| Primary | Time From Randomisation to Inadequate Glycaemic Control and Need for Treatment Intensification | Inadequate glycaemic control and need for treatment intensification was defined as a glycosylated haemoglobin (HbA1c) of 7.0% or greater at 2 consecutive visits from week 26, including week 26 if HbA1c was greater than or equal to 7% at week 12. Time from randomisation to inadequate glycaemic control and need for treatment intensification was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function. | FAS included all randomised participants. Number analyzed=participants in the specified category. | Posted | | Median | Inter-Quartile Range | Weeks | | Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| | | Title | Denominators | Categories |
|---|
| Baseline HbA1c <8.5% + Non-SU users | - ParticipantsOG000112
- ParticipantsOG001105
| |
| | 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 |
|---|
| Test for no treatment difference was based on using a stratified log-rank test where treatment, baseline HbA1c group and pre-trial OAD treatment group were included as strata in the model. | Stratified log-rank test | | <.0001 | | | | | | | | | | | | | | Other | | |
|
| Secondary | Time From Randomisation to HbA1c >6.5% at 2 Consecutive Visits | Time to HbA1c > 6.5% at 2 consecutive visits is defined as time from randomization to HbA1c > 6.5% at 2 consecutive planned scheduled visits from week 26 (including week 26 if HbA1c was > 6.5% at week 12). Time from randomisation to HbA1c >6.5% at 2 consecutive visits was analysed using a stratified log-rank test where treatment, baseline HbA1c group and previous OAD treatment were included as strata in the model. The variable "baseline HbA1c group" was a dichotomised baseline HbA1c variable with 2 categories: HbA1c < 8.5% or HbA1c ≥ 8.5% and the variable "previous OAD treatment" was a categorical variable with 2 categories: SU ± OAD(s) (SU users) or OAD(s) (Non-SU users). 25%, median (50%) and 75% percentiles for the cumulative distribution function were obtained from the Kaplan-Meier survival function. | FAS included all randomised participants. Number analyzed=participants with event. | Posted | | Median | Inter-Quartile Range | Weeks | | Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | |
|
| Secondary | Change in HbA1c | Change in HbA1c from baseline (week 0) to week 26 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Percentage of HbA1c | | Week 0, week 26 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Body Weight | Change in body weight from baseline (week 0) to week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Kilogram (kg) | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Insulin Dose | Insulin dose after 26 and 104 weeks of treatment is presented. | Safety analysis set (SAS) included all participants receiving at least 1 dose of the investigational product (IDegLira) or comparator (IGlar). 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Units | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Participants Who Achieved (Yes/no): HbA1c <7.0% | Percentage of participants who achieved (yes/no) HbA1c <7.0% at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Weight Gain | Percentage of participants who achieved (yes/no) HbA1c <7.0% without weight gain at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Participants Who Achieved (Yes/no): HbA1c <7.0% Without Treatment-emergent Severe or Blood Glucose (BG) Confirmed Symptomatic Hypoglycaemic Episodes | Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the American Diabetes Association (ADA) classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Participants Who Achieved (Yes/no): HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Severe or BG confirmed symptomatic hypoglycaemia was defined as an episode that was severe according to the ADA classification or BG confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c <7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Participants Who Achieved (Yes/no): HbA1c ≤6.5% | Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Weight Gain | Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes | Severe or BG confirmed symptomatic hypoglycaemia is defined as 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 symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Participants Who Achieved (Yes/no): HbA1c ≤6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes and Without Weight Gain | Severe or BG confirmed symptomatic hypoglycaemia is defined as 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 symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes and without weight gain at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Number | | Percentage of participants | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Change in FPG | Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | SMPG-9-point Profile (Individual Points in the Profile) | Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Self-measured plasma glucose (SMPG)-9-point profile (individual points in the profile) at week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in SMPG-mean 9-point Profile | Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean 9-point profile from baseline (week 0) to week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in SMPG-mean Postprandial Increment Over All Meals | Participants measured plasma glucose values using the blood glucose meter at 9 time points: before breakfast, 90 min after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 min after start of dinner, bedtime, at 4:00 am and before breakfast the following day. Change in SMPG-mean postprandial increment over all meals from baseline (week 0) to week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Blood Pressure (Systolic and Diastolic) | Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Millimeters of mercury (mmHg) | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting C-peptide | Change in fasting C-peptide (measured in nanomoles per liter [nmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of