Trial Outcomes & Findings for The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy (NCT NCT01618162)
NCT ID: NCT01618162
Last Updated: 2017-10-27
Results Overview
Change in HbA1c from baseline to 26 weeks.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
435 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2017-10-27
Participant Flow
The trial was conducted at 77 sites in 7 countries: Bulgaria (7), Canada (9), Germany (6), India (6), Israel (7), Turkey (3), United States (39).
The trial included a 2 week screening period to assess subject eligibility.
Participant milestones
| Measure |
IDegLira
In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Overall Study
STARTED
|
289
|
146
|
|
Overall Study
Exposed
|
288
|
146
|
|
Overall Study
COMPLETED
|
251
|
111
|
|
Overall Study
NOT COMPLETED
|
38
|
35
|
Reasons for withdrawal
| Measure |
IDegLira
In this arm, subjects suboptimally controlled on sulfonyl urea (SU) +/- metformin, were given subcutenaous (s.c.) injection of insulin degludec/liraglutide (IDegLira). SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Overall Study
Protocol Violation
|
13
|
10
|
|
Overall Study
Adverse Event
|
9
|
2
|
|
Overall Study
Withdrawal Criteria
|
2
|
10
|
|
Overall Study
Unclassified
|
14
|
13
|
Baseline Characteristics
The Efficacy of Insulin Degludec/Liraglutide as add-on Therapy in Controlling Glycaemia in Adults With Type 2 Diabetes Inadequately Controlled on Sulphonylurea With or Without Metformin Therapy
Baseline characteristics by cohort
| Measure |
IDegLira
n=289 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Total
n=435 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
59.4 years
STANDARD_DEVIATION 10.8 • n=7 Participants
|
59.8 years
STANDARD_DEVIATION 10.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
208 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
154 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
227 Participants
n=5 Participants
|
|
Glycosylated haemoglobin
|
7.9 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=5 Participants
|
7.9 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=7 Participants
|
7.9 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.6 • n=5 Participants
|
|
Fasting plasma glucose
|
9.1 mmol/L
STANDARD_DEVIATION 2.2 • n=5 Participants
|
9.1 mmol/L
STANDARD_DEVIATION 2.1 • n=7 Participants
|
9.1 mmol/L
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Body weight
|
87.2 kilograms
STANDARD_DEVIATION 18.6 • n=5 Participants
|
89.3 kilograms
STANDARD_DEVIATION 17.5 • n=7 Participants
|
87.9 kilograms
STANDARD_DEVIATION 18.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: Full analysis set.
Change in HbA1c from baseline to 26 weeks.
Outcome measures
| Measure |
IDegLira
n=289 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.45 percentage of glycosylated haemoglobin
Standard Deviation 0.84
|
-0.46 percentage of glycosylated haemoglobin
Standard Deviation 0.83
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set.
Percentage of subjects having HbA1c below 7% at week 26.
Outcome measures
| Measure |
IDegLira
n=289 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Responders Achieving Pre-defined Target: HbA1c Below 7.0% (53 mmol/Mol)
|
79.2 percentage of subjects
|
28.8 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 26Population: Full analysis set.
Percentage of subjects having HbA1c below 6.5% at week 26
Outcome measures
| Measure |
IDegLira
n=289 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Responders Achieving Pre-defined Target: HbA1c Below or Equal to 6.5% (48 mmol/Mol)
|
64 percentage of subjects
|
12.3 percentage of subjects
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Full analysis set. Number of subjects analyzed=subjects with data available for FPG.
Change from baseline in FPG at week 26.
Outcome measures
| Measure |
IDegLira
n=286 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=144 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Change From Baseline in Fasting Plasma Glucose (FPG)
|
-2.6 mmol/L
Standard Deviation 2.61
|
-0.31 mmol/L
Standard Deviation 2.43
|
SECONDARY outcome
Timeframe: Week 0, week 26Population: Full analysis set.
Change from baseline in body weight at week 26.
Outcome measures
| Measure |
IDegLira
n=289 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Change From Baseline in Body Weight
|
0.5 kilogram
Standard Deviation 3.1
|
-1 kilogram
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: Safety analysis set included all subjects receiving at least one dose of the trial product.
