Trial Outcomes & Findings for A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes (NCT NCT01059812)

NCT ID: NCT01059812

Last Updated: 2018-12-20

Results Overview

Change from baseline in HbA1c after 26 weeks of treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

424 participants

Primary outcome timeframe

Week 0, Week 26

Results posted on

2018-12-20

Participant Flow

The trial was conducted at 45 sites in 5 countries: Japan (16 sites), South Korea (16 sites), Hong Kong (1 site), Malaysia (8 sites) and Taiwan (4 sites).

Participant milestones

Participant milestones
Measure	IDegAsp BID Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Overall Study STARTED	282	142
Overall Study Exposed	279	141
Overall Study COMPLETED	245	126
Overall Study NOT COMPLETED	37	16

Reasons for withdrawal

Reasons for withdrawal
Measure	IDegAsp BID Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Overall Study Adverse Event	9	5
Overall Study Lack of Efficacy	2	2
Overall Study Protocol Violation	3	1
Overall Study Withdrawal Criteria	9	4
Overall Study Unclassified	14	4

Baseline Characteristics

A Pan Asian Trial Comparing Efficacy and Safety of NN5401 and Biphasic Insulin Aspart 30 in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	IDegAsp BID n=280 Participants Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=142 Participants Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.	Total n=422 Participants Total of all reporting groups
Age, Continuous	59.1 years STANDARD_DEVIATION 10.2 • n=93 Participants	61.2 years STANDARD_DEVIATION 9.5 • n=4 Participants	59.8 years STANDARD_DEVIATION 10.0 • n=27 Participants
Sex: Female, Male Female	129 Participants n=93 Participants	63 Participants n=4 Participants	192 Participants n=27 Participants
Sex: Female, Male Male	151 Participants n=93 Participants	79 Participants n=4 Participants	230 Participants n=27 Participants
Glycosylated haemoglobin (HbA1c)	8.4 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)	7.9 mmol/L STANDARD_DEVIATION 2.5 • n=93 Participants	7.9 mmol/L STANDARD_DEVIATION 2.5 • n=4 Participants	7.9 mmol/L STANDARD_DEVIATION 2.5 • n=27 Participants
Body weight at randomisation	66.1 kg STANDARD_DEVIATION 11.2 • n=93 Participants	66.0 kg STANDARD_DEVIATION 11.2 • n=4 Participants	66.0 kg STANDARD_DEVIATION 11.2 • n=27 Participants

PRIMARY outcome

Timeframe: Week 0, Week 26

Population: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF).

Change from baseline in HbA1c after 26 weeks of treatment.

Outcome measures

Outcome measures
Measure	IDegAsp BID n=280 Participants Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=142 Participants Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Change in HbA1c (Glycosylated Haemoglobin) After 26 Weeks of Treatment	-1.38 percentage of glycosylated haemoglobin Standard Deviation 0.88	-1.42 percentage of glycosylated haemoglobin Standard Deviation 0.97

SECONDARY outcome

Timeframe: Week 26

Population: The full analysis set (FAS) included all randomised subjects and missing data were imputed using last observation carried forward (LOCF). 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

Outcome measures
Measure	IDegAsp BID n=265 Participants Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=133 Participants Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26	7.6 mmol/L Standard Deviation 1.7	7.9 mmol/L Standard Deviation 1.8

SECONDARY outcome

Timeframe: Week 0 to Week 26 + 7 days follow up

Population: 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.

Outcome measures

Outcome measures
Measure	IDegAsp BID n=279 Participants Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=141 Participants Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Rate of Confirmed Hypoglycaemic Episodes	956 Episodes/100 years of patient exposure	952 Episodes/100 years of patient exposure

SECONDARY outcome

Timeframe: Week 0 to Week 26 + 7 days follow up

Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Outcome measures

Outcome measures
Measure	IDegAsp BID n=279 Participants Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=141 Participants Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Rate of Nocturnal Confirmed Hypoglycaemic Episodes	111 Episodes/100 years of patient exposure	155 Episodes/100 years of patient exposure

SECONDARY outcome

Timeframe: Week 0, Week 26

Population: The safety analysis set included all subjects who received at least one dose of the investigational product or its comparator.

Change from baseline in body weight after 26 weeks of treatment.

Outcome measures

Outcome measures
Measure	IDegAsp BID n=279 Participants Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=141 Participants Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Change in Body Weight	1.1 kg Standard Deviation 2.9	1.4 kg Standard Deviation 3.0

Adverse Events

IDegAsp BID

Serious events: 23 serious events

Other events: 84 other events

Deaths: 0 deaths

BIAsp 30 BID

Serious events: 12 serious events

Other events: 39 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	IDegAsp BID n=279 participants at risk Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=141 participants at risk Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Eye disorders Diabetic retinopathy	6.8% 19/279 • 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.	6.4% 9/141 • Number of events 9 • 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	18.3% 51/279 • Number of events 58 • 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.	13.5% 19/141 • Number of events 26 • 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	7.5% 21/279 • Number of events 24 • 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.	8.5% 12/141 • Number of events 20 • 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

Public Access to Clinical Trials

Novo Nordisk A/S

Email: [email protected]

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

Measure	IDegAsp BID n=279 participants at risk Insulin degludec/insulin aspart (IDegAsp) was given twice daily (BID) with breakfast and evening meal with or without metformin.	BIAsp 30 BID n=141 participants at risk Biphasic insulin aspart (BIAsp 30) was given twice daily (BID) with breakfast and evening meal with or without metformin.
Cardiac disorders Acute coronary syndrome	0.00% 0/279 • 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.	0.71% 1/141 • 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 Acute myocardial infarction	0.00% 0/279 • 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.	1.4% 2/141 • 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.
Cardiac disorders Angina pectoris	0.00% 0/279 • 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.	0.71% 1/141 • 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	0.36% 1/279 • 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% 0/141 • 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	0.36% 1/279 • 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% 0/141 • 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	0.36% 1/279 • 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% 0/141 • 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	0.36% 1/279 • 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% 0/141 • 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 Glaucoma	0.00% 0/279 • 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.	0.71% 1/141 • 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.
Gastrointestinal disorders Intestinal obstruction	0.36% 1/279 • 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% 0/141 • 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 Pancreatitis chronic	0.36% 1/279 • 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% 0/141 • 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	0.36% 1/279 • 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.	0.71% 1/141 • 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 Cholecystitis acute	0.00% 0/279 • 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.	0.71% 1/141 • 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 Cellulitis	0.36% 1/279 • 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% 0/141 • 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	0.72% 2/279 • 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.	0.00% 0/141 • 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 Pneumonia	0.36% 1/279 • 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% 0/141 • 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 Subcutaneous abscess	0.36% 1/279 • 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% 0/141 • 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 Urinary tract infection	0.00% 0/279 • 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.	0.71% 1/141 • 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 Clavicle fracture	0.36% 1/279 • 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% 0/141 • 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 Drug toxicity	0.00% 0/279 • 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.	0.71% 1/141 • 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% 0/279 • 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.	0.71% 1/141 • 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 Femur fracture	0.00% 0/279 • 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.	0.71% 1/141 • 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 Joint sprain	0.36% 1/279 • 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% 0/141 • 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 Diabetic foot	0.36% 1/279 • 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% 0/141 • 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	0.36% 1/279 • 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.	0.00% 0/141 • 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	0.72% 2/279 • 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.	0.71% 1/141 • 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.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.36% 1/279 • 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% 0/141 • 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 Trigger finger	0.36% 1/279 • 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% 0/141 • 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) Breast cancer	0.36% 1/279 • 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% 0/141 • 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) Metastatic gastric cancer	0.00% 0/279 • 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.	0.71% 1/141 • 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 Carotid artery occlusion	0.36% 1/279 • 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% 0/141 • 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 Dysarthria	0.00% 0/279 • 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.	0.71% 1/141 • 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 Ischaemic stroke	0.00% 0/279 • 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.	0.71% 1/141 • 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.
Psychiatric disorders Suicide attempt	0.36% 1/279 • 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% 0/141 • 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.
Renal and urinary disorders Nephrolithiasis	0.00% 0/279 • 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.	0.71% 1/141 • 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 Acute pulmonary oedema	0.00% 0/279 • 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.	0.71% 1/141 • 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	0.36% 1/279 • 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% 0/141 • 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 Emphysema	0.36% 1/279 • 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% 0/141 • 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	0.36% 1/279 • 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% 0/141 • 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.