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Comparison of NN1250 Versus Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

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ClinicalTrials.gov Identifier: NCT00982644
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : November 13, 2015
Last Update Posted : February 9, 2017
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
Drug: insulin glargine
Enrollment 1030
Recruitment Details The trial was conducted at 166 sites in 12 countries: Austria (6 sites), Belgium (5 sites), Canada (17 sites), Czech Republic (5 sites), Denmark (6 sites), Finland (6 sites), France (7 sites), Germany (16 sites), Norway (8 sites), Serbia (5 sites), Spain (9 sites) and United States (76 sites). Some subjects did not enrol in the extension period.
Pre-assignment Details All subjects who completed the 52-week main trial (NN51250-3579, NCT00982644) and when found to be eligible for the extension trial, were offered to participate in the 52-week extension trial (NN1250-3643). The total duration of treatment was up to 104 weeks (52 weeks + 52 weeks).
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period. Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Period Title: Main: Week 0 to 52 (NN1250-3579)
Started 773 257
Full Analysis Set 773 257
Exposed 766 [1] 257
Completed 607 197
Not Completed 166 60
Reason Not Completed
Adverse Event             20             5
Lack of Efficacy             7             2
Protocol Violation             46             18
Withdrawal criteria             9             5
Unclassified             84             30
[1]
7 subjects were withdrawn prior to exposure to trial products
Period Title: Extension: Week 53 to 104 (NN1250-3643)
Started 551 [1] 174 [2]
Completed 505 154
Not Completed 46 20
Reason Not Completed
Adverse Event             12             5
Lack of Efficacy             3             1
Protocol Violation             2             4
Withdrawal criteria             6             3
Unclassified             23             7
[1]
Fifty-six subjects did not continue into extension trial
[2]
Twenty-three subjects did not continue into extension trial
Arm/Group Title IDeg OD IGlar OD Total
Hide Arm/Group Description Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period. Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period. Total of all reporting groups
Overall Number of Baseline Participants 773 257 1030
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 773 participants 257 participants 1030 participants
59.3  (9.7) 58.7  (9.9) 59.1  (9.8)
Gender  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 773 participants 257 participants 1030 participants
Female
302
  39.1%
90
  35.0%
392
  38.1%
Male
471
  60.9%
167
  65.0%
638
  61.9%
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 773 participants 257 participants 1030 participants
8.2  (0.8) 8.2  (0.8) 8.2  (0.8)
Fasting plasma glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 773 participants 257 participants 1030 participants
9.6  (2.6) 9.7  (2.6) 9.7  (2.6)
1.Primary Outcome
Title Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
Hide Description Change from baseline in HbA1c after 52 weeks of treatment
Time Frame Week 0, Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The full analysis set (FAS) included all randomised subjects and missing data was imputed using last observation carried forward (LOCF).
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 773 257
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated haemoglobin
-1.06  (1.01) -1.19  (0.97)
2.Primary Outcome
Title Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Hide Description Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame Week 0 to Week 104 + 7 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 766 257
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
172 205
3.Primary Outcome
Title Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Hide Description Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Time Frame Week 0 to Week 104 + 7 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 766 257
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
27 46
4.Primary Outcome
Title Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Hide Description Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.
Time Frame Week 0 to Week 104 + 7 days of follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 766 257
Measure Type: Number
Unit of Measure: Events/100 years of patient exposure
Adverse event (AE) 362 339
Serious AE 15 17
Severe AE 14 17
Moderate AE 93 87
Mild AE 254 234
Fatal AE 0 1
5.Secondary Outcome
Title Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
Hide Description Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Time Frame Week 0 to Week 52 + 7 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 766 257
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
152 185
6.Secondary Outcome
Title Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment
Hide Description Change from baseline in HbA1c after 104 weeks of treatment
Time Frame Week 0, Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 773 257
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated haemoglobin
-0.95  (1.04) -1.11  (0.99)
7.Secondary Outcome
Title Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52
Hide Description Mean of 9-point SMPG at 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects and missing data was imputed using LOCF. For 126 subjects all 9-point SMPG values were missing.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 681 223
Mean (Standard Deviation)
Unit of Measure: mmol/L
7.7  (1.8) 7.7  (2.0)
8.Secondary Outcome
Title Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104
Hide Description Mean of 9-point SMPG at 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.
Time Frame Week 104
Hide Outcome Measure Data
Hide Analysis Population Description
The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 140 subjects all 9-point SMPG values were missing.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 666 224
Mean (Standard Deviation)
Unit of Measure: mmol/L
7.6  (1.9) 7.6  (1.9)
9.Secondary Outcome
Title Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
Hide Description Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occurring between 00:01 and 05:59 a.m.
Time Frame Week 0 to Week 52 + 7 days follow up
Hide Outcome Measure Data
Hide Analysis Population Description
The SAS included all subjects who received at least one dose of the investigational product or its comparator.
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
Overall Number of Participants Analyzed 766 257
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
25 39
Time Frame Adverse events were collected in a time frame of 104 weeks + 7 days follow up.
Adverse Event Reporting Description The SAS included all subjects who received at least one dose of investigational product or its comparator.
 
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description Insulin degludec (IDeg) was given subcutaneously (s.c) once daily (OD) with the main evening meal in combination with metformin with or without DPP-IV inhibitors. IDeg was given for 52 weeks in the main period and for another 52 weeks in the extension period. Insulin glargine (IGlar) was given subcutaneously (s.c) once daily (OD), according to the local labelling in combination with metformin with or without DPP-IV inhibitors. IGlar was given for 52 weeks in the main period and for another 52 weeks in the extension period.
All-Cause Mortality
IDeg OD IGlar OD
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
IDeg OD IGlar OD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   116/766 (15.14%)      41/257 (15.95%)    
Blood and lymphatic system disorders     
Anaemia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Cardiomyopathy  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Cardiac disorders     
Acute coronary syndrome  1  4/766 (0.52%)  4 0/257 (0.00%)  0
Angina pectoris  1  4/766 (0.52%)  4 2/257 (0.78%)  3
Angina unstable  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Atrial fibrillation  1  4/766 (0.52%)  4 2/257 (0.78%)  2
Atrial flutter  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Cardiac failure  1  2/766 (0.26%)  3 0/257 (0.00%)  0
Cardiac failure congestive  1  3/766 (0.39%)  4 2/257 (0.78%)  2
Cardiopulmonary failure  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Congestive cardiomyopathy  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Coronary artery disease  1  10/766 (1.31%)  11 0/257 (0.00%)  0
Coronary artery occlusion  1  2/766 (0.26%)  2 1/257 (0.39%)  1
Coronary artery stenosis  1  3/766 (0.39%)  3 2/257 (0.78%)  2
Mitral valve incompetence  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Myocardial infarction  1  3/766 (0.39%)  3 2/257 (0.78%)  2
Supraventricular tachycardia  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Tachyarrhythmia  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Tachycardia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Ventricular tachycardia  1  1/766 (0.13%)  2 0/257 (0.00%)  0
Acute left ventricular failure  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Acute myocardial ischaemia  1  5/766 (0.65%)  5 1/257 (0.39%)  1
Cardiac arrest  1  0/766 (0.00%)  0 1/257 (0.39%) 
Diastolic dysfunction  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Myocardial ishaemia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Sick sinus syndrome  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Ventricular fibrillation  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Ear and labyrinth disorders     
Vertigo  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Endocrine disorders     
Hyperparathyroidism primary  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Eye disorders     
Lens dislocation  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Macular oedema  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Retinal haemorrhage  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Gastrointestinal disorders     
Abdominal pain  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Colitis  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Colonic polyp  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Dyspepsia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Pancreatitis acute  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Umbilical hernia  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Abdominal discomfort  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Enterovesical fistula  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Gastric polyp  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Gastrointestinal haemorrhage  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Inguinal hernia  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Large intestinal perforation  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Lower grastrointestinal haemorrhage  1  1/766 (0.13%)  1 0/257 (0.00%)  0
General disorders     
Chest pain  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Hernia  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Death  1 [1]  1/766 (0.13%)  1 0/257 (0.00%)  0
Multiorgan failure  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Non-cardiac chest pain  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Hepatobiliary disorders     
Cholecystitis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Cholelithiasis obstructive  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Immune system disorders     
Hypersensitivity  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Infections and infestations     
Appendicitis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Bronchopneumonia  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Cellulitis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Diverticulitis  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Gastroenteritis  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Gastroenteritis viral  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Influenza  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Lobar pneumonia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Pneumonia  1  4/766 (0.52%)  4 2/257 (0.78%)  2
Pneumonia primary atypical  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Pyelonephritis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Urosepsis  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Vaginal infection  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Wound infection  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Abdominal abscess  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Diabetic foot  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Herpes zoster  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Meningitis listeria  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Pseudomembranous colitis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Pulmonary sepsis  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Skin graft infection  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Urinary tract infection  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Injury, poisoning and procedural complications     
Cervical vertebral fracture  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Contusion  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Fibula fracture  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Hand fracture  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Soft tissue injury  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Tooth fracture  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Fall  1  2/766 (0.26%)  2 0/257 (0.00%)  0
In-stent coronary artery restenosis  1  0/766 (0.00%)  0 1/257 (0.39%)  2
Incisional hernia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Lower limb fracture  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Meniscus lesion  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Muscle injury  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Post procedural haemorrhage  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Road traffic accident  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Hypoglycaemia  1  2/766 (0.26%)  2 2/257 (0.78%)  2
Hypoglycaemic unconsciousness  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Diabetic foot  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Rotator cuff syndrome  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Arthritis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Intervertebral disc protrusion  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Osteoarthritis  1  3/766 (0.39%)  3 2/257 (0.78%)  2
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Bladder adenocarcinoma stage unspecified  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Breast cancer  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Colon cancer  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Prostate cancer stage I  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Thyroid cancer  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Benign neoplasm of bladder  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Benign neoplasm of prostate  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Bladder transitional cell carcinoma  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Bladder transitional cell carcinoma  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Bronchoalveolar carcinoma  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Colon carcinoma stage 3  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Diffuse large B cell lymphoma  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Prostate carcinoma  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Rectal carcinoma  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Renal cell carcinoma stage 1  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Small cell lung cancer  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Cerebro vascular accident  1  4/766 (0.52%)  5 0/257 (0.00%)  0
Embolic cerebral infarction  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Nervous system disorders     
Aphasia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Carotid artery stenosis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Cerebral infarction  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Cerebrospinal fistula  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Cervicobrachial syndrome  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Hypoaesthesia  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Ischaemic stroke  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Syncope  1  3/766 (0.39%)  3 1/257 (0.39%)  1
Thalamic infarction  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Hypoglycaemic unconsciousness  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Sciatica  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Psychiatric disorders     
Depression  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Renal and urinary disorders     
Calculus bladder  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Nephrolithiasis  1  2/766 (0.26%)  2 1/257 (0.39%)  1
Calculus urinary  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Renal cyst  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Renal failure acute  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Urethral stenosis  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Urinary retention  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Reproductive system and breast disorders     
Benign prostatic hyperplasia  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Vaginal haemorrhage  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Respiratory, thoracic and mediastinal disorders     
Chronic obstructive pulmonary disease  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Epistaxis  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Pulmonary oedema  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Acute pulmonary oedema  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Dyspnoea  1  1/766 (0.13%)  1 1/257 (0.39%)  1
Nasal polyp  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Respiratory acidosis  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Surgical and medical procedures     
Inguinal hernia repair  1  1/766 (0.13%)  1 0/257 (0.00%)  0
Vascular disorders     
Hypertensive crisis  1  2/766 (0.26%)  2 0/257 (0.00%)  0
Orthostatic hypotension  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Peripheral vascular disorder  1  0/766 (0.00%)  0 2/257 (0.78%)  2
Hypertension  1  0/766 (0.00%)  0 1/257 (0.39%)  1
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
[1]
Cause: Unknown
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
IDeg OD IGlar OD
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   463/766 (60.44%)      153/257 (59.53%)    
Gastrointestinal disorders     
Diarrhoea  1  83/766 (10.84%)  126 28/257 (10.89%)  36
Vomiting  1  34/766 (4.44%)  44 17/257 (6.61%)  20
Nausea  1  41/766 (5.35%)  55 11/257 (4.28%)  17
Gastroenteritis  1  34/766 (4.44%)  40 15/257 (5.84%)  16
General disorders     
Oedema peripheral  1  46/766 (6.01%)  55 11/257 (4.28%)  12
Infections and infestations     
Bronchitis  1  70/766 (9.14%)  99 20/257 (7.78%)  23
Nasopharyngitis  1  183/766 (23.89%)  310 65/257 (25.29%)  108
Upper respiratory tract infection  1  78/766 (10.18%)  121 19/257 (7.39%)  33
Influenza  1  44/766 (5.74%)  50 13/257 (5.06%)  18
Urinary tract infection  1  45/766 (5.87%)  64 14/257 (5.45%)  17
Musculoskeletal and connective tissue disorders     
Back pain  1  76/766 (9.92%)  129 23/257 (8.95%)  39
Arthralgia  1  45/766 (5.87%)  57 12/257 (4.67%)  14
Musculoskeletal pain  1  30/766 (3.92%)  37 13/257 (5.06%)  14
Pain In Extremity  1  44/766 (5.74%)  53 11/257 (4.28%)  11
Nervous system disorders     
Headache  1  106/766 (13.84%)  192 30/257 (11.67%)  57
Dizziness  1  31/766 (4.05%)  40 14/257 (5.45%)  18
Respiratory, thoracic and mediastinal disorders     
Cough  1  61/766 (7.96%)  80 14/257 (5.45%)  20
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 14.1
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.
Novo Nordisk maintains the right to be informed of any Investigator plans for publication and to review any scientific paper, presentation, communication or other information concerning the investigation described in this protocol. Any such communication must be submitted in writing to the Novo Nordisk trial manager prior to submission for comments. Comments will be given within four weeks from receipt of the planned communication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Public Access to Clinical Trials
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: NCT00982644     History of Changes
Obsolete Identifiers: NCT01193309
Other Study ID Numbers: NN1250-3579
2008-005776-27 ( EudraCT Number )
U1111-1111-8692 ( Other Identifier: WHO )
2009-015754-38 ( EudraCT Number )
U1111-1114-9426 ( Other Identifier: WHO )
First Submitted: September 22, 2009
First Posted: September 23, 2009
Results First Submitted: October 14, 2015
Results First Posted: November 13, 2015
Last Update Posted: February 9, 2017