Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted globally. The aim of this trial is comparing glycaemic control and safety of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) as add-on therapy to SGLT2i (sodium-glucose cotransporter 2 inhibitors) in subjects with type 2 diabetes mellitus.
Interventions
DRUGinsulin degludec/liraglutide
IDegLira will be given subcutaneously ( s.c., under the skin) once daily.
DRUGinsulin glargine
IGlar will be given subcutaneously ( s.c., under the skin) once daily.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- Male or female, age at least 18 years at the time of signing informed consent - Subjects diagnosed (clinically) with type 2 diabetes mellitus - HbA1c 7.0-11.0% \[53-97 mmol/mol\] (both inclusive) by central laboratory analysis - Body mass index (BMI) equal to or above 20 kg/m\^2 and below 40 kg/m\^2 - Insulin naïve subjects; however short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as well as prior insulin treatment for gestational diabetes - A stable daily dose for at least 90 days prior to the day of screening of any SGLT2i in monotherapy or in combination with metformin ± DPP4i ± pioglitazone. Use of pioglitazone is not allowed in subjects treated with dapagliflozin
Exclusion criteria
- Receipt of any investigational medicinal product within 90 days prior to screening - Use of any OADs (other than SGLT2i in monotherapy or in combination with metformin or DPP4i or pioglitazone as described in the inclusion criteria) within 90 days prior to the day of screening - Use of glucagon-like peptide-1 (GLP-1) receptor agonist (e.g., exenatide or liraglutide) within 90 days prior to the day of screening - Acute decompensation of glycaemic control requiring immediate intensification of treatment to prevent severe metabolic dysregulation (e.g., diabetes ketoacidosis) in the previous 90 days prior to the day of the screening - Subjects presently classified as being in NYHA (New York Heart Association) Class III or IV1 - Renal impairment estimated Glomerular Filtration Rate 60 mL/min/1.73 m2 as per CKD-EPI (Chronic Kidney Disease Epidemiology Collaboration) - Impaired liver function, defined as ALT (alanine aminotransferase) equal to or above 2.5 times upper normal limit at screening - Known or suspected hypersensitivity to trial product(s) or related products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HbA1c (Glycosylated Haemoglobin) | Week 0, Week 26 | The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes | Week 0-26 | Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values \<3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia. |
| Insulin Dose, Total Daily Dose (U) | After 26 weeks | Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Change in Fasting Plasma Glucose (FPG) | Week 0, Week 26 | Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment. |
| Number of Treatment-emergent Adverse Events | Week 0-26 | Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. 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. |
| Responder (Yes/No) for HbA1c Below 7.0% | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets \<7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | After 26 weeks | The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Change From Baseline After 26 Weeks in Waist Circumference | After 26 weeks | Mean change from baseline in waist circumference after 26 weeks of randomised treatment. |
| Change From Baseline in Fasting Lipid Profile: Cholesterol | After 26 weeks | The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment. |
| Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) | After 26 weeks | The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. |
| Change in Body Weight | Week 0, Week 26 | The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product. |
| Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) | After 26 weeks | The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. |
| Change From Baseline in Fasting Lipid Profile: Triglycerides | After 26 weeks | The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment. |
| Change From Baseline in Fasting Lipid Profile: Free Fatty Acids | After 26 weeks | The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment. |
| Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | After 26 weeks | Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day. |
| Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile | After 26 weeks | Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day. |
| Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments | After 26 weeks | Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here. |
| Change From Baseline in Systolic Blood Pressure | After 26 weeks | Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment. |
| Change From Baseline in Diastolic Blood Pressure | After 26 weeks | Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment. |
| Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks | Week 0-26 | Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment. |
| Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Week 0-26 | American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG \>3.9 mmol/L with symptoms. 6) Unclassifiable. |
| Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | After 26 weeks | Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is \<= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). 4) Missing. |
| Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | After 26 weeks | Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is \<= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). 4) Missing. |
| Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate | After 26 weeks | Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment. |
| Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | After 26 weeks | The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here. |
| Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) | After 26 weeks | The patient reported outcomes are 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 domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here. |
| Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) | After 26 weeks | The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment. |
Countries
Argentina, Canada, Finland, Hungary, India, Russia, Slovakia, Slovenia, Spain, Switzerland, United States
Participant flow
Recruitment details
The trial was conducted at 74 sites in 11 countries as follows: Argentina (3), Canada (5), Finland (6), Hungary (5), India (8), Russian Federation (7), Slovakia (5), Slovenia (4), Spain (6), Switzerland (5) and United States (20).
