A Phase 3 interventional study of insulin degludec/liraglutide and insulin glargine in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Completed at 143 sites in 16 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-27.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
This trial is conducted in Africa, Asia, Europe, North America and South America. The purpose is to compare long-term glycaemic control of insulin degludec/liraglutide (IDegLira) versus insulin glargine (IGlar) in insulin naïve subjects with type 2 diabetes mellitus inadequately controlled with oral anti diabetics.
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Exclusion Criteria:
Drug: insulin degludec/liraglutide
Drug: insulin glargine
Drug pages: Insulin degludec · Liraglutide
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
Injected subcutaneously (under the skin) once daily for 104 weeks. Dose individually adjusted.
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.
Time frame: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2
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.
Time frame: Weeks 0-104 + 7 days follow-up-1 + 30 days follow-up-2
Change in HbA1c
Change in HbA1c from baseline (week 0) to week 26 is presented.
Time frame: Week 0, week 26
Change in Body Weight
Change in body weight from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Insulin Dose
Insulin dose after 26 and 104 weeks of treatment is presented.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 26, week 104
Change in FPG
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Weeks 0-26
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.
Time frame: Weeks 0-104
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.
Time frame: Weeks 0-26
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.
Time frame: Weeks 0-104
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.
Time frame: Weeks 0-26
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.
Time frame: Weeks 0-104
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.
Time frame: Weeks 0-26
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.
Time frame: Week 0 to week 104
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.
Time frame: Baseline (within 12 weeks prior to week 0), week 104
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.
Time frame: Baseline (within 2 weeks prior to week 0), week 104
Change in Urine Albumin/Creatinine Ratio
Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.
Time frame: Week 0, week 104
Change in Pulse Rate
Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
Change in Biochemistry Parameter- Albumin
Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Haemoglobin
Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Haematocrit
Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Erythrocytes
Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Thrombocytes and Leukocytes
Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Eosinophils
Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Neutrophils
Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Basophils
Change in basophils from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Monocytes
Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
Change in Haematological Parameter- Lymphocytes
Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
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.
Time frame: Week 0, week 26, week 104
The trial was conducted at 130 sites in Argentina (4),Czech Republic (4), Hungary (5), India (11), Israel (8), Italy (7), Mexico (4), Norway (7), Poland (3), Russian Federation (8), Slovakia (5), South Africa (10), Turkey (8), United Kingdom (9) and United States (37).
| Milestone | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Started | 506 | 506 |
| Exposed | 506 | 504 |
| Completed | 484 | 481 |
| Not completed | 22 | 25 |
| Withdrew: Adverse event | 2 | 6 |
| Withdrew: Lost to follow-up | 7 | 4 |
| Withdrew: Withdrawal by subject | 10 | 15 |
| Withdrew: Other | 3 | 0 |
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.
| Weeks | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Baseline HbA1c <8.5% + Non-SU users | NA (104.0 to NA) | 104.3 (38.1 to NA) |
| Baseline HbA1c <8.5% + SU users | 106.7 (89.9 to NA) | 90.3 (26.4 to 105.1) |
| Baseline HbA1c >=8.5% + Non-SU users | NA (39.7 to NA) | 64.6 (26.1 to 105.1) |
| Baseline HbA1c >=8.5% + SU users | 104.0 (26.4 to NA) | 26.6 (26.1 to 91.1) |
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.
| Weeks | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Baseline HbA1c <8.5% + Non-SU users | NA (52.1 to NA) | 64.1 (26.1 to 104.3) |
| Baseline HbA1c <8.5% + SU users | 90.1 (27.0 to NA) | 26.6 (26.1 to 89.9) |
| Baseline HbA1c >=8.5% + Non-SU users | 64.1 (26.1 to NA) | 26.6 (26.1 to 90.1) |
| Baseline HbA1c >=8.5% + SU users | 52.1 (26.1 to 104.1) | 26.1 (26.1 to 38.1) |
Change in HbA1c from baseline (week 0) to week 26 is presented.
| Percentage of HbA1c | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Change in HbA1c | -1.99 ± 1.14 | -1.69 ± 1.10 |
Change in body weight from baseline (week 0) to week 26 and week 104 is presented.