An event was treatment emergent if the onset of the episode occurs after the first administration of trial product and no later than 7 days after last trial product administration. Confirmed hypoglycaemic episodes were defined as hypoglycaemic episodes that were either severe or minor. Minor hypoglycaemic episodes were defined as: 1. An episode with symptoms consistent with hypoglycaemia and confirmed by blood glucose value \<2.8 mmol/L (50 mg/dL) or plasma glucose \<3.1 mmol/L (56 mg/dL) and which was handled by the subject himself/herself. 2. Any asymptomatic PG value \<3.1 mmol/L (56 mg/dL) or blood glucose value \<2.8 mmol/L (50 mg/dL). Severe hypoglycemia was defined as an episode requiring assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions. Reported values are hypoglycemia event rate per 100 patient-years of exposure (PYE).
Outcome measures
| Measure |
IDegLira
n=288 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Number of Treatment Emergent (Confirmed) Hypoglycaemic Episodes
|
351.7 event rate per 100 PYE
|
135.2 event rate per 100 PYE
|
SECONDARY outcome
Timeframe: After 26 weeks of treatmentPopulation: Safety analysis set.
An AE was any unfavourable and unintended sign (including an abnormal laboratory finding), symptom or disease temporally associated with the use of a product, whether or not considered related to the product. Reported values are hypoglycemia event rate per 100 PYE.
Outcome measures
| Measure |
IDegLira
n=288 Participants
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 Participants
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Number of Adverse Events (AEs)
|
401.4 event rate per 100 PYE
|
367 event rate per 100 PYE
|
Adverse Events
IDegLira
Serious events: 14 serious events
Other events: 83 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 38 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegLira
n=288 participants at risk
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 participants at risk
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Investigations
Amylase increased
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Infections and infestations
Anal abscess
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Cardiac disorders
Arrhythmia
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Cardiac disorders
Atrioventricular block second degree
|
0.00%
0/288 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.68%
1/146 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Infections and infestations
Bronchitis
|
0.00%
0/288 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.68%
1/146 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Cardiac disorders
Cardiac failure congestive
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Surgical and medical procedures
Coronary revascularisation
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Infections and infestations
Dengue fever
|
0.00%
0/288 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.68%
1/146 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Injury, poisoning and procedural complications
Fall
|
0.69%
2/288 • Number of events 2 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Gastrointestinal disorders
Gastritis
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Nervous system disorders
Hypoglycaemic unconsciousness
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Vascular disorders
Hypotension
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.00%
0/288 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.68%
1/146 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Investigations
Lipase increased
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Infections and infestations
Meningitis haemophilus
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Eye disorders
Normal tension glaucoma
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pleural mesothelioma malignant
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Infections and infestations
Pyelonephritis chronic
|
0.35%
1/288 • Number of events 2 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
General disorders
Pyrexia
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Renal and urinary disorders
Renal cyst
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Renal and urinary disorders
Renal failure acute
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.00%
0/288 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.68%
1/146 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Nervous system disorders
Thalamic infarction
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.35%
1/288 • Number of events 1 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
0.00%
0/146 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
Other adverse events
| Measure |
IDegLira
n=288 participants at risk
In this arm, Subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. IDegLira was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Treatment with IDegLira was initiated at 10 dose steps containing 10 units insulin degludec and 0.36 mg liraglutide. Adjustment of the IDegLira dose was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
Placebo
n=146 participants at risk
In this arm, subjects suboptimally controlled on SU +/- metformin, were given s.c. injection of placebo solution (matched to IDegLira) and was initiated and titrated as described for IDegLira. SU and metformin were maintained at the stable pre-trial dose throughout the duration of the trial. Placebo solution was injected in the thigh, upper arm (deltoid region) or abdomen once daily preferably at the same time every day. The injection area chosen remained unchanged throughout the trial, but rotation within the area was recommended. Adjustment of placebo was performed twice weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-6.0 mmol/L).
|
|---|---|---|
|
Metabolism and nutrition disorders
Dyslipidaemia
|
6.6%
19/288 • Number of events 19 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
4.1%
6/146 • Number of events 7 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Nervous system disorders
Headache
|
5.2%
15/288 • Number of events 18 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
5.5%
8/146 • Number of events 11 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Infections and infestations
Influenza
|
2.8%
8/288 • Number of events 8 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
5.5%
8/146 • Number of events 9 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Investigations
Lipase increased
|
9.4%
27/288 • Number of events 29 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
4.1%
6/146 • Number of events 8 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
25/288 • Number of events 29 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
8.2%
12/146 • Number of events 15 • After 26 weeks of treatment
Safety analysis set included 434 subjects (288 in IDegLira and 146 in placebo).
|
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 pubication and/or communication for up to 60 days to protect intellectual property.
- Publication restrictions are in place
Restriction type: OTHER