C-peptide | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting Human Insulin | Change in fasting human insulin (measured in picomoles per liter [pmol/L]) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of insulin | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting Total Cholesterol | Change in fasting total cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of total cholesterol | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting LDL-cholesterol | Change in fasting low density lipoprotein (LDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of LDL-cholesterol | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting HDL-cholesterol | Change in fasting high density lipoprotein (HDL)- cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of HDL-cholesterol | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting VLDL-cholesterol | Change in fasting very low density lipoprotein (VLDL)-cholesterol (measured in mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of VLDL-cholesterol | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting Triglycerides | Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of triglycerides | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Fasting Free Fatty Acids | Change in fasting free fatty acids (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Geometric Mean | Geometric Coefficient of Variation | Ratio of free fatty acids | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | Severe or BG confirmed symptomatic hypoglycaemia is defined as 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 symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Episodes | | Weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | Severe or BG confirmed symptomatic hypoglycaemia is defined as 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 symptoms consistent with hypoglycaemia. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Episodes | | Weeks 0-104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment | Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent hypoglycaemic episodes according to ADA during 26 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Episodes | | Weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment | Hypoglycaemic episodes (SMPG value ≤3.9 mmol/L (70 mg/dL)) were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment emergent hypoglycaemic episodes according to ADA during 104 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Episodes | | Weeks 0-104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | Severe or BG confirmed symptomatic hypoglycaemia is defined as 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 symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 26 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Episodes | | Weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | Severe or BG confirmed symptomatic hypoglycaemia is defined as 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 symptoms consistent with hypoglycaemia. Nocturnal hypoglycaemic episodes were episodes occurring between 00:01 and 05.59 both inclusive. Hypoglycaemic episodes were defined as treatment-emergent if the onset of the episode occurred on or after the first day of trial product administration, and no later than 7 calendar days after the last day on trial product. Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes during 104 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Episodes | | Weeks 0-104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Number of TEAEs During 26 Weeks of Treatment | An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A treatment emergent adverse event (TEAE) was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 26 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Adverse events | | Weeks 0-26 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
|
| Secondary | Number of TEAEs During 104 Weeks of Treatment | An adverse event is any untoward medical occurrence in a participant administered a product, and which does not necessarily have a causal relationship with this treatment. A TEAE was defined as an adverse event that had onset date on or after the first day of exposure to trial product and no later than 7 days after the last day of trial product. If the event had onset date before the first day of exposure on trial product and increased in severity during the treatment period and until 7 days after the last drug date, then this event was also considered as a TEAE. Number of TEAEs during 104 weeks of treatment is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. | Posted | | Number | | Adverse events | | Week 0 to week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Eye Examination Category | Fundus photography or a dilated fundoscopy was performed at baseline (within 12 weeks prior to week 0) and week 104. The investigator interpreted each eye's (left and right) results and categorised them as: normal, abnormal not clinically significant (NCS) or abnormal clinically significant (CS). Number of participants in each category at baseline and week 104 were presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Count of Participants | | Participants | | Baseline (within 12 weeks prior to week 0), week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | ECG Evaluation | The electrocardiogram (ECG) was assessed at baseline (within 2 weeks prior to week 0) and week 104. The investigator interpreted the results and categorised them as: normal, abnormal NCS or abnormal CS. Number of participants in each ECG category at baseline and week 104 are presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Count of Participants | | Participants | | Baseline (within 2 weeks prior to week 0), week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Urine Albumin/Creatinine Ratio | Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented. | SAS included all participants receiving at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Milligrams per millimole (mg/mmol) | | Week 0, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Pulse Rate | Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Beats per minute | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Biochemistry Parameter- Creatinine, Total Bilirubin | Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Micromoles per liter (umol/L) | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Biochemistry Parameter- Albumin | Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Grams per deciliter (g/dL) | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Biochemistry Parameters- ALP, ALT, AST, Lipase and Amylase | Change in biochemistry parameters- alkaline phosphatase (ALP), alanine aminotransferase (ALT), aspartate aminotransferase (AST), lipase and amylase from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Units per liter (U/L) | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Biochemistry Parameter- Sodium, Potassium and Calcium | Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | mmol/L | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Haematological Parameter- Haemoglobin | Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | g/dL | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Haematological Parameter- Haematocrit | Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Percentage of red blood cells | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Haematological Parameter- Erythrocytes | Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | Week 0, week 26, week 104 | | | | ID | Title | Description |
|---|
| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
| |
| Secondary | Change in Haematological Parameter- Thrombocytes and Leukocytes | Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Haematological Parameter- Eosinophils | Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Percentage of eosinophils | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Haematological Parameter- Neutrophils | Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Percentage of neutrophils | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Haematological Parameter- Basophils | Change in basophils from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Percentage of basophils | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Haematological Parameter- Monocytes | Change in monocytes from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Percentage of monocytes | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Haematological Parameter- Lymphocytes | Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Percentage of lymphocytes | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Calcitonin | The number of participants who reported low, normal and high levels of calcitonin in relation to reference ranges at baseline (week 0), week 26 and week 104 are presented. | SAS included all participants who received at least 1 dose of the investigational product or comparator. 'Number analyzed'=participants with available data. | Posted | | Count of Participants | | Participants | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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| Secondary | Change in Short Form Health Survey Version 2.0 (SF-36v2™, Acute Version) Health Survey: Scores From the 8 Domains and Summaries of the Physical Component Score (PCS) and the Mental Component Score (MCS) | SF-36 is a 36-item patient-reported survey of patient health that measures the participant's overall health-related quality of life (HRQoL). SF-36v2™ (acute version) questionnaire measured eight domains of functional health and well-being as well as two component summary scores (physical component summary (PCS) and mental component summary (MCS)). The scores 0-100 (where higher scores indicated a better HRQoL) from the SF-36 were converted to norm-based scores to enable a direct interpretation in relation to the distribution of the scores in the 2009 U.S. general population. A norm-based score of 50 corresponds to the mean score and 10 corresponds to the standard deviation of the 2009 U.S. general population. Change from baseline in the sub-domain scores and component summary (PCS and MCS) scores are presented. A positive change score indicates an improvement since baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). |
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| Secondary | Change in TRIM-D | Treatment related impact measures-diabetes (TRIM-D) was developed according to the FDA guidance from 2009 on development of new PRO measures. The questionnaire consists of 5 sub-domains, which are scored according to a 1-5 point scale with a higher score indicating a better health state (less negative impact). Sub-domain scores are calculated by summing across items in the same sub-domain, and the total score is calculated by summing scores from all the sub-domains. The highest possible summed score within a sub-domain ranges from 20 (compliance sub-domain) to 40 (psychological health sub-domain) points and the highest possible total score is 140 points. Change in TRIM-D total score from baseline (week 0) to week 26 and week 104 is presented. A positive change score indicates an improvement since baseline. | FAS included all randomised participants. 'Number analyzed'=participants with available data. | Posted | | Mean | Standard Deviation | Score on a scale | | Week 0, week 26, week 104 | | | | ID | Title | Description |
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| OG000 | Insulin Degludec/Liraglutide | Participants received s.c. injection of IDegLira once daily up to 104 weeks. Participants received 10 dose steps (10 units IDeg/0.36 mg liraglutide) initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. The maximum dose was 50 dose steps (50 units IDeg/1.8 mg liraglutide). | | OG001 | Insulin Glargine | Participants received s.c. injection of insulin glargine (IGlar) once daily up to 104 weeks. Participants received 10 units of IGlar initially. The dose was then escalated twice weekly until the FPG target between 4.0-5.0 mmol/L (72-90 mg/dL) was reached. |
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