| Secondary | Number of Severe or Minor Hypoglycaemic Episodes | Rate (events per 100 patient years of exposure) of treatment-emergent confirmed hypoglycaemic episodes. The pool of severe and minor hypoglycaemic episodes was referred to as confirmed hypoglycaemic episodes. Severe hypoglycaemia was categorised as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as an episode with symptoms consistent with hypoglycaemia with confirmation by blood glucose <2.8 mmol/L (50 mg/dL) or PG <3.1 mmol/L (56 mg/dL), and which was handled by the subject himself/herself, or any asymptomatic blood glucose value <2.8 mmol/L (50 mg/dL) or PG value <3.1 mmol/L (56 mg/dL). | Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. | Posted | | Number | | events per 100 patient years of exposure | | After 26 weeks of treatment | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. |
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| Secondary | Number of Adverse Events (AEs) | Rate (events per 100 exposure years) of treatment-emergent adverse events (an event that had onset date (or an increase in severity) on or after the first day of exposure to randomised treatment and no later than 7 days after the last day of randomised treatment) which occurred during the 26 weeks of treatment. | Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. | Posted | | Number | | events per 100 exposure years | | After 26 weeks of treatment | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. | | OG001 | Liraglutide or Exenatide + OADs | |
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| Secondary | Change From Baseline in Patient Reported Outcomes (PROs) Based on the Treatment Related Impact Measure - Diabetes (TRIM-D) | The patient related outcome is calculated based on TRIM-D questionnaire. The TRIM-D questionnaire consists of 5 sub-domains (treatment burden, daily life, diabetes management, compliance and psychological health), where each question is scored to a 1-5-point scale with a higher score indicating a better health state (less negative impact). Mean TRIM-D individual sub-domain scores and total score are later transformed to a 0-100 scale for analysis. The mean change in scores from baseline to 26 weeks for all the individual sub domains and total scores are presented here. | Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. |
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| Secondary | Change From Baseline in Patient Reported Outcomes (PROs) Based on Diabetes Treatment Satisfaction Questionnaire (DTSQ). | Mean change in diabetes treatment satisfaction questionnaire (DTSQs) scores from baseline. The scores ranged from 0 to 6. Higher total score on a 0-6 point scale indicates a general higher treatment satisfaction, whereas higher score on perceived frequency of hyperglycaemia and perceived frequency of hypoglycaemia indicate that blood glucose levels are out of the target range. | Full analysis set included all randomised subjects. A total of 436 subjects contributed to the analysis. Missing values (including intermittent missing values) were imputed using the last observation carried forward (LOCF) method. | Posted | | Mean | Standard Deviation | Scores on a scale | | Week 0, week 26 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide + Oral Anti Diabetic Drugs (OADs) | Subjects were treated with subcutaneous (under the skin) once daily (OD) insulin degludec/liraglutide. Treatment with insulin degludec/liraglutide was initiated at 16 dose steps containing 16 units of insulin degludec and 0.6 mg liraglutide. Adjustment of the insulin degludec/liraglutide dose was performed twice weekly based on the mean of 3 preceding daily fasting self measured plasma glucose (SMPG) values on 3 consecutive days. The aim was to achieve a fasting plasma glucose (FPG) target of 4.0-5.0 mmol/L (72-90 mg/dL) and the maximum allowed dose was 50 dose steps (50 units insulin degludec/1.8 mg liraglutide). Subjects also continued their pre-trial OADs (metformin±pioglitazone±SU) treatment without changing the frequency or dose throughout the trial, unless there was a safety concern. |
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