Trial Outcomes & Findings for Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes (NCT NCT01009580)
NCT ID: NCT01009580
Last Updated: 2018-12-19
Results Overview
Change from baseline in HbA1c after 26 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
447 participants
Primary outcome timeframe
Week 0, Week 26
Results posted on
2018-12-19
Participant Flow
The trial was conducted at 50 sites in 10 countries: Australia (5 sites), Denmark (7 sites), Finland (5 sites), India (9 sites), Malaysia (3 sites), Poland (5 sites), Sweden (6 sites), Taiwan (3 sites), Thailand (3 sites), Turkey (4 sites). In addition, 1 site in Thailand screened but did not randomise any subjects.
Between screening and randomisation, eligible subjects were to continue their usual pre-trial oral anti-diabetic drug (OAD) of metformin, pioglitazone and DPP-4 inhibitor.
Participant milestones
| Measure |
IDegAsp BID
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
Overall Study
STARTED
|
224
|
223
|
|
Overall Study
Exposed
|
224
|
222
|
|
Overall Study
COMPLETED
|
197
|
188
|
|
Overall Study
NOT COMPLETED
|
27
|
35
|
Reasons for withdrawal
| Measure |
IDegAsp BID
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
Overall Study
Adverse Event
|
4
|
4
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
|
Overall Study
Protocol Violation
|
2
|
3
|
|
Overall Study
Withdrawal Criteria
|
4
|
6
|
|
Overall Study
Unclassified
|
17
|
21
|
Baseline Characteristics
Comparison of NN5401 With Biphasic Insulin Aspart 30 in Type 2 Diabetes
Baseline characteristics by cohort
| Measure |
IDegAsp BID
n=224 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
n=222 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
Total
n=446 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.7 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
58.8 years
STANDARD_DEVIATION 9.8 • n=4 Participants
|
58.7 years
STANDARD_DEVIATION 9.8 • n=27 Participants
|
|
Sex: Female, Male
Female
|
95 Participants
n=93 Participants
|
103 Participants
n=4 Participants
|
198 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=93 Participants
|
119 Participants
n=4 Participants
|
248 Participants
n=27 Participants
|
|
Glycosylated haemoglobin (HbA1c)
|
8.3 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=93 Participants
|
8.4 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.9 • n=4 Participants
|
8.4 percentage of glycosylated haemoglobin
STANDARD_DEVIATION 0.8 • n=27 Participants
|
|
Fasting plasma glucose (FPG)
|
8.9 mmol/L
STANDARD_DEVIATION 2.9 • n=93 Participants
|
8.6 mmol/L
STANDARD_DEVIATION 2.6 • n=4 Participants
|
8.7 mmol/L
STANDARD_DEVIATION 2.8 • n=27 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 randomised in error, hence removed from the FAS.
Change from baseline in HbA1c after 26 weeks of treatment.
Outcome measures
| Measure |
IDegAsp BID
n=224 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
n=222 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
Change in Glycosylated Haemoglobin (HbA1c)
|
-1.28 percentage of glycosylated haemoglobin
Standard Deviation 0.94
|
-1.30 percentage of glycosylated haemoglobin
Standard Deviation 0.97
|
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 randomised in error, hence removed from the FAS. For 24 subjects all 9-point SMPG values were missing.
Mean of SMPG after 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 BID
n=211 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
n=211 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG)
|
7.0 mmol/L
Standard Deviation 1.6
|
7.3 mmol/L
Standard Deviation 2.1
|
SECONDARY outcome
Timeframe: Week 0 to Week 26 + 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L.
Outcome measures
| Measure |
IDegAsp BID
n=224 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
n=222 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
Rate of Confirmed Hypoglycaemic Episodes
|
972 Episodes/100 years of patient exposure
|
1396 Episodes/100 years of patient exposure
|
SECONDARY outcome
Timeframe: Week 0 to Week 26 + 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 were defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes were defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes were defined as occurring between 00:01 and 05:59 a.m.
Outcome measures
| Measure |
IDegAsp BID
n=224 Participants
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
n=222 Participants
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
Rate of Nocturnal Confirmed Hypoglycaemic Episodes
|
74 Episodes/100 years of patient exposure
|
253 Episodes/100 years of patient exposure
|
Adverse Events
IDegAsp BID
Serious events: 19 serious events
Other events: 60 other events
Deaths: 0 deaths
BIAsp 30 BID
Serious events: 36 serious events
Other events: 52 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IDegAsp BID
n=224 participants at risk
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
n=222 participants at risk
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Angina pectoris
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Angina unstable
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Arrhythmia supraventricular
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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 asthma
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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 stenosis
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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 ischaemia
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Diabetic retinopathy
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.90%
2/222 • Number of events 2 • The adverse events were collected in a time frame of 26 weeks + 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 perforation
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Gastritis
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Chest pain
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Pyrexia
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.90%
2/222 • Number of events 2 • The adverse events were collected in a time frame of 26 weeks + 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
Malaria
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Pulmonary tuberculosis
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Tooth abscess
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Vestibular neuronitis
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Alcohol poisoning
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Fall
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Head injury
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Incorrect dose administered
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Radius fracture
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Snake bite
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Upper limb fracture
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.89%
2/224 • Number of events 3 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
2.7%
6/222 • Number of events 6 • The adverse events were collected in a time frame of 26 weeks + 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
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
2.3%
5/222 • Number of events 5 • The adverse events were collected in a time frame of 26 weeks + 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
Pain in extremity
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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)
Adenocarcinoma
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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)
Uterine leiomyoma
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Carpal tunnel syndrome
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Cerebral infarction
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Cervicobrachial syndrome
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Adenomyosis
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Breast mass
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Asthma
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Chronic obstructive pulmonary disease
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Dyspnoea
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Epistaxis
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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
Interstitial lung disease
|
0.45%
1/224 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Intermittent claudication
|
0.00%
0/224 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
0.45%
1/222 • Number of events 1 • The adverse events were collected in a time frame of 26 weeks + 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 BID
n=224 participants at risk
Insulin degludec/insulin aspart (IDegAsp) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. IDegAsp was given with the breakfast meal and main evening meal.
|
BIAsp 30 BID
n=222 participants at risk
Biphasic insulin aspart 30 (BIAsp 30) was given subcutaneously twice daily (BID) with or without Metformin, DPP-4 inhibitor, Pioglitazone. BIAsp 30 was given with the breakfast meal and main evening meal.
|
|---|---|---|
|
General disorders
Pyrexia
|
5.8%
13/224 • Number of events 15 • The adverse events were collected in a time frame of 26 weeks + 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%
0/222 • The adverse events were collected in a time frame of 26 weeks + 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
Nasopharyngitis
|
11.6%
26/224 • Number of events 28 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
9.5%
21/222 • Number of events 28 • The adverse events were collected in a time frame of 26 weeks + 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
|
7.6%
17/224 • Number of events 19 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
7.7%
17/222 • Number of events 18 • The adverse events were collected in a time frame of 26 weeks + 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
|
5.8%
13/224 • Number of events 16 • The adverse events were collected in a time frame of 26 weeks + 7 days follow up
The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.
|
8.1%
18/222 • Number of events 22 • The adverse events were collected in a time frame of 26 weeks + 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