Trial Outcomes & Findings for Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes (NCT NCT01045707)
NCT ID: NCT01045707
Last Updated: 2016-12-08
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
530 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2016-12-08
Participant Flow
The trial was conducted at 88 sites in 8 countries: Austria (4), India (7), South Korea (5), Poland (6), Russia (10), Spain (11), Turkey (5), and United States of America (40). Some sites did not enroll subjects in the extension period.
The total duration of treatment was up to 52 weeks (26 weeks \[main trial: NN5401-3590, NCT01045707\] + 26 weeks \[extension trial: NN5401-3726\]), separated by 1 week of wash-out period; during which subjects were treated with Neutral Protamine Hagedorn (NPH) insulin twice daily (BID) in combination with subject's pre-trial treatment of metformin.
Participant milestones
| Measure |
IDegAsp OD
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Main: Week 0 to 26 (NN5401-3590)
STARTED
|
266
|
264
|
|
Main: Week 0 to 26 (NN5401-3590)
Exposed
|
265
|
261
|
|
Main: Week 0 to 26 (NN5401-3590)
COMPLETED
|
219
|
232
|
|
Main: Week 0 to 26 (NN5401-3590)
NOT COMPLETED
|
47
|
32
|
|
Extension: Week 27 to 52 (NN5401-3726)
STARTED
|
192
|
221
|
|
Extension: Week 27 to 52 (NN5401-3726)
COMPLETED
|
179
|
209
|
|
Extension: Week 27 to 52 (NN5401-3726)
NOT COMPLETED
|
13
|
12
|
Reasons for withdrawal
| Measure |
IDegAsp OD
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Main: Week 0 to 26 (NN5401-3590)
Adverse Event
|
5
|
3
|
|
Main: Week 0 to 26 (NN5401-3590)
Lack of Efficacy
|
4
|
2
|
|
Main: Week 0 to 26 (NN5401-3590)
Protocol Violation
|
6
|
5
|
|
Main: Week 0 to 26 (NN5401-3590)
Withdrawal Criteria
|
22
|
11
|
|
Main: Week 0 to 26 (NN5401-3590)
Unclassified
|
10
|
11
|
|
Extension: Week 27 to 52 (NN5401-3726)
Adverse Event
|
3
|
3
|
|
Extension: Week 27 to 52 (NN5401-3726)
Protocol Violation
|
2
|
3
|
|
Extension: Week 27 to 52 (NN5401-3726)
Withdrawal criteria
|
2
|
1
|
|
Extension: Week 27 to 52 (NN5401-3726)
Unclassified
|
6
|
5
|
Baseline Characteristics
Comparison of NN5401 Versus Insulin Glargine, Both Combined With Metformin Treatment, in Subjects With Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDegAsp OD
n=266 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=263 Participants
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
Total
n=529 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
57.4 years
STANDARD_DEVIATION 9.0 • n=5 Participants
|
56.4 years
STANDARD_DEVIATION 9.2 • n=7 Participants
|
56.9 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Gender
Female
|
141 Participants
n=5 Participants
|
127 Participants
n=7 Participants
|
268 Participants
n=5 Participants
|
|
Gender
Male
|
125 Participants
n=5 Participants
|
136 Participants
n=7 Participants
|
261 Participants
n=5 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.9 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 1.0 • n=5 Participants
|
8.9 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=7 Participants
|
8.9 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=5 Participants
|
|
Fasting plasma glucose (FPG)
|
10.1 mmol/L
STANDARD_DEVIATION 2.9 • n=5 Participants
|
10.4 mmol/L
STANDARD_DEVIATION 2.8 • n=7 Participants
|
10.2 mmol/L
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: Week 0, Week 26Population: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.
Change from baseline in HbA1c after 26 weeks of treatment.
Outcome measures
| Measure |
IDegAsp OD
n=266 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=263 Participants
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 26 Weeks of Treatment
|
-1.65 percentage of glycosylated haemoglobin
Standard Deviation 1.28
|
-1.72 percentage of glycosylated haemoglobin
Standard Deviation 1.17
|
PRIMARY outcome
Timeframe: Week 0 to Week 53 + 7 days follow upPopulation: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
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.
Outcome measures
| Measure |
IDegAsp OD
n=265 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=261 Participants
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes
|
419 Episodes/100 years of patient exposure
|
211 Episodes/100 years of patient exposure
|
PRIMARY outcome
Timeframe: Week 0 to Week 53 + 7 days follow upPopulation: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
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.
