Comparison of NN1250 Plus Insulin Aspart With Insulin Det... | NCT01074268

NCT01074268

Secondary IDs

ID	Type	Description
2009-011672-29	EudraCT Number
U1111-1111-7249	Other Identifier	WHO
JapicCTI-101067	Registry Identifier	JAPIC
2009-015721-36	EudraCT Number
U1111-1114-9479	Other Identifier	WHO
JapicCTI-22-0677	Registry Identifier	JAPIC

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
IDeg OD	Experimental		Drug: insulin degludec Drug: insulin aspart
IDet	Active Comparator		Drug: insulin detemir Drug: insulin aspart

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Injected s.c. (under the skin) 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 26 Weeks of Treatment	Change from baseline in HbA1c after 26 weeks of treatment	Week 0, Week 26
Extension Trial (Primary Endpoint): Rate of Treatment Emergent Adverse Events (AEs)	Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/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 or important medical issues	Week 0 to Week 52 + 7 days follow up

Secondary Outcomes

Measure	Description	Time Frame
Extension Trial (Secondary 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
Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Eligibility Module

Contacts/Locations 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		Caba		C1440AAD	Argentina
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24702700	Result	Davies MJ, Gross JL, Ono Y, Sasaki T, Bantwal G, Gall MA, Niemeyer M, Seino H; BEGIN BB T1 Study Group. Efficacy and safety of insulin degludec given as part of basal-bolus treatment with mealtime insulin aspart in type 1 diabetes: a 26-week randomized, open-label, treat-to-target non-inferiority trial. Diabetes Obes Metab. 2014 Oct;16(10):922-30. doi: 10.1111/dom.12298. Epub 2014 May 8.
26435472

Label	URL
Clinical Trials at Novo Nordisk	View source

IPD Sharing Statement Module

No data available

No data is available for this block.

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
FG001	IDet OD

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

FG000303 subjects
FG001153 subjects

Type of Units Analyzed

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
BG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 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
	BG00041.1± 14.9 BG00141.7± 14.4 BG00241.3± 14.7

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000152 BG00167 BG002

Glycosylated haemoglobin (HbA1c)

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0008.0± 1.0 BG0018.0± 0.9 BG002

Fasting plasma glucose (FPG)

Mean

Standard Deviation

mmol/L

Title

Denominators

Categories

Title	Measurements
	BG0009.9± 4.0 BG0019.5± 4.0 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 26 Weeks of Treatment

Change from baseline in HbA1c after 26 weeks of treatment

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

Posted

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Week 0, Week 26

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Units	Counts
Participants	OG000302 OG001153

Title

Denominators

Categories

Title	Measurements
	OG000-0.73± 0.88 OG001-0.65± 0.86

Secondary

Extension Trial (Secondary Endpoint): Change in Glycosylated Haemoglobin (HbA1c) After 52 Weeks of Treatment

Change from baseline in HbA1c after 52 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 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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Units	Counts
Participants

Secondary

Main Trial (Secondary Endpoint): Mean of 9-point Self Measured Plasma Glucose Profile (SMPG) at Week 26

Mean of 9-point self-measured plasma glucose profile (SMPG) after week 26. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.

The FAS included all randomised subjects and missing data was imputed using LOCF. For 5 subjects, all 9-point SMPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 26

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Secondary

Extension 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) at week 52. Plasma glucose was measured before breakfast, 90 minutes after the start of breakfast, before lunch, 90 minutes after the start of lunch, before main evening meal, 90 minutes after the start of main evening meal, before bedtime, at 04:00 AM and before breakfast on the following day.

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 4 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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Secondary

Main Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 26 Weeks of Treatment

Change from baseline in FPG after 26 weeks of treatment

The FAS included all randomised subjects and missing data was imputed using LOCF. For 6 subjects change in FPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

Week 0, Week 26

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Units	Counts
Participants

Secondary

Extension Trial (Secondary Endpoint): Change in Fasting Plasma Glucose (FPG) After 52 Weeks of Treatment

Change from baseline in FPG after 52 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. For 6 subjects change in FPG values were missing.

Posted

Mean

Standard Deviation

mmol/L

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Units	Counts
Participants

Secondary

Main Trial (Secondary 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: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where the subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms.

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 26 + 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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Secondary

Main Trial (Secondary 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: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

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 26 + 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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Secondary

Extension 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 in the main trial including subjects carried through to the extension trial.

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Secondary

Extension Trial (Secondary 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: episodes requiring active assistance of another person to administer carbohydrate, glucagon, or other resuscitative actions. Minor hypoglycaemic episodes: episodes where subject was able to treat her/himself and plasma glucose below 3.1 mmol/L, with or without symptoms. Nocturnal hypoglycaemic episodes are defined as occuring between 00:01 and 05:59 a.m.

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 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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

Primary

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

Rate of AEs per 100 patient years of exposure. Severity assessed by investigator. Mild: no/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 or important medical issues

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

Events/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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.
OG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.

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 OD was given for 26 weeks in the main period and for another 26 weeks in the extension period.			36	301	185	301
EG001	IDet OD	Insulin detemir (IDet) was given subcutaneously (s.c.) once daily (OD) in the evening or twice daily (BID) morning and evening in combination with insulin aspart (IAsp) as meal-time insulin. IDet was given for 26 weeks in the main period and for another 26 weeks in the extension period.			11	152	89	152

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Hyperthyroidism	Endocrine disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0011 events1 affected152 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Abscess oral	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Cellulitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Pyelonephritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Fractured ischium	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Heat stroke	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Subdural haematoma	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Wrong drug administered	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Exocrine pancreatic function test abn	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected152 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0002 events2 affected301 at risk EG0011 events1 affected152 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected152 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00016 events12 affected301 at risk EG0018 events5 affected152 at risk
Hypoglycaemic unconsciousness	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0009 events9 affected301 at risk EG0016 events5 affected152 at risk
Ketosis	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Grand mal convulsion	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0004 events4 affected301 at risk EG0011 events1 affected152 at risk
Petit mal epilepsy	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected152 at risk
Swelling face	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected301 at risk EG0012 events2 affected152 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Hypoglycaemia unawareness	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 events0 affected301 at risk EG0011 events1 affected152 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Cerebral infarction	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 events1 affected301 at risk EG0010 events0 affected152 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG000162 events94 affected301 at risk EG00179 events49 affected152 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00061 events34 affected301 at risk EG00128 events17 affected152 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG00025 events15 affected301 at risk EG00113 events11 affected152 at risk
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG00084 events42 affected301 at risk EG00125 events12 affected152 at risk
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG00023 events21 affected301 at risk EG00112 events8 affected152 at risk
Diabetic retinopathy	Eye disorders	MedDRA 14.0	Systematic Assessment	EG00022 events20 affected301 at risk EG0017 events7 affected152 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG00025 events20 affected301 at risk EG00110 events9 affected152 at risk
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG00024 events16 affected301 at risk EG00110 events9 affected152 at risk
Gastroenteritis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00023 events22 affected301 at risk EG00111 events10 affected152 at risk
Influenza	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG00014 events14 affected301 at risk EG00110 events9 affected152 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG00024 events21 affected301 at risk EG0015 events5 affected152 at risk

ID	Term
D003920	Diabetes Mellitus
D003922	Diabetes Mellitus, Type 1

Ancestor Terms

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
C571886	insulin degludec
D000069057	Insulin Detemir
D061267	Insulin Aspart

Ancestor Terms

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

Units	Counts
Participants	OG000301 OG001150

Units	Counts
Participants	OG000301 OG001152