Pre-assignment details
Subjects with type 2 diabetes mellitus on oral anti-diabetic drug (OAD) therapy with stable daily dose of sodium glucose co-transporter 2 inhibitors (SGLT2i) either as monotherapy or in combination with metformin ± dipeptidyl peptidase-4 inhibitors (DPP4i) ± pioglitazone according to locally approved label for at least 90 days prior to screening.
Participants by arm
| Arm | Count |
|---|---|
| IDegLira Subjects were administered with insulin degludec/liraglutide (IDegLira: 100 U/3.6 mg per mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IDegLira was supplied in a 3 mL prefilled PDS290 pen-injector with a fixed IDeg/liraglutide ratio of 100 U/3.6 mg per mL solution. IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg /0.36 mg liraglutide) and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values that were measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72 - 90 mg/dL\]). The maximum daily dose was 50 dose steps (50 U IDeg /1.8 mg Lira). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. | 210 |
| IGlar Subjects were administered with insulin glargine (IGlar: 100 U/mL) subcutaneously (s.c.) once daily for a duration of 26 weeks. IGlar was supplied in a 3 mL pre-filled Solostar® pen at 100 U/mL solution. IGlar treatment was initiated with the starting dose of 10 U and adjusted twice weekly on fixed days. Dose adjustment was based on the mean of three pre-breakfast self-measured plasma glucose (SMPG) values measured on the days of the titration and two days prior to the titration (target SMPG: 4.0-5.0 mmol/L \[72 - 90 mg/dL\]). Pre-trial OAD treatments were continued according to current local label. The randomised subjects would be on either SGLT2i monotherapy or SGLT2i ± metformin ± pioglitazone, this treatment was to be unchanged throughout the trial, unless there was a safety concern. | 210 |
| Total | 420 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Missing | 0 | 1 |
| Overall Study | Unclassified | 1 | 1 |
| Overall Study | Withdrawal by Subject | 5 | 1 |
Baseline characteristics
| Characteristic | IGlar | Total | IDegLira |
|---|---|---|---|
| Age, Continuous | 57.2 years STANDARD_DEVIATION 10.2 | 56.7 years STANDARD_DEVIATION 10.3 | 56.1 years STANDARD_DEVIATION 10.4 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 37 Participants | 68 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 173 Participants | 352 Participants | 179 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 35 Participants | 66 Participants | 31 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) White | 171 Participants | 346 Participants | 175 Participants |
| Sex: Female, Male Female | 84 Participants | 173 Participants | 89 Participants |
| Sex: Female, Male Male | 126 Participants | 247 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 209 | 0 / 210 |
| other Total, other adverse events | 49 / 209 | 45 / 210 |
| serious Total, serious adverse events | 6 / 209 | 7 / 210 |
Outcome results
Primary
Change in HbA1c (Glycosylated Haemoglobin)
The mean change from baseline (week 0) in HbA1c values evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: Week 0, Week 26
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change in HbA1c (Glycosylated Haemoglobin) | HbA1c (%) change from baseline to week 26 | -1.94 Percentage of glycosylated haemoglobin | Standard Deviation 0.95 |
| IDegLira | Change in HbA1c (Glycosylated Haemoglobin) | HbA1c (%) at baseline | 8.20 Percentage of glycosylated haemoglobin | Standard Deviation 0.93 |
| IGlar | Change in HbA1c (Glycosylated Haemoglobin) | HbA1c (%) change from baseline to week 26 | -1.68 Percentage of glycosylated haemoglobin | Standard Deviation 1.05 |
| IGlar | Change in HbA1c (Glycosylated Haemoglobin) | HbA1c (%) at baseline | 8.36 Percentage of glycosylated haemoglobin | Standard Deviation 1.08 |
Comparison: Analysis was based on ANCOVA model with treatment, pre-trial OAD, region as factors and baseline HbA1c as covariate. Data obtained after premature treatment discontinuation are included in the analysis. Missing data was imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation. The non-inferiority margin of 0.3 % was added to the end-of-treatment value for prematurely discontinued and withdrawn from trial IDegLira subjects.95% CI: [-0.48, -0.2]ANCOVA
Comparison: This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline value as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.95% CI: [-0.5, -0.21]ANCOVA
Secondary
Change From Baseline After 26 Weeks in Waist Circumference
Mean change from baseline in waist circumference after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change From Baseline After 26 Weeks in Waist Circumference | Waist circum. (cm) at baseline | 105.9 cm | Standard Deviation 12.7 |
| IDegLira | Change From Baseline After 26 Weeks in Waist Circumference | Waist circum. (cm) change from baseline to week 26 | -0.6 cm | Standard Deviation 4.6 |
| IGlar | Change From Baseline After 26 Weeks in Waist Circumference | Waist circum. (cm) at baseline | 104.7 cm | Standard Deviation 11.3 |
| IGlar | Change From Baseline After 26 Weeks in Waist Circumference | Waist circum. (cm) change from baseline to week 26 | 0.7 cm | Standard Deviation 3.9 |
Secondary
Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG)
Reported results are ECG findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is \<= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). 4) Missing.
Time frame: After 26 weeks
Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation as treated. Number analysed = Number of subjects contributed to the analysis at screening and week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Normal | 142 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Abnormal NCS | 66 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Abnormal CS | 1 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Missing | 0 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Normal | 134 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Abnormal NCS | 58 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Abnormal CS | 2 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Missing | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Missing | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Normal | 141 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Normal | 136 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Abnormal NCS | 69 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Abnormal CS | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Abnormal CS | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Week 26, Abnormal NCS | 64 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Electrocardiogram (ECG) | Screening, Missing | 0 Number of subjects |
Secondary
Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography
Reported results are fundus photography/fundoscopy (for both left and right eye) findings at screening and week 26 of randomised treatment. Since the values measured at the baseline (week 0) were not collected, the screening data (week -2, which is \<= 2 weeks before baseline) is presented here. The findings are categorised as: 1) Normal. 2) Abnormal (not clinically significant \[NCS\]). 3) Abnormal (clinically significant \[CS\]). 4) Missing.
Time frame: After 26 weeks
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation as treated. Number analysed = Number of subjects contributed to the analysis at screening and week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Normal) | 134 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Abnormal -NCS) | 68 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Abnormal-CS) | 7 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Missing) | 0 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Normal) | 123 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Abnormal -NCS) | 66 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Abnormal-CS) | 2 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Missing) | 0 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Normal) | 133 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Abnormal-NCS) | 69 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Abnormal- CS) | 7 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Missing) | 0 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Normal) | 120 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Abnormal-NCS) | 69 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Abnormal- CS) | 2 Number of subjects |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Missing) | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Missing) | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Normal) | 131 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Normal) | 133 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Abnormal -NCS) | 74 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Normal) | 127 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Abnormal-CS) | 4 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Abnormal-NCS) | 72 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Left eye (Missing) | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Abnormal- CS) | 4 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Normal) | 125 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Abnormal- CS) | 4 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Abnormal -NCS) | 68 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Right eye (Abnormal-NCS) | 66 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Abnormal-CS) | 4 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Screening, Right eye (Missing) | 0 Number of subjects |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Eye Examination: Fundoscopy/Fundus Photography | Week 26, Left eye (Missing) | 0 Number of subjects |
Secondary
Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate
Change from baseline (week 0) in pulse rate was evaluated after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation as treated. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate | Pulse (beats/min) at baseline | 76.1 Beats/minute | Standard Deviation 9.1 |
| IDegLira | Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate | Pulse (beats/min) change from baseline to week 26 | 2.0 Beats/minute | Standard Deviation 8.4 |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate | Pulse (beats/min) at baseline | 75.0 Beats/minute | Standard Deviation 9.5 |
| IGlar | Change From Baseline in Clinical Evaluation After 26 Weeks: Pulse Rate | Pulse (beats/min) change from baseline to week 26 | -0.4 Beats/minute | Standard Deviation 8.2 |
Secondary
Change From Baseline in Diastolic Blood Pressure
Change from baseline (week 0) in diastolic blood pressure was evaluated after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change From Baseline in Diastolic Blood Pressure | Diastolic (mmHg) at baseline | 79.4 mmHg | Standard Deviation 8 |
| IDegLira | Change From Baseline in Diastolic Blood Pressure | Diastolic (mmHg) change from baseline to week 26 | -1.2 mmHg | Standard Deviation 8.4 |
| IGlar | Change From Baseline in Diastolic Blood Pressure | Diastolic (mmHg) change from baseline to week 26 | -1.1 mmHg | Standard Deviation 8.3 |
| IGlar | Change From Baseline in Diastolic Blood Pressure | Diastolic (mmHg) at baseline | 78.9 mmHg | Standard Deviation 8.9 |
Secondary
Change From Baseline in Fasting Lipid Profile: Cholesterol
The values of total cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Fasting Lipid Profile: Cholesterol | Total cholesterol (mmol/L) at baseline | 4.42 mmol/L |
| IDegLira | Change From Baseline in Fasting Lipid Profile: Cholesterol | Total cholesterol (mmol/L) at week 26 | 4.27 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Cholesterol | Total cholesterol (mmol/L) at baseline | 4.45 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Cholesterol | Total cholesterol (mmol/L) at week 26 | 4.27 mmol/L |
Secondary
Change From Baseline in Fasting Lipid Profile: Free Fatty Acids
The values of free fatty acids from fasting lipid profile after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Fasting Lipid Profile: Free Fatty Acids | Free fatty acids (mmol/L) at baseline | 0.58 mmol/L |
| IDegLira | Change From Baseline in Fasting Lipid Profile: Free Fatty Acids | Free fatty acids (mmol/L) at week 26 | 0.38 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Free Fatty Acids | Free fatty acids (mmol/L) at baseline | 0.61 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Free Fatty Acids | Free fatty acids (mmol/L) at week 26 | 0.42 mmol/L |
Secondary
Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol)
The values of HDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) | HDL cholesterol (mmol/L) at baseline | 1.14 mmol/L |
| IDegLira | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) | HDL cholesterol (mmol/L) at week 26 | 1.17 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) | HDL cholesterol (mmol/L) at baseline | 1.14 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: High-density Lipoprotein Cholesterol (HDL Cholesterol) | HDL cholesterol (mmol/L) at week 26 | 1.17 mmol/L |
Secondary
Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol)
The values of LDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) | LDL cholesterol (mmol/L) at baseline | 2.28 mmol/L |
| IDegLira | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) | LDL cholesterol (mmol/L) at week 26 | 2.20 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) | LDL cholesterol (mmol/L) at baseline | 2.28 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Low-density Lipoprotein Cholesterol (LDL Cholesterol) | LDL cholesterol (mmol/L) at week 26 | 2.31 mmol/L |
Secondary
Change From Baseline in Fasting Lipid Profile: Triglycerides
The values of triglycerides from fasting lipid profile after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Fasting Lipid Profile: Triglycerides | Triglycerides (mmol/L) at baseline | 1.67 mmol/L |
| IDegLira | Change From Baseline in Fasting Lipid Profile: Triglycerides | Triglycerides (mmol/L) at week 26 | 1.55 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Triglycerides | Triglycerides (mmol/L) at baseline | 1.73 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Triglycerides | Triglycerides (mmol/L) at week 26 | 1.47 mmol/L |
Secondary
Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol)
The values of VLDL cholesterol from fasting lipid profile after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) | VLDL cholesterol (mmol/L) at baseline | 0.75 mmol/L |
| IDegLira | Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) | VLDL cholesterol (mmol/L) at week 26 | 0.70 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) | VLDL cholesterol (mmol/L) at baseline | 0.80 mmol/L |
| IGlar | Change From Baseline in Fasting Lipid Profile: Very-low-density Lipoprotein Cholesterol (VLDL Cholesterol) | VLDL cholesterol (mmol/L) at week 26 | 0.67 mmol/L |
Secondary
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2)
The Short Form (SF)-36v2™ patient reported outcomes (PRO) questionnaire was used to assess the subject's overall health related quality of life (HRQoL). PRO questionnaire (SF-36v2™) measured the HRQoL which contains 36 items covering 8 domains of physical and mental health status. The raw scale scores from the SF-36 were transformed to a 0-100 scale scores (where higher scores indicated a better health status) which is further converted to norm-based scores using a T-score transformation in order to obtain a direct interpretation in relation to the distribution of the scores in the 2009 reference population . The total/overall (SF-36v2™) scores for physical and mental health from baseline to week 26 are presented here.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline and week 26 for overall physical and mental scores.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall physical - Baseline | 51.3 Scores on a scale |
| IDegLira | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall physical - Week 26 | 53.2 Scores on a scale |
| IDegLira | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall mental - Baseline | 53.3 Scores on a scale |
| IDegLira | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall mental - Week 26 | 54.4 Scores on a scale |
| IGlar | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall mental - Week 26 | 54.4 Scores on a scale |
| IGlar | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall physical - Baseline | 51.5 Scores on a scale |
| IGlar | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall mental - Baseline | 53.3 Scores on a scale |
| IGlar | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Medical Outcomes Study 36-item Short Form (SF-36v2) | Overall physical - Week 26 | 54.6 Scores on a scale |
Secondary
Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D)
The patient reported outcomes are 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 domain scores and the total scores are later transformed to a 0-100 scale for analysis. Summary scores from baseline and week 26 for total/overall scores are presented here.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| IDegLira | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) | TRIM-D scores at baseline | 75.9 Scores on a scale |
| IDegLira | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) | TRIM-D scores at week 26 | 84.4 Scores on a scale |
| IGlar | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) | TRIM-D scores at baseline | 75.9 Scores on a scale |
| IGlar | Change From Baseline in Patient Reported Outcomes (PROs) After 26 Weeks: Summary Scores of Treatment Related Impact Measure for Diabetes (TRIM-D) | TRIM-D scores at week 26 | 83.9 Scores on a scale |
Secondary
Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile
Change in mean of the 9-point profile SMPG was evaluated after 26 weeks of randomised treatment. 9-point profile SMPG was measured at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile | Mean 9-point SMPG (mmol/L) at baseline | 9.98 mmol/L | Standard Deviation 2.17 |
| IDegLira | Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile | Mean 9-point SMPG change from baseline to week 26 | -3.47 mmol/L | Standard Deviation 2.01 |
| IGlar | Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile | Mean 9-point SMPG (mmol/L) at baseline | 10.06 mmol/L | Standard Deviation 2.04 |
| IGlar | Change From Baseline in Self-measured Plasma Glucose (SMPG) 9-point Profile: Mean of the 9-point Profile | Mean 9-point SMPG change from baseline to week 26 | -2.98 mmol/L | Standard Deviation 1.91 |
Secondary
Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments
Mean prandial plasma glucose increments for each meal (from before meal to 90 min after breakfast, lunch and dinner) was evaluated after 26 weeks of randomised treatment. The mean increment over all meals was derived as the mean of all available meal increments are presented here.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments | Baseline | 2.38 mmol/L | Standard Deviation 1.73 |
| IDegLira | Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments | Change from baseline to week 26 | -0.86 mmol/L | Standard Deviation 1.95 |
| IGlar | Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments | Baseline | 2.28 mmol/L | Standard Deviation 1.88 |
| IGlar | Change From Baseline in SMPG 9-point Profile: Prandial Plasma Glucose Increments (From Before Meal to 90 Min After Breakfast, Lunch and Dinner). The Mean Increment Over All Meals Will be Derived as the Mean of All Available Meal Increments | Change from baseline to week 26 | -0.09 mmol/L | Standard Deviation 1.96 |
Secondary
Change From Baseline in Systolic Blood Pressure
Change from baseline (week 0) in systolic blood pressure (BP) was evaluated after 26 weeks of randomised treatment.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change From Baseline in Systolic Blood Pressure | Systolic BP (mmHg) at baseline | 130.5 mmHg | Standard Deviation 14.3 |
| IDegLira | Change From Baseline in Systolic Blood Pressure | Systolic BP (mmHg) change from baseline to week 26 | -3.0 mmHg | Standard Deviation 12.7 |
| IGlar | Change From Baseline in Systolic Blood Pressure | Systolic BP (mmHg) at baseline | 128.9 mmHg | Standard Deviation 13.1 |
| IGlar | Change From Baseline in Systolic Blood Pressure | Systolic BP (mmHg) change from baseline to week 26 | 0.6 mmHg | Standard Deviation 12 |
Secondary
Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile
Change in 9-point SMPG profile was evaluated after 26 weeks of randomised treatment. SMPG measurements at baseline and week 26 are presented here at the following mentioned time points:1) Before breakfast, 2) 90 mins after the start of Breakfast, 3) Before lunch, 4) 90 mins after the start of lunch, 5) Before dinner, 6) 90 mins after the start of dinner, 7) At bedtime, 8) At 4 AM, 9) Before breakfast the following day.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline and week 26 for mentioned time points.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast - Baseline | 9.01 mmol/L | Standard Deviation 2.18 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after breakfast - Baseline | 11.79 mmol/L | Standard Deviation 3.09 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before lunch - Baseline | 8.93 mmol/L | Standard Deviation 2.8 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after lunch - Baseline | 11.24 mmol/L | Standard Deviation 3.26 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before dinner - Baseline | 9.33 mmol/L | Standard Deviation 2.7 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after dinner - Baseline | 11.40 mmol/L | Standard Deviation 3.04 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At bedtime - Baseline | 10.38 mmol/L | Standard Deviation 3.16 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At 4.00 AM - Baseline | 8.80 mmol/L | Standard Deviation 2.41 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast the following day - Baseline | 8.60 mmol/L | Standard Deviation 2.02 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast - Week 26 | 5.40 mmol/L | Standard Deviation 1.24 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after breakfast - Week 26 | 7.20 mmol/L | Standard Deviation 1.86 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before lunch - Week 26 | 5.83 mmol/L | Standard Deviation 1.36 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after lunch - Week 26 | 7.25 mmol/L | Standard Deviation 1.73 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before dinner - Week 26: | 6.43 mmol/L | Standard Deviation 1.61 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after dinner - Week 26 | 7.85 mmol/L | Standard Deviation 1.95 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At bedtime - Week 26 | 7.05 mmol/L | Standard Deviation 1.91 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At 4.00 AM - Week 26 | 5.58 mmol/L | Standard Deviation 1.17 |
| IDegLira | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast the following day - Week 26 | 5.23 mmol/L | Standard Deviation 1.09 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before dinner - Week 26: | 6.77 mmol/L | Standard Deviation 2.03 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast - Baseline | 9.00 mmol/L | Standard Deviation 1.91 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast - Week 26 | 5.39 mmol/L | Standard Deviation 1.21 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after breakfast - Baseline | 11.77 mmol/L | Standard Deviation 2.99 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast the following day - Week 26 | 5.36 mmol/L | Standard Deviation 1.38 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before lunch - Baseline | 9.20 mmol/L | Standard Deviation 2.95 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after breakfast - Week 26 | 8.35 mmol/L | Standard Deviation 2.4 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after lunch - Baseline | 11.22 mmol/L | Standard Deviation 3.06 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after dinner - Week 26 | 8.70 mmol/L | Standard Deviation 2.19 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before dinner - Baseline | 9.36 mmol/L | Standard Deviation 2.89 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before lunch - Week 26 | 6.35 mmol/L | Standard Deviation 1.88 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after dinner - Baseline | 11.40 mmol/L | Standard Deviation 2.99 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At 4.00 AM - Week 26 | 5.72 mmol/L | Standard Deviation 1.51 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At bedtime - Baseline | 10.71 mmol/L | Standard Deviation 3.13 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Ninety (90) minutes after lunch - Week 26 | 8.49 mmol/L | Standard Deviation 2.28 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At 4.00 AM - Baseline | 9.00 mmol/L | Standard Deviation 2.5 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | At bedtime - Week 26 | 7.79 mmol/L | Standard Deviation 2.2 |
| IGlar | Change From Baseline in the 9-point Self-measured Plasma Glucose (SMPG) Profile | Before breakfast the following day - Baseline | 8.81 mmol/L | Standard Deviation 1.92 |
Secondary
Change in Body Weight
The mean change from baseline (week 0) in body weight evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: Week 0, Week 26
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change in Body Weight | Body weight (kg) at baseline | 89.3 kg | Standard Deviation 17.6 |
| IDegLira | Change in Body Weight | Body weight (kg) change from baseline to week 26 | -0.0 kg | Standard Deviation 3.8 |
| IGlar | Change in Body Weight | Body weight (kg) at baseline | 87.2 kg | Standard Deviation 17.2 |
| IGlar | Change in Body Weight | Body weight (kg) change from baseline to week 26 | 2.0 kg | Standard Deviation 3.9 |
Comparison: This endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline weight as covariate. Data obtained after premature treatment discontinuation were included in the analysis. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.95% CI: [-2.64, -1.19]ANCOVA
Secondary
Change in Fasting Plasma Glucose (FPG)
Change from baseline (week 0) in FPG was evaluated after 26 weeks of randomised treatment.
