Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Dual Action of Liraglutide and Insulin Degludec in Type 2 Diabetes: A Trial Comparing the Efficacy and Safety of Insulin Degludec/Liraglutide, Insulin Degludec and Liraglutide in Subjects With Type 2 Diabetes (DUAL™ I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01336023
Recruitment Status : Completed
First Posted : April 15, 2011
Results First Posted : June 2, 2017
Last Update Posted : February 19, 2018
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Diabetes
Diabetes Mellitus, Type 2
Interventions Drug: insulin degludec/liraglutide
Drug: insulin degludec
Drug: liraglutide
Enrollment 1663
Recruitment Details Countries: 19; Sites: 271; Number of sites as in parenthesis. Australia (7), Canada (14 ), Finland (5 ), Germany (12 ), Hungary (6), India (23), Ireland (2), Italy (6), Malaysia (5), Mexico (2 ), Russian Federation (11), Singapore (3), Slovakia (5), South Africa (13), Spain (8), Taiwan (3), Thailand (4), United Kingdom (16) and United States (126).
Pre-assignment Details Subjects on metformin and/or pioglitazone treatment underwent a 26-week main trial and continued to enter an additional 26-week extension trial. Total duration of the trial was up to 55 weeks (2 weeks screening + 26 week main period + 26 week extension period + 1 week follow-up after last dose).
Arm/Group Title IDeg IDegLira Liraglutide
Hide Arm/Group Description Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial. Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial. Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Period Title: Week 0 to Week 26
Started 414 834 415
Exposed 413 [1] 826 [2] 413 [3]
Completed 366 736 342
Not Completed 48 98 73
Reason Not Completed
Adverse Event             8             10             24
Lack of Efficacy             0             1             0
Protocol Violation             1             2             0
Withdrawal Criteria             34             69             40
Unclassified             5             16             9
[1]
1 subject withdrew before exposure to trial drug and was not included in the analysis
[2]
8 subjects withdrew before exposure to trial drug and were not included in the analysis
[3]
2 subjects withdrew before exposure to trial drug and were not included in the analysis
Period Title: Week 27 to 52
Started 333 [1] 665 [2] 313 [3]
Completed 305 621 285
Not Completed 28 44 28
Reason Not Completed
Adverse Event             1             5             2
Protocol Violation             0             2             1
Withdrawal Criteria             14             19             16
Unclassified             13             18             9
[1]
From the main trial, 33 subjects were not enrolled in the extension (week 27-52).
[2]
From the main trial, 71 subjects were not enrolled in the extension (week 27-52).
[3]
From the main trial, 29 subjects were not enrolled in the extension (week 27-52).
Arm/Group Title IDeg IDegLira Liraglutide Total
Hide Arm/Group Description Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial. Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial. Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial. Total of all reporting groups
Overall Number of Baseline Participants 413 833 414 1660
Hide Baseline Analysis Population Description
The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF). Three subjects did not have their case book signed off due to discontinuation of an investigator's participation in the trial, hence 1 subject in each arm was excluded from the FAS.
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 413 participants 833 participants 413 participants 1659 participants
54.9  (9.7) 55.1  (9.9) 55.0  (10.2) 55.0  (9.9)
[1]
Measure Analysis Population Description: The number of subjects analysed in the IDeg, IDegLira and Liraglutide arms 413, 833 and 413, respectively.
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 413 participants 833 participants 414 participants 1660 participants
Female
213
  51.6%
398
  47.8%
206
  49.8%
817
  49.2%
Male
200
  48.4%
435
  52.2%
208
  50.2%
843
  50.8%
Body Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 413 participants 833 participants 414 participants 1660 participants
87.4  (19.2) 87.2  (19.0) 87.4  (18.0) 87.3  (18.8)
Normalised Incremental Area under curve (AUC)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 63 participants 128 participants 61 participants 252 participants
4.12  (1.80) 4.11  (2.05) 4.12  (1.82) 4.11  (1.93)
[1]
Measure Description: The area under the glucose concentration (AUC) curve during 0-4 hours after the start of a standardised meal. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L. The data was derived from the subjects who underwent a standard meal test conducted at selected sites.
[2]
Measure Analysis Population Description: The number of subjects analysed in the IDeg, IDegLira and Liraglutide arms 63, 128 and 61, respectively.
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 413 participants 833 participants 414 participants 1660 participants
8.3  (1.0) 8.3  (0.9) 8.3  (0.9) 8.3  (0.9)
1.Primary Outcome
Title Mean Change From Baseline in HbA1c (Glycosylated Haemoglobin) at Week 26.
Hide Description Values of mean change in HbA1c.
Time Frame Week 0, week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator's participation in the trial; hence 1 subject from each arm was excluded from the FAS.
Arm/Group Title IDeg IDegLira Liraglutide
Hide Arm/Group Description:
Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Overall Number of Participants Analyzed 413 833 414
Mean (Standard Deviation)
Unit of Measure: Percentage of glycosylated haemoglobin
-1.44  (1.03) -1.91  (1.07) -1.28  (1.13)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection IDeg, IDegLira
Comments [Not Specified]
Type of Statistical Test Non-Inferiority
Comments

Non-inferiority of IDegLira vs. IDeg was confirmed when 95% confidence interval for the treatment differences for change in HbA1c lies entirely below 0.3%.

IDegLira minus IDeg

Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment Contrast
Estimated Value -0.47
Confidence Interval (2-Sided) 95%
-0.58 to -0.36
Estimation Comments IDegLira minus IDeg
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection IDegLira, Liraglutide
Comments [Not Specified]
Type of Statistical Test Superiority
Comments

Superiority of IDegLira over liraglutide was confirmed when the 95% confidence interval for the treatment difference for change in HbA1c lies entirely below 0%.

IDegLira minus Liraglutide

Statistical Test of Hypothesis P-Value [Not Specified]
Comments [Not Specified]
Method ANCOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Treatment contrast
Estimated Value -0.64
Confidence Interval (2-Sided) 95%
-0.75 to -0.53
Estimation Comments IDegLira minus Liraglutide
2.Secondary Outcome
Title Mean Change From Baseline in Body Weight at Week 26
Hide Description Values of mean change in body weight.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects and missing data was imputed using LOCF. Three subjects did not have their case book signed off due to discontinuation of an investigator's participation in the trial; hence 1 subject from each arm was excluded from the FAS.
Arm/Group Title IDeg IDegLira Liraglutide
Hide Arm/Group Description:
Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Overall Number of Participants Analyzed 413 833 414
Mean (Standard Deviation)
Unit of Measure: kg
1.6  (4.0) -0.5  (3.5) -3.0  (3.5)
3.Secondary Outcome
Title Number of Hypoglycaemic Episodes
Hide Description Reported hypoglycemaic episodes are number of hypoglycemic events per 100 patient years of exposure.
Time Frame Weeks 0-26
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparators. The missing data was imputed using LOCF. The number of subjects analysed in SAS for each arm are 412, 825 and 412, respectively.
Arm/Group Title IDeg IDegLira Liraglutide
Hide Arm/Group Description:
Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Overall Number of Participants Analyzed 412 825 412
Measure Type: Number
Unit of Measure: Events per 100 patient years of exposure
256.7 180.2 22.0
4.Secondary Outcome
Title Change From Baseline in Incremental Area Under the Curve 0-4h (iAUC0-4h) Derived From the Glucose Concentration Profile During Meal Test
Hide Description Values of mean change in normalised iAUC0-4h values based on LOCF data derived from the glucose concentration profiles during a meal test. The meal test was performed at selected sites at baseline and after 26 weeks of treatment in the main trial period. The incremental AUC was calculated using the trapezoidal method and the resulting area was divided length of the observation period to yield the (normalised) prandial increment in mmol/L using the available valid glucose observations and the associated actual elapsed time point.
Time Frame Week 0, Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The number of subjects analysed were equal to study population in which the meal test was perfomed at selected sites. Missing data was imputed using LOCF.
Arm/Group Title IDeg IDegLira Liraglutide
Hide Arm/Group Description:
Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Overall Number of Participants Analyzed 63 128 61
Mean (Standard Deviation)
Unit of Measure: mmol/L
-0.17  (1.98) -0.87  (1.65) -0.78  (1.62)
5.Secondary Outcome
Title Mean Actual Daily Insulin Dose
Hide Description Mean of the actual doses recorded at visit 28 (Week 26).
Time Frame Week 26
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects. Missing data was imputed using LOCF. For 22 subjects, the dose values were missing hence did not contribute to the analysis. The comparison was made between the insulin products IDeg and IDeglira.
Arm/Group Title IDeg IDegLira
Hide Arm/Group Description:
Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
Overall Number of Participants Analyzed 408 816
Mean (Standard Deviation)
Unit of Measure: units
53  (28) 38  (13)
Time Frame Adverse events (AEs) were collected from first day of exposure to randomised treatment of 52 weeks (26 week main period + 26 week extension period) + 7 days follow-up after the last day on randomised treatment.
Adverse Event Reporting Description The Safety Analysis Set (SAS) included all subjects receiving at least one dose of the investigational product or comparators.
 