Outcome measures
| Measure |
IDegAsp OD
n=265 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=261 Participants
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes
|
19 Episodes/100 years of patient exposure
|
53 Episodes/100 years of patient exposure
|
PRIMARY outcome
Timeframe: Week 0 to Week 53 + 7 days follow upPopulation: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild:no or transient symptoms, no interference with the subject's daily activities. Moderate: marked symptoms, moderate interference with the subject's daily activities. Severe: considerable interference with the 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 hospitalisation/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect
Outcome measures
| Measure |
IDegAsp OD
n=265 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=261 Participants
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Adverse events (AE)
|
313 Events/100 years of patient exposure
|
238 Events/100 years of patient exposure
|
|
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Serious AE
|
17 Events/100 years of patient exposure
|
9 Events/100 years of patient exposure
|
|
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Severe AE
|
9 Events/100 years of patient exposure
|
10 Events/100 years of patient exposure
|
|
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Moderate AE
|
77 Events/100 years of patient exposure
|
66 Events/100 years of patient exposure
|
|
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Mild AE
|
227 Events/100 years of patient exposure
|
162 Events/100 years of patient exposure
|
|
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)
Fatal AE
|
2 Events/100 years of patient exposure
|
1 Events/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week 0, Week 53Population: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed.
Change from baseline in HbA1c after 52 weeks of treatment.
Outcome measures
| Measure |
IDegAsp OD
n=266 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=263 Participants
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment
|
-1.39 percentage of glycosylated haemoglobin
Standard Deviation 1.23
|
-1.34 percentage of glycosylated haemoglobin
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: Week 26Population: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). One subject was excluded from FAS because the subject was randomised in error and was not dosed. For 24 subjects all 9-point SMPG values were missing.
Mean of SMPG at 26 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.
Outcome measures
| Measure |
IDegAsp OD
n=256 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=249 Participants
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26
|
7.9 mmol/L
Standard Deviation 2.1
|
7.9 mmol/L
Standard Deviation 1.7
|
Adverse Events
IDegAsp OD
Serious events: 30 serious events
Other events: 88 other events
Deaths: 0 deaths
IGlar OD
Serious events: 15 serious events
Other events: 79 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegAsp OD
n=265 participants at risk
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=261 participants at risk
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.75%
2/265 • Number of events 2 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Coronary artery disease
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Ileus paralytic
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
General disorders
Death
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
General disorders
Non-cardiac chest pain
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Bronchitis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Gastroenteritis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Osteomyelitis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Injury, poisoning and procedural complications
Skull fracture
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hypoglycaemic unconsciousness
|
0.75%
2/265 • Number of events 2 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Cerebrovascular insufficiency
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Dizziness
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Haemorrhagic stroke
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal inflammation
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Thrombophlebitis
|
0.38%
1/265 • Number of events 3 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Thrombosis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Hypertension
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Reproductive system and breast disorders
Endometrial hyperplasia
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Brain oedema
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Sepsis
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Necrotising fasciitis
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Cellulitis
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.75%
2/265 • Number of events 2 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Dental caries
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Eye disorders
Cataract
|
0.00%
0/265 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.38%
1/261 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Myocardial infarction
|
0.75%
2/265 • Number of events 2 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.38%
1/265 • Number of events 1 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.00%
0/261 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
Other adverse events
| Measure |
IDegAsp OD
n=265 participants at risk
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously (s.c.) once daily (OD) in combination with subject's pre-trial treatment of metformin. IDegAsp was given with breakfast for 26 weeks in the main period and with either breakfast or with the largest meal for another 26 weeks in the extension period.
|
IGlar OD
n=261 participants at risk
Insulin glargine (IGlar) was given subcutaneously (s.c.) once daily (OD) according to approved labelling in combination with subject's pre-trial treatment of metformin. IGlar was given for 52 weeks (26 weeks in main period and 26 weeks in extension period).
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
13.6%
36/265 • Number of events 47 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
13.4%
35/261 • Number of events 51 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Nervous system disorders
Headache
|
6.0%
16/265 • Number of events 19 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
4.2%
11/261 • Number of events 20 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Vascular disorders
Hypertension
|
7.5%
20/265 • Number of events 23 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
4.2%
11/261 • Number of events 12 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
6.0%
16/265 • Number of events 24 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
4.2%
11/261 • Number of events 15 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
5.7%
15/265 • Number of events 17 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
4.6%
12/261 • Number of events 18 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Infections and infestations
Bronchitis
|
5.3%
14/265 • Number of events 15 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
3.8%
10/261 • Number of events 11 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.9%
13/265 • Number of events 20 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
5.7%
15/261 • Number of events 16 • Week 0 to Week 53 + 7 days follow up.
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER