Comparison of NN1250 Plus Insulin Aspart With Insulin Gla... | NCT00982228

ID	Type	Description
2008-005774-13	EudraCT Number
U1111-1111-8789	Other Identifier	WHO
2009-015755-24	EudraCT Number
U1111-1116-1578	Other Identifier	WHO

Status Module

Oversight Module

Description Module

Label	Type	Description	Intervention Names
IDeg OD	Experimental		Drug: insulin degludec Drug: insulin aspart
IGlar OD	Active Comparator		Drug: insulin glargine Drug: insulin aspart

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected subcutaneously once daily. Dose was individually adjusted.	IDeg OD

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment	Change from baseline in HbA1c after 52 weeks of treatment	Week 0, Week 52
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)	Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.	Week 0 to Week 104 + 7 days follow up
Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes	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.	Week 0 to Week 104 + 7 days follow up
Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin	The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.	Week 0, Week 106

Secondary Outcomes

Measure	Description	Time Frame
Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes	Rate of confirmed hypoglycaemic episodes per 100 patient years of exposure (PYE). Confirmed hypoglycaemic episodes consisted of severe hypoglycaemia as well as minor hypoglycaemic episodes. Severe hypoglycaemic episodes are defined as requiring assistance to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes are defined as able to treat her/himself and plasma glucose below 3.1 mmol/L. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

Eligibility Module

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Birmingham	Alabama	35209	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23130654	Result	Ratner RE, Gough SC, Mathieu C, Del Prato S, Bode B, Mersebach H, Endahl L, Zinman B. Hypoglycaemia risk with insulin degludec compared with insulin glargine in type 2 and type 1 diabetes: a pre-planned meta-analysis of phase 3 trials. Diabetes Obes Metab. 2013 Feb;15(2):175-84. doi: 10.1111/dom.12032. Epub 2012 Dec 3.
26484727	Result

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
FG001	IGlar OD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
BG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

years

Title

Denominators

Categories

Title	Measurements
	BG00042.8± 13.7 BG00143.7± 13.3 BG00243.0± 13.6

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000194 BG00167 BG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0007.7± 0.9 BG0017.7± 1.0 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.1± 4.0 BG0019.7± 4.4 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Main Trial (Primary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 weeks of treatment

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

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 52

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Units	Counts
Participants	OG000472 OG001157

Title

Denominators

Categories

Title	Measurements
	OG000-0.40± 0.73 OG001-0.39± 0.84

Primary

Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)

Corresponds to rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no or transient symptoms, no interference with subject's daily activities. Moderate: marked symptoms, moderate interference with subject's daily activities. Severe: considerable interference with subject's daily activities, unacceptable. Serious AE: AE that at any dose results in any of the following: death, a life-threatening experience, in-subject hospitalization/prolongation of existing hospitalisation, persistent/significant disability/incapacity/congenital anomaly/birth defect.

Safety analysis set (SAS) included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.

Posted

Number

Events/100 years of patient exposure

Week 0 to Week 104 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Primary

Extension Trial (Primary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

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.

The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 104 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Secondary

Extension Trial (Primary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 104 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Primary

Extension Trial (Primary Endpoint): Cross-reacting Antibodies to Human Insulin

The unit for measuring antibody levels is amount of tracer bound to the antibodies in the precipitate (B) expressed in percentage of the total amount of tracer (T) added to the mixture (%B/T). Samples were taken before 1st dosing and after a 1-week wash-out period.

The SAS included all subjects who received at least one dose of the investigational product or its comparator in the main trial including subjects carried through to the extension trial.

Posted

Mean

Standard Deviation

%B/T

Week 0, Week 106

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Units	Counts

Secondary

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 104 Weeks of Treatment

Change from baseline in HbA1c after 104 weeks of treatment

The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF.

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 104

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Units	Counts
Participants

Secondary

Extension Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 104 of Treatment

Mean of 9-point self-measured plasma glucose profile (SMPG) after 104 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

The FAS included all randomised subjects in the main trial including subjects carried through to the extension trial and missing data was imputed using LOCF. For 12 subjects all 9-point SMPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Treatment week 104

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Rate of Confirmed Hypoglycaemic Episodes

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 52 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Rate of Nocturnal Confirmed Hypoglycaemic Episodes

The SAS included all subjects who received at least one dose of the investigational product or its comparator.

Posted

Number

Episodes/100 years of patient exposure

Week 0 to Week 52 + 7 days follow up

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 52

Mean of 9-point self-measured plasma glucose profile (SMPG) after 52 weeks of treatment. Plasma glucose measured: before breakfast, 90 minutes after start of breakfast, before lunch, 90 minutes after start of lunch, before dinner, 90 minutes after start of dinner, bedtime, at 4 am and before breakfast.

The FAS included all randomised subjects and missing data was imputed using LOCF. For 7 subjects all 9-point SMPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 52

ID	Title	Description
OG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.
OG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.

Units	Counts

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	IDeg OD	Insulin degludec (IDeg) was given subcutaneously (s.c.) once daily (OD) in the evening in combination with insulin aspart (IAsp) as meal time insulin. IDeg was given for 52 weeks in the main period and for an additional 52 weeks in the extension period.			71	472	353	472
EG001	IGlar OD	Insulin glargine (IGlar) was given s.c. once daily (OD) according to approved labelling in combination with insulin aspart (IAsp) as meal time insulin. IGlar was given for 52 weeks in the main period and for additional 52 weeks in the extension period.			29	154	118	154

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute myocardial infarction	Cardiac disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Myocardial infarction	Cardiac disorders	MedDRA (Unknown)	Systematic Assessment	EG0002 events2 affected472 at risk EG0011 events1 affected154 at risk
Colitis	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Gastritis	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Melaena	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Sudden death	General disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0011 events1 affected154 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Cellulitis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Cholecystitis infective	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Gastroenteritis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Pneumonia	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0011 events1 affected154 at risk
Pulmonary tuberculoma	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Pulmonary tuberculosis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Forearm fracture	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Incorrect dose administered	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0002 events2 affected472 at risk EG0010 events0 affected154 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Pneumothorax traumatic	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA (Unknown)	Systematic Assessment	EG0002 events2 affected472 at risk EG0013 events3 affected154 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (Unknown)	Systematic Assessment	EG00038 events27 affected472 at risk EG00110 events7 affected154 at risk
Hypoglycaemic seizure	Metabolism and nutrition disorders	MedDRA (Unknown)	Systematic Assessment	EG0003 events3 affected472 at risk EG0012 events2 affected154 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA (Unknown)	Systematic Assessment	EG00020 events15 affected472 at risk EG0014 events4 affected154 at risk
Arthritis reactive	Musculoskeletal and connective tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Bone pain	Musculoskeletal and connective tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Tenosynovitis	Musculoskeletal and connective tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Convulsion	Nervous system disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Cervical dysplasia	Reproductive system and breast disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Bundle branch block left	Cardiac disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Coronary artery disease	Cardiac disorders	MedDRA (Unknown)	Systematic Assessment	EG0002 events2 affected472 at risk EG0010 events0 affected154 at risk
Pericarditis	Cardiac disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Ventricular arrhythmia	Cardiac disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Ventricular Tachycardia	Cardiac disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Tympanic membrane perforation	Ear and labyrinth disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Pancreatic pseudocyst	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Allergy to animal	Immune system disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Appendicitis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0011 events1 affected154 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Accidental Overdose	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Injury	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Tendon Rupture	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Neck pain	Musculoskeletal and connective tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Osteonecrosis	Musculoskeletal and connective tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Gallbladder cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Glioblastoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Oesophageal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Headache	Nervous system disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Hypoglycaemic encephalopathy	Nervous system disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Syncope	Nervous system disorders	MedDRA (Unknown)	Systematic Assessment	EG0001 events1 affected472 at risk EG0010 events0 affected154 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk
Renal failure acute	Renal and urinary disorders	MedDRA (Unknown)	Systematic Assessment	EG0000 events0 affected472 at risk EG0011 events1 affected154 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Diarrhoea	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG00044 events39 affected472 at risk EG00112 events9 affected154 at risk
Nausea	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG00057 events40 affected472 at risk EG00118 events14 affected154 at risk
Vomiting	Gastrointestinal disorders	MedDRA (Unknown)	Systematic Assessment	EG00026 events25 affected472 at risk EG00115 events11 affected154 at risk
Bronchitis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG00046 events38 affected472 at risk EG00117 events11 affected154 at risk
Gastroenteritis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG00049 events44 affected472 at risk EG00110 events9 affected154 at risk
Influenza	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG00053 events44 affected472 at risk EG00119 events17 affected154 at risk
Nasopharyngitis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG000284 events160 affected472 at risk EG001105 events51 affected154 at risk
Sinusitis	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG00093 events58 affected472 at risk EG00131 events23 affected154 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG000208 events122 affected472 at risk EG00148 events31 affected154 at risk
Urinary tract infection	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG00040 events35 affected472 at risk EG00116 events12 affected154 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA (Unknown)	Systematic Assessment	EG00035 events31 affected472 at risk EG0016 events6 affected154 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA (Unknown)	Systematic Assessment	EG00070 events44 affected472 at risk EG00118 events13 affected154 at risk
Headache	Nervous system disorders	MedDRA (Unknown)	Systematic Assessment	EG000162 events84 affected472 at risk EG00139 events22 affected154 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA (Unknown)	Systematic Assessment	EG00037 events33 affected472 at risk EG00119 events17 affected154 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA (Unknown)	Systematic Assessment	EG00046 events34 affected472 at risk EG00119 events14 affected154 at risk
Seasonal allergy	Immune system disorders	MedDRA (Unknown)	Systematic Assessment	EG00011 events10 affected472 at risk EG00110 events10 affected154 at risk
Gastrointestinal viral	Infections and infestations	MedDRA (Unknown)	Systematic Assessment	EG00027 events25 affected472 at risk EG0019 events6 affected154 at risk
Back Pain	Musculoskeletal and connective tissue disorders	MedDRA (Unknown)	Systematic Assessment	EG00046 events33 affected472 at risk EG00115 events9 affected154 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unknown)	Systematic Assessment	EG00018 events17 affected472 at risk EG00113 events11 affected154 at risk
Sinus congestion	Respiratory, thoracic and mediastinal disorders	MedDRA (Unknown)	Systematic Assessment	EG00025 events22 affected472 at risk EG00112 events9 affected154 at risk

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases
D001327	Autoimmune Diseases
D007154	Immune System Diseases

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins
D061266	Insulin, Short-Acting

ID	Term
C571886	insulin degludec
D000069036	Insulin Glargine
D061267	Insulin Aspart