Arm/Group Title IDeg IDegLira Liraglutide
Hide Arm/Group Description Insulin degludec (IDeg: 100 U/mL) was injected once daily (OD) subcutaneously (s.c.) for 26 weeks (main trial) + 26 weeks (extension trial). IDeg treatment was initiated at a dose of 10 units and titrated twice weekly to the fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean fasting self-measured plasma glucose (SMPG) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial. Insulin Degludec/Liraglutide (IDegLira: 100 U/3.6 mg per mL) was injected subcutaneously OD for 26 weeks(main trial) + 26 weeks (extension trial). IDegLira treatment was initiated at 10 dose steps (containing 10 units IDeg and 0.36 mg liraglutide) and titrated twice weekly to a fasting glycaemic target of 4.0-5.0 mmol/L (72-90 mg/dL) based on the mean SMPG (fasting) from 3 preceeding measurements. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial. Liraglutide (6 mg/mL) was injected subcutaneously OD for 26 weeks (main trial). Liraglutide treatment was initiated at a dose of 0.6 mg/day, and subsequently increased by 0.6 mg in weekly dose escalation steps to reach maximum dose of 1.8 mg/day. Subjects continued with liraglutide 1.8 mg once daily in the 26 week extension period. Pre-trial metformin/metformin + pioglitazone treatment was continued throughout the trial.
All-Cause Mortality
IDeg IDegLira Liraglutide
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Hide Serious Adverse Events
IDeg IDegLira Liraglutide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   22/412 (5.34%)      38/825 (4.61%)      24/412 (5.83%)    
Cardiac disorders       
Acute coronary syndrome  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Acute myocardial infarction  1  1/412 (0.24%)  1 2/825 (0.24%)  2 1/412 (0.24%)  1
Angina pectoris  1  0/412 (0.00%)  0 2/825 (0.24%)  2 2/412 (0.49%)  2
Angina unstable  1  2/412 (0.49%)  2 0/825 (0.00%)  0 0/412 (0.00%)  0
Atrial fibrillation  1  0/412 (0.00%)  0 1/825 (0.12%)  1 1/412 (0.24%)  1
Coronary artery dilatation  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Coronary artery disease  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Myocardial ischaemia  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Endocrine disorders       
Goitre  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Eye disorders       
Angle closure glaucoma  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Cataract  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Necrotising retinitis  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Vitreous haemorrhage  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Gastrointestinal disorders       
Colitis ischaemic  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Gastritis  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Gastrointestinal haemorrhage  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Gastrooesophageal reflux disease  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  2
Pancreatitis acute  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Small intestinal obstruction  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Umbilical hernia  1  0/412 (0.00%)  0 0/825 (0.00%)  0 2/412 (0.49%)  2
Vomiting  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
General disorders       
Death  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Pyrexia  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Hepatobiliary disorders       
Biliary colic  1  0/412 (0.00%)  0 2/825 (0.24%)  2 0/412 (0.00%)  0
Cholecystitis  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Cholelithiasis  1  2/412 (0.49%)  2 0/825 (0.00%)  0 1/412 (0.24%)  1
Jaundice cholestatic  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Infections and infestations       
Abscess  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Appendicitis perforated  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Bronchitis  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Diverticulitis  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Gastroenteritis  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Gastroenteritis viral  1  1/412 (0.24%)  1 0/825 (0.00%)  0 1/412 (0.24%)  1
Localised infection  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Septic shock  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Subcutaneous abscess  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Urinary tract infection  1  1/412 (0.24%)  1 1/825 (0.12%)  1 1/412 (0.24%)  1
Injury, poisoning and procedural complications       
Fall  1  1/412 (0.24%)  1 1/825 (0.12%)  1 0/412 (0.00%)  0
Foot fracture  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Road traffic accident  1  0/412 (0.00%)  0 1/825 (0.12%)  1 1/412 (0.24%)  1
Spinal fracture  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Wrong drug administered  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Metabolism and nutrition disorders       
Hypoglycaemia  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Obesity  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Intervertebral disc protrusion  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Lumbar spinal stenosis  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Musculoskeletal pain  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Osteoarthritis  1  0/412 (0.00%)  0 1/825 (0.12%)  1 3/412 (0.73%)  3