| Kilogram (kg) | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.5 ± 3.3 | 2.2 ± 3.6 |
| Week 104 | 1.2 ± 4.9 | 3.0 ± 4.9 |
Insulin dose after 26 and 104 weeks of treatment is presented.
| Units | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 34.6 ± 13.4 | 48.6 ± 28.2 |
| Week 104 | 36.1 ± 12.9 | 50.6 ± 31.5 |
Percentage of participants who achieved (yes/no) HbA1c \<7.0% at week 26 and week 104 is presented.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 78.7 | 55.7 |
| Week 26: No | 21.3 | 44.3 |
| Week 104: Yes | 55.5 | 28.5 |
| Week 104: No | 44.5 | 71.5 |
Percentage of participants who achieved (yes/no) HbA1c \<7.0% without weight gain at week 26 and week 104 is presented.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 38.5 | 15.4 |
| Week 26: No | 61.5 | 84.6 |
| Week 104: Yes | 20.9 | 6.3 |
| Week 104: No | 79.1 | 93.7 |
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.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 71.3 | 44.9 |
| Week 26: No | 28.7 | 55.1 |
| Week 104: Yes | 51.8 | 25.5 |
| Week 104: No | 48.2 | 74.5 |
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.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 35.2 | 13.6 |
| Week 26: No | 64.8 | 86.4 |
| Week 104: Yes | 20.0 | 6.1 |
| Week 104: No | 80.0 | 93.9 |
Percentage of participants who achieved (yes/no) HbA1c ≤6.5% at week 26 and week 104 is presented.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 63.6 | 35.4 |
| Week 26: No | 36.4 | 64.6 |
| Week 104: Yes | 43.3 | 21.7 |
| Week 104: No | 56.7 | 78.3 |
Percentage of participants who achieved (yes/no) HbA1c ≤6.5% without weight gain at week 26 and week 104 is presented.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 33.2 | 9.9 |
| Week 26: No | 66.8 | 90.1 |
| Week 104: Yes | 17.6 | 5.7 |
| Week 104: No | 82.4 | 94.3 |
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.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 57.9 | 27.9 |
| Week 26: No | 42.1 | 72.1 |
| Week 104: Yes | 40.1 | 19.2 |
| Week 104: No | 59.9 | 80.8 |
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.
| Percentage of participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Yes | 30.2 | 8.7 |
| Week 26: No | 69.8 | 91.3 |
| Week 104: Yes | 16.6 | 5.5 |
| Week 104: No | 83.4 | 94.5 |
Change in fasting plasma glucose (FPG) from baseline (week 0) to week 26 and week 104 is presented.
| mmol/L | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -3.97 ± 3.06 | -3.79 ± 3.18 |
| Week 104 | -3.93 ± 2.96 | -3.73 ± 2.75 |
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.
| mmol/L | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Before breakfast | 5.59 ± 1.57 | 5.58 ± 1.58 |
| Week 26: 90 minutes after breakfast | 8.34 ± 2.62 | 8.76 ± 2.68 |
| Week 26: Before lunch | 6.03 ± 2.00 | 6.43 ± 2.24 |
| Week 26: 90 minutes after lunch | 8.02 ± 2.32 | 8.79 ± 2.64 |
| Week 26: Before dinner | 6.67 ± 2.26 | 6.91 ± 2.35 |
| Week 26: 90 minutes after dinner | 8.31 ± 2.47 | 9.10 ± 2.70 |
| Week 26: Bedtime | 7.48 ± 2.42 | 8.13 ± 2.68 |
| Week 26: At 4:00 a.m. | 5.72 ± 1.55 | 5.91 ± 1.99 |
| Week 26: Before breakfast the following day | 5.53 ± 1.37 | 5.56 ± 1.56 |
| Week 104: Before breakfast | 5.58 ± 1.38 | 5.57 ± 1.27 |
| Week 104: 90 minutes after breakfast | 7.99 ± 2.50 | 8.64 ± 2.59 |
| Week 104: Before lunch | 6.06 ± 1.91 | 6.37 ± 2.02 |
| Week 104: 90 minutes after lunch | 7.80 ± 2.16 | 8.87 ± 2.45 |
| Week 104: Before dinner | 6.58 ± 1.97 | 7.02 ± 2.45 |
| Week 104: 90 minutes after dinner | 8.20 ± 2.20 | 9.10 ± 2.61 |
| Week 104: Bedtime | 7.47 ± 2.17 | 7.90 ± 2.41 |
| Week 104: At 4:00 a.m. | 5.67 ± 1.35 | 5.96 ± 1.73 |
| Week 104: Before breakfast the following day | 5.44 ± 1.23 | 5.47 ± 1.35 |
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.
| mmol/L | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -3.34 ± 2.46 | -3.32 ± 2.62 |
| Week 104 | -3.27 ± 2.36 | -2.76 ± 2.41 |
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.
| mmol/L | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -0.28 ± 2.13 | 0.20 ± 2.17 |
| Week 104 | -0.47 ± 1.99 | 0.12 ± 2.17 |
Change in blood pressure (systolic and diastolic) from baseline (week 0) to week 26 and week 104 is presented.
| Millimeters of mercury (mmHg) | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Systolic blood pressure | -1.2 ± 14.0 | 0.5 ± 13.1 |
| Week 26: Diastolic blood pressure | 0.1 ± 8.8 | -0.3 ± 8.4 |
| Week 104: Systolic blood pressure | 0.5 ± 14.3 | 0.9 ± 13.6 |
| Week 104: Diastolic blood pressure | -0.1 ± 8.8 | -0.2 ± 8.6 |
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.
| Ratio of C-peptide | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.63 ± 60.79 | 0.57 ± 62.44 |
| Week 104 | 0.58 ± 64.21 | 0.54 ± 70.45 |
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.
| Ratio of insulin | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.67 ± 90.68 | 0.68 ± 89.19 |
| Week 104 | 0.60 ± 91.84 | 0.62 ± 92.55 |
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.
| Ratio of total cholesterol | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.99 ± 17.38 | 0.99 ± 17.68 |
| Week 104 | 0.97 ± 19.11 | 0.97 ± 20.40 |
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.
| Ratio of LDL-cholesterol | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 1.05 ± 35.97 | 1.02 ± 30.10 |
| Week 104 | 0.96 ± 38.83 | 0.98 ± 34.40 |
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.
| Ratio of HDL-cholesterol | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 1.03 ± 16.61 | 1.02 ± 15.57 |
| Week 104 | 1.02 ± 16.93 | 1.03 ± 17.36 |
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.
| Ratio of VLDL-cholesterol | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.85 ± 40.78 | 0.85 ± 42.01 |
| Week 104 | 0.90 ± 40.90 | 0.88 ± 35.98 |
Change in fasting triglycerides (measured as mmol/L) from baseline (week 0) to week 26 and week 104 is presented as ratio to baseline.
| Ratio of triglycerides | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.84 ± 43.82 | 0.85 ± 45.75 |
| Week 104 | 0.89 ± 42.20 | 0.89 ± 40.08 |
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.
| Ratio of free fatty acids | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.68 ± 59.69 | 0.75 ± 60.25 |
| Week 104 | 0.70 ± 57.71 | 0.78 ± 59.48 |
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.
| Episodes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | 143 | 261 |
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.
| Episodes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of Treatment-emergent Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | 319 | 642 |
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.
| Episodes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of Treatment Emergent Hypoglycaemic Episodes During 26 Weeks of Treatment | 3190 | 3806 |
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.
| Episodes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of Treatment Emergent Hypoglycaemic Episodes During 104 Weeks of Treatment | 8934 | 10658 |
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.
| Episodes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 26 Weeks of Treatment | 27 | 60 |
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.
| Episodes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of Treatment-emergent Nocturnal Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During 104 Weeks of Treatment | 61 | 164 |
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.
| Adverse events | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of TEAEs During 26 Weeks of Treatment | 718 | 624 |
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.
| Adverse events | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Number of TEAEs During 104 Weeks of Treatment | 1788 | 1368 |
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.
| Participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Left eye: Normal (baseline) | 345 | 341 |
| Left eye: Abnormal NCS (baseline) | 151 | 155 |
| Left eye: Abnormal CS (baseline) | 10 | 8 |
| Left eye: Normal (week 104) | 204 | 129 |
| Left eye: Abnormal NCS (week 104) | 97 | 50 |
| Left eye: Abnormal CS (week 104) | 17 | 6 |
| Right eye: Normal (baseline) | 344 | 355 |
| Right eye: Abnormal NCS (baseline) | 151 | 143 |
| Right eye: Abnormal CS (baseline) | 11 | 6 |
| Right eye: Normal (week 104) | 200 | 132 |
| Right eye: Abnormal NCS (week 104) | 99 | 48 |
| Right eye: Abnormal CS (week 104) | 19 | 5 |
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.
| Participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Normal (Baseline) | 335 | 335 |
| Abnormal NCS (Baseline) | 162 | 165 |
| Abnormal CS (Baseline) | 9 | 4 |
| Normal (week 104) | 227 | 122 |
| Abnormal NCS (week 104) | 97 | 65 |
| Abnormal CS (week 104) | 7 | 2 |
Change in urine albumin/creatinine ratio from baseline (week 0) to week 104 is presented.
| Milligrams per millimole (mg/mmol) | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Change in Urine Albumin/Creatinine Ratio | -1.09 ± 7.43 | -0.74 ± 15.58 |
Change in pulse rate from baseline (week 0) to week 26 and week 104 is presented.
| Beats per minute | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 2.0 ± 8.8 | -0.4 ± 8.7 |
| Week 104 | 1.7 ± 9.3 | -0.5 ± 9.7 |
Change in biochemistry parameter- creatinine, total bilirubin from baseline (week 0) to week 26 and week 104 is presented.
| Micromoles per liter (umol/L) | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: creatinine | -0.50 ± 10.08 | 0.25 ± 8.78 |
| Week 104: creatinine | 0.75 ± 10.85 | 2.20 ± 11.86 |
| Week 26: total bilirubin | -0.30 ± 3.35 | -0.32 ± 2.80 |
| Week 104: total bilirubin | -0.33 ± 3.42 | -0.59 ± 3.01 |
Change in biochemistry parameter- albumin from baseline (week 0) to week 26 and week 104 is presented.
| Grams per deciliter (g/dL) | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -0.03 ± 0.24 | -0.03 ± 0.21 |
| Week 104 | 0.01 ± 0.24 | 0.03 ± 0.27 |
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.
| Units per liter (U/L) | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: ALP | -4.16 ± 14.16 | -4.33 ± 12.84 |
| Week 104: ALP | -1.35 ± 15.71 | -1.34 ± 14.22 |
| Week 26: ALT | -5.45 ± 18.50 | -3.33 ± 13.24 |
| Week 104: ALT | -5.39 ± 14.16 | -3.45 ± 14.46 |
| Week 26: AST | -1.62 ± 9.78 | -0.39 ± 9.51 |
| Week 104: AST | -1.84 ± 9.86 | -0.67 ± 10.78 |
| Week 26: lipase | 9.26 ± 42.92 | -7.97 ± 34.28 |
| Week 104: lipase | 5.41 ± 48.35 | -13.33 ± 42.27 |
| Week 26: amylase | 9.72 ± 23.28 | 2.79 ± 20.92 |
| Week 104: amylase | 7.23 ± 25.42 | -0.13 ± 25.94 |
Change in sodium, potassium and calcium from baseline (week 0) to week 26 and week 104 is presented.
| mmol/L | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: sodium | 0.89 ± 2.74 | 1.03 ± 2.61 |
| Week 104: sodium | 1.22 ± 2.54 | 1.47 ± 2.39 |
| Week 26: potassium | -0.05 ± 0.40 | -0.08 ± 0.42 |
| Week 104: potassium | -0.06 ± 0.42 | -0.07 ± 0.43 |
| Week 26: calcium | -0.01 ± 0.11 | -0.00 ± 0.11 |
| Week 104: calcium | -0.07 ± 0.10 | -0.06 ± 0.11 |
Change in haemoglobin from baseline (week 0) to week 26 and week 104 is presented.
| g/dL | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.08 ± 0.72 | 0.08 ± 0.74 |
| Week 104 | -0.00 ± 0.89 | -0.03 ± 0.92 |
Change in haematocrit from baseline (week 0) to week 26 and week 104 is presented.
| Percentage of red blood cells | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -0.33 ± 2.45 | -0.36 ± 2.43 |
| Week 104 | -0.71 ± 2.83 | -0.95 ± 3.02 |
Change in erythrocytes from baseline (week 0) to week 26 and week 104 is presented.
| 10^12 cells/L | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -0.02 ± 0.28 | -0.03 ± 0.27 |
| Week 104 | -0.12 ± 0.30 | -0.11 ± 0.32 |
Change in thrombocytes and leukocytes from baseline (week 0) to week 26 and week 104 is presented.
| 10^9 cells/L | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Thrombocytes | 8.77 ± 35.82 | 7.05 ± 41.71 |
| Week 104: Thrombocytes | 16.87 ± 39.27 | 18.73 ± 53.76 |
| Week 26: Leukocytes | 0.49 ± 1.45 | 0.39 ± 1.43 |
| Week 104: Leukocytes | 0.07 ± 1.50 | 0.32 ± 1.55 |
Change in eosinophils from baseline (week 0) to week 26 and week 104 is presented.
| Percentage of eosinophils | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.10 ± 1.88 | 0.06 ± 2.09 |
| Week 104 | 0.32 ± 2.08 | 0.43 ± 1.56 |
Change in neutrophils from baseline (week 0) to week 26 and week 104 is presented.
| Percentage of neutrophils | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 1.86 ± 7.20 | 0.78 ± 7.68 |
| Week 104 | 1.25 ± 7.94 | 1.21 ± 8.02 |
Change in basophils from baseline (week 0) to week 26 and week 104 is presented.
| Percentage of basophils | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 0.00 ± 0.28 | -0.00 ± 0.29 |
| Week 104 | 0.20 ± 0.38 | 0.16 ± 0.35 |
Change in monocytes from baseline (week 0) to week 26 and week 104 is presented.
| Percentage of monocytes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -0.10 ± 2.04 | 0.01 ± 1.91 |
| Week 104 | 0.49 ± 2.02 | 0.59 ± 1.88 |
Change in lymphocytes from baseline (week 0) to week 26 and week 104 is presented.
| Percentage of lymphocytes | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | -1.87 ± 6.29 | -0.84 ± 6.73 |
| Week 104 | -2.25 ± 6.76 | -2.38 ± 7.29 |
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.
| Participants | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 0: Low | 0 | 0 |
| Week 0: Normal | 481 | 472 |
| Week 0: High | 25 | 32 |
| Week 26: Low | 0 | 0 |
| Week 26: Normal | 437 | 431 |
| Week 26: High | 40 | 30 |
| Week 104: Low | 0 | 0 |
| Week 104: Normal | 301 | 169 |
| Week 104: High | 31 | 17 |
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.
| Score on a scale | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26: Physical functioning | 1.2 ± 6.8 | 1.1 ± 7.0 |
| Week 104: Physical functioning | 0.7 ± 7.5 | 0.6 ± 7.9 |
| Week 26: Role-physical | 1.4 ± 7.7 | 0.5 ± 7.4 |
| Week 104: Role-physical | 1.4 ± 8.7 | 0.7 ± 7.5 |
| Week 26: Bodily pain | 1.5 ± 9.7 | 0.4 ± 10.0 |
| Week 104: Bodily pain | 1.6 ± 11.2 | 0.1 ± 8.5 |
| Week 26: General health | 2.5 ± 8.2 | 2.1 ± 7.6 |
| Week 104: General health | 2.3 ± 8.7 | 2.1 ± 8.3 |
| Week 26: Vitality | 1.4 ± 8.1 | 1.4 ± 8.0 |
| Week 104: Vitality | 1.5 ± 8.4 | 1.5 ± 8.0 |
| Week 26: Social functioning | 1.8 ± 8.1 | 0.9 ± 8.8 |
| Week 104: Social functioning | 0.9 ± 8.9 | 1.1 ± 7.6 |
| Week 26: Role-emotional | 0.6 ± 8.9 | 0.7 ± 8.8 |
| Week 104: Role-emotional | 1.6 ± 10.1 | 1.2 ± 8.2 |
| Week 26: Mental health | 1.7 ± 8.7 | 1.3 ± 8.4 |
| Week 104: Mental health | 2.5 ± 9.4 | 0.3 ± 8.9 |
| Week 26: PCS | 1.6 ± 6.3 | 0.9 ± 6.3 |
| Week 104: PCS | 1.0 ± 7.2 | 0.8 ± 6.0 |
| Week 26: MCS | 1.3 ± 8.2 | 1.2 ± 8.0 |
| Week 104: MCS | 2.0 ± 9.0 | 1.0 ± 7.8 |
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.
| Score on a scale | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Week 26 | 9.6 ± 12.4 | 7.3 ± 13.1 |
| Week 104 | 11.4 ± 13.7 | 9.5 ± 12.8 |
Collected over Weeks 0-104 (treatment period) + 7 days follow-up-1 + 30 days follow-up-2. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Insulin Degludec/Liraglutide | 2/506 (0.4%) | 60/506 (11.9%) | 206/506 (40.7%) |
| Insulin Glargine | 5/504 (1%) | 43/504 (8.5%) | 156/504 (31%) |
| Event | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| Angina unstableCardiac disorders | 4/506 | 0/504 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 4/506 | 3/504 |
| CholelithiasisHepatobiliary disorders | 2/506 | 3/504 |
| Acute myocardial infarctionCardiac disorders | 3/506 | 2/504 |
| Cholecystitis acuteHepatobiliary disorders | 3/506 | 1/504 |
| FallInjury, poisoning and procedural complications | 3/506 | 0/504 |
| Lower respiratory tract infectionInfections and infestations | 3/506 | 0/504 |
| Peripheral arterial occlusive diseaseVascular disorders | 3/506 | 0/504 |
| Atrial fibrillationCardiac disorders | 0/506 | 2/504 |
| Basal cell carcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/506 | 2/504 |
| Event | Insulin Degludec/Liraglutide | Insulin Glargine |
|---|---|---|
| HeadacheNervous system disorders | 58/506 | 45/504 |
| NasopharyngitisInfections and infestations | 57/506 | 44/504 |
| DiarrhoeaGastrointestinal disorders | 39/506 | 12/504 |
| Upper respiratory tract infectionInfections and infestations | 28/506 | 36/504 |
| InfluenzaInfections and infestations | 36/506 | 28/504 |
| NauseaGastrointestinal disorders | 31/506 | 8/504 |
| ArthralgiaMusculoskeletal and connective tissue disorders | 24/506 | 29/504 |
| Back painMusculoskeletal and connective tissue disorders | 25/506 | 27/504 |
Full analysis set (FAS) included all randomised participants.
| Age, Continuous(Years) | Insulin Degludec/Liraglutide | Insulin Glargine | Total |
|---|---|---|---|
| Mean | 56.8 ± 10.0 | 56.4 ± 10.1 | 56.6 ± 10.0 |
| Sex: Female, Male(Participants) | Insulin Degludec/Liraglutide | Insulin Glargine | Total |
|---|---|---|---|
| Female | 226 | 231 | 457 |
| Male | 280 | 275 | 555 |
| Ethnicity (NIH/OMB)(Participants) | Insulin Degludec/Liraglutide | Insulin Glargine | Total |
|---|---|---|---|
| Hispanic or Latino | 115 | 126 | 241 |
| Not Hispanic or Latino | 391 | 380 | 771 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race/Ethnicity, Customized(Participants) | Insulin Degludec/Liraglutide | Insulin Glargine | Total |
|---|---|---|---|
| White | 424 | 414 | 838 |
| Black or African American | 25 | 28 | 53 |
| Asian | 54 | 61 | 115 |
| Other | 3 | 3 | 6 |
Showing the first 100 of 143 sites across 16 countries.
Documents are hosted by the registry — open the source record to download them.
Ran from Jan 2016 to primary completion in Oct 2018, 32 months.
Results were first posted in Nov 2019, 1 year 1 month after primary completion.
Of 353 industry-sponsored phase 3 interventional studies under Diabetes Mellitus, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 25. This study's 32 months is above that.
Counting every sponsor, half of 457 studies reached it within 19 months; a quarter within 14 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Insulin degludec · Liraglutide