Time frame: Week 0, Week 26
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at baseline (week 0) and week 26.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| IDegLira | Change in Fasting Plasma Glucose (FPG) | FPG (mmol/L) at baseline | 9.51 mmol/ L | Standard Deviation 2.69 |
| IDegLira | Change in Fasting Plasma Glucose (FPG) | FPG (mmol/L) change from baseline to week 26 | -3.72 mmol/ L | Standard Deviation 2.89 |
| IGlar | Change in Fasting Plasma Glucose (FPG) | FPG (mmol/L) at baseline | 9.57 mmol/ L | Standard Deviation 2.4 |
| IGlar | Change in Fasting Plasma Glucose (FPG) | FPG (mmol/L) change from baseline to week 26 | -3.50 mmol/ L | Standard Deviation 2.43 |
Secondary
Insulin Dose, Total Daily Dose (U)
Actual daily total insulin dose (Units) was evaluated after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| IDegLira | Insulin Dose, Total Daily Dose (U) | 36.2 Units (U) | Standard Deviation 13.4 |
| IGlar | Insulin Dose, Total Daily Dose (U) | 53.5 Units (U) | Standard Deviation 26.1 |
Comparison: The endpoint was analysed using an ANCOVA model with treatment, pre-trial OAD and region as factors and corresponding baseline HbA1c as covariate. Missing data were imputed using unconditional reference based multiple imputation including data obtained after premature treatment discontinuation.95% CI: [-19.6, -11.13]ANCOVA
Secondary
Number of Treatment-emergent Adverse Events
Treatment emergent adverse events (TEAEs) were recorded from week 0 to week 26. 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.
Time frame: Week 0-26
Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegLira | Number of Treatment-emergent Adverse Events | 450 Number of events |
| IGlar | Number of Treatment-emergent Adverse Events | 386 Number of events |
Secondary
Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks
American Diabetes Association (ADA) classification of hypoglycaemic episodes: 1)Severe: Requiring assistance of another person to actively administer carbohydrate/glucagon/take other corrective actions. PG levels may not be available during an event, but neurological recovery following return of PG to normal is considered sufficient evidence that event was induced by a low PG level. 2) Documented symptomatic: PG ≤3.9 mmol/L with symptoms. 3) Asymptomatic: PG ≤3.9 mmol/L without symptoms. 4) Probable symptomatic: No measurement with symptoms. 5) Pseudo: PG \>3.9 mmol/L with symptoms. 6) Unclassifiable.
Time frame: Week 0-26
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Documented symptomatic - ADA | 239 Number of episodes |
| IDegLira | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Probably symptomatic - ADA | 23 Number of episodes |
| IDegLira | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Severe - ADA | 1 Number of episodes |
| IDegLira | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Pseudo - ADA | 10 Number of episodes |
| IDegLira | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Asymptomatic - ADA | 850 Number of episodes |
| IDegLira | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Unclassifiable hypoglycaemia - ADA | 2 Number of episodes |
| IGlar | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Asymptomatic - ADA | 902 Number of episodes |
| IGlar | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Severe - ADA | 0 Number of episodes |
| IGlar | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Documented symptomatic - ADA | 419 Number of episodes |
| IGlar | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Unclassifiable hypoglycaemia - ADA | 0 Number of episodes |
| IGlar | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Probably symptomatic - ADA | 5 Number of episodes |
| IGlar | Number of Treatment-emergent Hypoglycaemic Episodes According to ADA Definition During 26 Weeks | Pseudo - ADA | 14 Number of episodes |
Secondary
Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks
Number of treatment-emergent nocturnal severe or BG confirmed symptomatic hypoglycaemic episodes (00:01-05:59 - inclusive) during 26 weeks of randomised treatment.
Time frame: Week 0-26
Population: The safety analysis set included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegLira | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks | 6 Number of episodes |
| IGlar | Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks | 13 Number of episodes |
Secondary
Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes
Severe or BG confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe (subjects who were not able to self-treat) and/or BG confirmed by a plasma glucose values \<3.1 mmol/L (56 mg/dL) with accompanied symptoms consistent with hypoglycaemia.
Time frame: Week 0-26
Population: The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or comparator. Subjects in the safety set contributed to the evaluation as treated.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| IDegLira | Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes | 38 Number of episodes |
| IGlar | Number of Treatment-emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes | 95 Number of episodes |
Comparison: This endpoint was analysed using a negative binomial regression model with a log link and the logarithm of the exposure time as offset. The model included treatment and pre-trial OAD as fixed factors. Missing data were imputed using multiple imputations (conditioning on expected event rate before premature treatment discontinuation or withdrawal from trial as if treated with IGlar).95% CI: [0.23, 0.75]Negative binomial regression model
Secondary
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5%
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% | Yes | 147 Participants |
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% | No | 50 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% | Yes | 100 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% | No | 102 Participants |
Secondary
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | Yes | 137 Particpants |
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | No | 60 Particpants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | Yes | 79 Particpants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | No | 123 Particpants |
Secondary
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5%without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | Yes | 77 Partcipants |
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | No | 120 Partcipants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | Yes | 24 Partcipants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | No | 178 Partcipants |
Secondary
Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets ≤ 6.5% without weight gain after 26 weeks of randomised treatment. The results are based on retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain | Yes | 84 Participants |
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain | No | 113 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain | No | 176 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c ≤ 6.5% Without Weight Gain | Yes | 26 Participants |
Secondary
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment
The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | Yes | 156 Participants |
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | No | 41 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | Yes | 114 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment | No | 88 Participants |
Secondary
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the last 12 weeks of treatment and without weight gain. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | Yes | 83 Participants |
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | No | 114 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | Yes | 34 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During the Last 12 Weeks of Treatment and Without Weight Gain | No | 168 Participants |
Secondary
Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain
The proportion of subjects achieving pre-defined HbA1c targets \<7.0% without weight gain after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain | Yes | 91 Participants |
| IDegLira | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain | No | 106 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain | Yes | 38 Participants |
| IGlar | Responder After 26 Weeks (Yes/No) for: HbA1c < 7.0% Without Weight Gain | No | 164 Participants |
Secondary
Responder (Yes/No) for HbA1c Below 7.0%
The proportion of subjects achieving pre-defined HbA1c targets \<7.0% after 26 weeks of randomised treatment. The results presented included retrieved data at week 26 for subjects who prematurely discontinued the trial product.
Time frame: After 26 weeks
Population: The FAS included all randomised subjects. The statistical evaluation of the FAS followed the intent-to-treat (ITT) principle and subjects contributed to the evaluation as randomised. Number analysed = Number of subjects contributed to the analysis at week 26.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| IDegLira | Responder (Yes/No) for HbA1c Below 7.0% | Yes | 167 Participants |
| IDegLira | Responder (Yes/No) for HbA1c Below 7.0% | No | 30 Participants |
| IGlar | Responder (Yes/No) for HbA1c Below 7.0% | Yes | 144 Participants |
| IGlar | Responder (Yes/No) for HbA1c Below 7.0% | No | 58 Participants |