Pseudarthrosis  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Tendonitis  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Bladder cancer stage 0, with cancer in situ  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Endometrial cancer stage III  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Inflammatory carcinoma of breast stage III  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Malignant melanoma  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Pancreatic carcinoma stage IV  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Plasmacytoma  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Prostate cancer  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Prostate cancer stage II  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Thyroid neoplasm  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Nervous system disorders       
Complicated migraine  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Guillain-Barre syndrome  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Hypertensive encephalopathy  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Hypoglycaemic unconsciousness  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Syncope  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Psychiatric disorders       
Anxiety  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Renal and urinary disorders       
Nephrolithiasis  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Renal colic  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Renal failure  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Renal failure acute  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Renal impairment  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Reproductive system and breast disorders       
Benign prostatic hyperplasia  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Dysfunctional uterine bleeding  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Bronchitis chronic  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Chronic obstructive pulmonary disease  1  2/412 (0.49%)  3 0/825 (0.00%)  0 0/412 (0.00%)  0
Lung consolidation  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Pleural effusion  1  1/412 (0.24%)  1 0/825 (0.00%)  0 0/412 (0.00%)  0
Skin and subcutaneous tissue disorders       
Stevens-Johnson syndrome  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Surgical and medical procedures       
Coronary arterial stent insertion  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Coronary artery bypass  1  1/412 (0.24%)  1 2/825 (0.24%)  2 0/412 (0.00%)  0
Coronary revascularisation  1  1/412 (0.24%)  1 1/825 (0.12%)  1 0/412 (0.00%)  0
Percutaneous coronary intervention  1  0/412 (0.00%)  0 0/825 (0.00%)  0 1/412 (0.24%)  1
Vascular disorders       
Femoral arterial stenosis  1  0/412 (0.00%)  0 1/825 (0.12%)  1 0/412 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IDeg IDegLira Liraglutide
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   160/412 (38.83%)      386/825 (46.79%)      241/412 (58.50%)    
Gastrointestinal disorders       
Constipation  1  4/412 (0.97%)  4 26/825 (3.15%)  34 21/412 (5.10%)  23
Diarrhoea  1  28/412 (6.80%)  33 84/825 (10.18%)  128 67/412 (16.26%)  94
Dyspepsia  1  5/412 (1.21%)  5 28/825 (3.39%)  35 22/412 (5.34%)  28
Nausea  1  16/412 (3.88%)  21 85/825 (10.30%)  102 92/412 (22.33%)  118
Vomiting  1  10/412 (2.43%)  10 41/825 (4.97%)  62 37/412 (8.98%)  54
Infections and infestations       
Nasopharyngitis  1  52/412 (12.62%)  74 115/825 (13.94%)  162 55/412 (13.35%)  81
Upper respiratory tract infection  1  34/412 (8.25%)  40 64/825 (7.76%)  79 33/412 (8.01%)  37
Investigations       
Lipase increased  1  18/412 (4.37%)  20 48/825 (5.82%)  55 35/412 (8.50%)  40
Metabolism and nutrition disorders       
Decreased appetite  1  2/412 (0.49%)  2 22/825 (2.67%)  23 30/412 (7.28%)  32
Musculoskeletal and connective tissue disorders       
Arthralgia  1  15/412 (3.64%)  23 30/825 (3.64%)  36 22/412 (5.34%)  27
Back pain  1  20/412 (4.85%)  23 45/825 (5.45%)  45 23/412 (5.58%)  29
Nervous system disorders       
Dizziness  1  10/412 (2.43%)  14 24/825 (2.91%)  30 22/412 (5.34%)  25
Headache  1  45/412 (10.92%)  143 106/825 (12.85%)  207 60/412 (14.56%)  100
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA Version 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
At the end of the trial, one or more manuscripts for publication will be prepared collaboratively between Investigator(s) and Novo Nordisk. Novo Nordisk reserves the right to postpone publication and/or communication for less than 60 days to protect intellectual property.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Global Clinical Registry (GCR, 1452)
Organization: Novo Nordisk A/S
EMail: clinicaltrials@novonordisk.com
Publications of Results:
Layout table for additonal information
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01336023    
Other Study ID Numbers: NN9068-3697
U1111-1119-1174 ( Other Identifier: WHO )
2010-021560-15 ( EudraCT Number )
First Submitted: April 13, 2011
First Posted: April 15, 2011
Results First Submitted: December 12, 2016
Results First Posted: June 2, 2017
Last Update Posted: February 19, 2018