Trial Outcomes & Findings for A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes (NCT NCT01392573)
NCT ID: NCT01392573
Last Updated: 2019-01-03
Results Overview
Observed mean change from baseline in HbA1c after 26 Weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
413 participants
Primary outcome timeframe
Week 0, week 26
Results posted on
2019-01-03
Participant Flow
The trial was conducted at 75 sites in 7 countries: Bulgaria (6), Switzerland (2), Denmark (3), Hungary (3), India (6), Slovenia (3), and the United States (52).
Participant milestones
| Measure |
IDegLira
Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
|
IDeg
Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
|
|---|---|---|
|
Overall Study
STARTED
|
207
|
206
|
|
Overall Study
Exposed
|
207
|
206
|
|
Overall Study
COMPLETED
|
175
|
171
|
|
Overall Study
NOT COMPLETED
|
32
|
35
|
Reasons for withdrawal
| Measure |
IDegLira
Insulin degludec/liraglutide (IDegLira) was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast self-monitored plasma glucose (SMPG) values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
|
IDeg
Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
3
|
|
Overall Study
Lack of Efficacy
|
1
|
2
|
|
Overall Study
Protocol Violation
|
0
|
2
|
|
Overall Study
Withdrawal Criteria
|
13
|
15
|
|
Overall Study
Site closure
|
8
|
7
|
|
Overall Study
Unclassified
|
9
|
6
|
Baseline Characteristics
A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide and Insulin Degludec in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDegLira
n=199 Participants
IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
|
IDeg
n=199 Participants
Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
|
Total
n=398 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
56.8 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
57.2 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
87 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
180 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
112 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
218 Participants
n=5 Participants
|
|
HbA1c (glycosylated haemoglobin)
|
8.7 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.7 • n=5 Participants
|
8.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.7 • n=7 Participants
|
8.8 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.7 • n=5 Participants
|
|
Body Weight
|
95.4 kg
STANDARD_DEVIATION 19.4 • n=5 Participants
|
93.5 kg
STANDARD_DEVIATION 20.0 • n=7 Participants
|
94.5 kg
STANDARD_DEVIATION 19.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, week 26Population: Full analysis set. Missing data was imputed using last observation carried forward (LOCF).
Observed mean change from baseline in HbA1c after 26 Weeks of treatment.
Outcome measures
| Measure |
IDegLira
n=199 Participants
IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
|
IDeg
n=199 Participants
Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
|
|---|---|---|
|
Change From Baseline in HbA1c (Glycosylated Haemoglobin)
|
-1.90 percentage of glycosylated haemoglobin
Standard Deviation 1.09
|
-0.89 percentage of glycosylated haemoglobin
Standard Deviation 1.18
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Full analysis set. Missing data was imputed using LOCF.
Observed mean change from baseline in body weight after 26 Weeks of treatment.
Outcome measures
| Measure |
IDegLira
n=199 Participants
IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
|
IDeg
n=199 Participants
Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
|
|---|---|---|
|
Change in Body Weight
|
-2.7 kg
Standard Deviation 3.7
|
0.0 kg
Standard Deviation 3.4
|
Adverse Events
IDegLira
Serious events: 7 serious events
Other events: 45 other events
Deaths: 0 deaths
IDeg
Serious events: 11 serious events
Other events: 29 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegLira
n=199 participants at risk
IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
|
IDeg
n=199 participants at risk
Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Cardiac disorders
Atrial fibrillation
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Cardiac disorders
Ventricular fibrillation
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Cardiac disorders
Ventricular tachycardia
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Infections and infestations
Pneumonia
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Infections and infestations
Vestibular neuronitis
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Acetabulum fracture
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Convulsion
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Mononeuropathy
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Nervous system disorders
VIIth nerve paralysis
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Vertigo CNS origin
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Psychiatric disorders
Major depression
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Renal and urinary disorders
Renal failure acute
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.00%
0/199 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
0.50%
1/199 • Number of events 1 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
Other adverse events
| Measure |
IDegLira
n=199 participants at risk
IDegLira was injected subcutaneously (under the skin) once daily for 26 weeks in combination with metformin treatment. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDegLira was initiated at 16 dose steps containing 16 units insulin degludec and 0.6 mg liraglutide. Dose adjustment of IDegLira was to be performed twice weekly based on the mean of three pre-breakfast SMPG values measured on the day of titration and the two days prior to titration aiming at a fasting glycaemic target of 4.0-5.0 mmol/L.
|
IDeg
n=199 participants at risk
Insulin degludec (IDeg) was injected subcutaneously (under the skin) once daily for 26 weeks. Metformin dose was maintained at the stable, pre-randomisation dose and frequency level. Treatment with IDeg was initiated with 16 units. Dose adjustment of IDeg was to be performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
6.5%
13/199 • Number of events 21 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
3.5%
7/199 • Number of events 8 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Gastrointestinal disorders
Nausea
|
6.5%
13/199 • Number of events 20 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
3.5%
7/199 • Number of events 7 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
5/199 • Number of events 5 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
6.0%
12/199 • Number of events 14 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Investigations
Lipase increased
|
6.0%
12/199 • Number of events 12 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
3.5%
7/199 • Number of events 7 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
|
Nervous system disorders
Headache
|
6.0%
12/199 • Number of events 23 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
2.0%
4/199 • Number of events 6 • Adverse events were captured from the time of consent untill 26 weeks of treatment, and were followed-up for 7 days after the final visit (upto overall 27 weeks).
Safety analysis set included all subjects receiving at least one dose of the investigational product or comparator except 15 subjects (8 in IDegLira arm and 7 in IDeg arm) that were excluded due to site closure. Subjects in the safety analysis set contributed to the evaluation "as treated".
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee At the end of the trial, one or more scientific publications may be prepared collaboratively by the investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER