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Comparison of NN1250 Plus Insulin Aspart With Insulin Glargine Plus Insulin Aspart in Type 1 Diabetes (BEGIN™)

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ClinicalTrials.gov Identifier: NCT00982228
Recruitment Status : Completed
First Posted : September 23, 2009
Results First Posted : December 29, 2015
Last Update Posted : April 6, 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 1
Interventions Drug: insulin degludec
Drug: insulin glargine
Drug: insulin aspart
Enrollment 629
Recruitment Details The trial was conducted at 79 sites in 6 countries: France (6), Germany (5), Russia (7), South Africa (3), United Kingdom (U.K.) (6) and United States (U.S.) (52).
Pre-assignment Details All subjects who completed the 52-week main trial (NN1250-3583, NCT00982228) and were found to be eligible for the extension trial were offered to participate in the 52-week extension trial (NN1250-3644).
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period. Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Period Title: Main: Week 0 to 52 (NN1250-3583)
Started 472 157
Full Analysis Set 472 157
Exposed 472 154 [1]
Completed 404 137
Not Completed 68 20
Reason Not Completed
Adverse Event             12             2
Lack of Efficacy             2             0
Protocol Violation             11             2
Withdrawal criteria             15             3
Unclassified             28             13
[1]
Three subjects withdrew prior to exposure to trial drug
Period Title: Extension: Week 53 to 104 (NN1250-3644)
Started 351 [1] 118 [2]
Completed 330 113
Not Completed 21 5
Reason Not Completed
Adverse Event             3             2
Lack of Efficacy             1             0
Protocol Violation             1             2
Withdrawal criteria             5             0
Unclassified             11             1
[1]
Fifty-three subjects from the main trial did not continue into the extension
[2]
Nineteen subjects from the main trial did not continue into the extension
Arm/Group Title IDeg OD IGlar OD Total
Hide Arm/Group Description Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period. Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period. Total of all reporting groups
Overall Number of Baseline Participants 472 157 629
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 472 participants 157 participants 629 participants
42.8  (13.7) 43.7  (13.3) 43.0  (13.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 472 participants 157 participants 629 participants
Female
194
  41.1%
67
  42.7%
261
  41.5%
Male
278
  58.9%
90
  57.3%
368
  58.5%
Glycosylated haemoglobin (HbA1c)  
Mean (Standard Deviation)
Unit of measure:  Percentage of glycosylated haemoglobin
Number Analyzed 472 participants 157 participants 629 participants
7.7  (0.9) 7.7  (1.0) 7.7  (1.0)
Fasting plasma glucose (FPG)  
Mean (Standard Deviation)
Unit of measure:  mmol/L
Number Analyzed 472 participants 157 participants 629 participants
9.1  (4.0) 9.7  (4.4) 9.3  (4.1)
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 LOCF (last observation carried forward).
Arm/Group Title IDeg OD IGlar OD
Hide Arm/Group Description:
Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 472 157
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated haemoglobin
-0.40  (0.73) -0.39  (0.84)
2.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 follow up
Hide Outcome Measure Data
Hide Analysis Population Description
Safety analysis set (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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 472 154
Measure Type: Number
Unit of Measure: Events/100 years of patient exposure
Adverse events (AE) 383 374
Serious AE 14 17
Severe AE 22 26
Moderate AE 105 106
Mild AE 256 242
Fatal AE 1 1
3.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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 472 154
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
3750 3743
4.Primary Outcome
Title Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin
Hide Description The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.
Time Frame Week 0, Week 106
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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 335 111
Mean (Standard Deviation)
Unit of Measure: %B/T
11.3  (15.6) 11.0  (16.0)
5.Secondary 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 occuring 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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 472 154
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
390 532
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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 472 157
Mean (Standard Deviation)
Unit of Measure: percentage of glycosylated haemoglobin
-0.27  (0.75) -0.24  (0.86)
7.Secondary Outcome
Title Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment
Hide Description Mean of 9-point self-measured plasma glucose profile (SMPG) after 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 Treatment 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 12 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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 463 154
Mean (Standard Deviation)
Unit of Measure: mmol/L
8.0  (2.2) 8.1  (2.2)
8.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 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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 472 154
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
4254 4018
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 occuring 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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 472 154
Measure Type: Number
Unit of Measure: Episodes/100 years of patient exposure
441 586
10.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 self-measured plasma glucose profile (SMPG) after 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 7 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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
Overall Number of Participants Analyzed 467 155
Mean (Standard Deviation)
Unit of Measure: mmol/L
8.1  (2.3) 8.3  (2.4)
Time Frame The adverse events were collected in a time frame of 104 weeks + 1 week after last dose in main trial + 1 more week after last dose in extension trial.
Adverse Event Reporting 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) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period. Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 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   71/472 (15.04%)      29/154 (18.83%)    
Cardiac disorders     
Acute myocardial infarction  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Myocardial infarction  1  2/472 (0.42%)  2 1/154 (0.65%)  1
Bundle branch block left  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Coronary artery disease  1  2/472 (0.42%)  2 0/154 (0.00%)  0
Pericarditis  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Ventricular arrhythmia  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Ventricular Tachycardia  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Ear and labyrinth disorders     
Tympanic membrane perforation  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Gastrointestinal disorders     
Colitis  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Diabetic gastroparesis  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Gastritis  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Inguinal hernia  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Melaena  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Salivary gland calculus  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Gastric ulcer  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Pancreatic pseudocyst  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Pancreatitis acute  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Vomiting  1  1/472 (0.21%)  1 0/154 (0.00%)  0
General disorders     
Sudden death  1  1/472 (0.21%)  1 1/154 (0.65%)  1
Hepatobiliary disorders     
Cholelithiasis  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Immune system disorders     
Allergy to animal  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Infections and infestations     
Cellulitis  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Cholecystitis infective  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Gastroenteritis  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Pneumonia  1  1/472 (0.21%)  1 1/154 (0.65%)  1
Pulmonary tuberculoma  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Pulmonary tuberculosis  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Appendicitis  1  1/472 (0.21%)  1 1/154 (0.65%)  1
Upper respiratory tract infection  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Injury, poisoning and procedural complications     
Forearm fracture  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Incorrect dose administered  1  2/472 (0.42%)  2 0/154 (0.00%)  0
Joint injury  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Pneumothorax traumatic  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Road traffic accident  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Accidental Overdose  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Cervical vertebral fracture  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Hip fracture  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Injury  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Tendon Rupture  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  2/472 (0.42%)  2 3/154 (1.95%)  3
Hypoglycaemia  1  27/472 (5.72%)  38 7/154 (4.55%)  10
Hypoglycaemic seizure  1  3/472 (0.64%)  3 2/154 (1.30%)  2
Hypoglycaemic unconsciousness  1  15/472 (3.18%)  20 4/154 (2.60%)  4
Musculoskeletal and connective tissue disorders     
Arthritis reactive  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Bone pain  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Musculoskeletal chest pain  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Tenosynovitis  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Neck pain  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Osteonecrosis  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Squamous cell carcinoma  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Thyroid cancer  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Gallbladder cancer metastatic  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Glioblastoma  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Oesophageal adenocarcinoma  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Nervous system disorders     
Convulsion  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Hypoglycaemic coma  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Transient ischaemic attack  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Headache  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Hypoglycaemic encephalopathy  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Syncope  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Renal and urinary disorders     
Nephrolithiasis  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Renal failure acute  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Reproductive system and breast disorders     
Cervical dysplasia  1  0/472 (0.00%)  0 1/154 (0.65%)  1
Respiratory, thoracic and mediastinal disorders     
Epistaxis  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Skin and subcutaneous tissue disorders     
Skin ulcer  1  1/472 (0.21%)  1 0/154 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (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   353/472 (74.79%)      118/154 (76.62%)    
Gastrointestinal disorders     
Diarrhoea  1  39/472 (8.26%)  44 9/154 (5.84%)  12
Nausea  1  40/472 (8.47%)  57 14/154 (9.09%)  18
Vomiting  1  25/472 (5.30%)  26 11/154 (7.14%)  15
Immune system disorders     
Seasonal allergy  1  10/472 (2.12%)  11 10/154 (6.49%)  10
Infections and infestations     
Bronchitis  1  38/472 (8.05%)  46 11/154 (7.14%)  17
Gastroenteritis  1  44/472 (9.32%)  49 9/154 (5.84%)  10
Influenza  1  44/472 (9.32%)  53 17/154 (11.04%)  19
Nasopharyngitis  1  160/472 (33.90%)  284 51/154 (33.12%)  105
Sinusitis  1  58/472 (12.29%)  93 23/154 (14.94%)  31
Upper respiratory tract infection  1  122/472 (25.85%)  208 31/154 (20.13%)  48
Urinary tract infection  1  35/472 (7.42%)  40 12/154 (7.79%)  16
Gastrointestinal viral  1  25/472 (5.30%)  27 6/154 (3.90%)  9
Injury, poisoning and procedural complications     
Wrong drug administered  1  31/472 (6.57%)  35 6/154 (3.90%)  6
Metabolism and nutrition disorders     
Hypoglycaemia  1  44/472 (9.32%)  70 13/154 (8.44%)  18
Musculoskeletal and connective tissue disorders     
Back Pain  1  33/472 (6.99%)  46 9/154 (5.84%)  15
Nervous system disorders     
Headache  1  84/472 (17.80%)  162 22/154 (14.29%)  39
Respiratory, thoracic and mediastinal disorders     
Cough  1  33/472 (6.99%)  37 17/154 (11.04%)  19
Oropharyngeal pain  1  34/472 (7.20%)  46 14/154 (9.09%)  19
Nasal congestion  1  17/472 (3.60%)  18 11/154 (7.14%)  13
Sinus congestion  1  22/472 (4.66%)  25 9/154 (5.84%)  12
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (Unknown)
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
Name/Title: Public Access to Clinical Trials
Organization: Novo Nordisk A/S
Publications of Results:
Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00982228     History of Changes
Obsolete Identifiers: NCT01198041
Other Study ID Numbers: NN1250-3583
2008-005774-13 ( EudraCT Number )
U1111-1111-8789 ( Other Identifier: WHO )
2009-015755-24 ( EudraCT Number )
U1111-1116-1578 ( Other Identifier: WHO )
First Submitted: September 22, 2009
First Posted: September 23, 2009
Results First Submitted: October 14, 2015
Results First Posted: December 29, 2015
Last Update Posted: April 6, 2017