A Trial Comparing the Safety and Efficacy of Insulin Degl... | NCT02034513

ID	Type	Description	Link
U1111-1129-9668	Other Identifier	WHO
2012-001930-32	EudraCT Number

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IDeg OD + IAsp followed by IGlar OD + IAsp	Experimental	Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period	Drug: insulin degludec Drug: insulin glargine Drug: insulin aspart
IGlar OD + IAsp followed by IDeg OD + IAsp	Active Comparator	Each treatment period consists of a 16-week wash-out period and a 16-week maintenance period	Drug: insulin degludec Drug: insulin glargine Drug: insulin aspart

Interventions

Name	Type	Description	Arm Group Labels	Other Names
insulin degludec	Drug	Administered once daily, injected s.c. / subcutaneously (under the skin). Dose is individually adjusted.	IDeg OD + IAsp followed by IGlar OD + IAsp

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Treatment Emergent Severe or BG (Blood Glucose) Confirmed Symptomatic Hypoglycaemic Episodes During the Maintenance Period	Severe or blood glucose (BG) confirmed symptomatic hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment. Maintenance period: 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64).	A 16-week treatment period.

Secondary Outcomes

Measure	Description	Time Frame
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period	Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.

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	35215-7502	United States
Novo Nordisk Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28672316	Result	Lane W, Bailey TS, Gerety G, Gumprecht J, Philis-Tsimikas A, Hansen CT, Nielsen TSS, Warren M; Group Information; SWITCH 1. Effect of Insulin Degludec vs Insulin Glargine U100 on Hypoglycemia in Patients With Type 1 Diabetes: The SWITCH 1 Randomized Clinical Trial. JAMA. 2017 Jul 4;318(1):33-44. doi: 10.1001/jama.2017.7115.
30097995

Label	URL
Clinical Trials at Novo Nordisk	View source

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Insulin Degludec/Insulin Glargine (IDeg/IGlar)	Subjects received insulin degludec (IDeg) in treatment period 1 and insulin glargine (IGlar) in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered subcutaneously (s.c.; under the skin) in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken once daily (OD) at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast self measured plasma glucose(SMPG) values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L)

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Arm/Group Information

ID	Title	Description
BG000	Insulin Degludec/Insulin Glargine (IDeg/IGlar)	Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
BG001	Insulin Glargine/Insulin Degludec (IGlar/IDeg)	Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
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
	OG0002772 OG0013126

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001	Statistical analysis was performed on the FAS. Number of subjects analysed=subjects in the FAS, who were exposed in at least one maintenance period. Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Number of treatment-emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period.	Poisson		<0.0001		Treatment ratio	0.89			2-Sided	95	0.85	0.94			If non-inferiority was confirmed the superiority of IDeg/IGlar was investigated outside of the test hierarchy. Superiority was considered confirmed if the upper bound of the 2-sided 95% confidence interval was <1.00.

Secondary

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episodes During the Maintenance Period

Severe or BG confirmed symptomatic nocturnal hypoglycaemic episodes were defined as episodes that were severe and/or BG confirmed by a plasma glucose value of <3.1 mmol/L (56 mg/dL), with symptoms consistent with hypoglycaemia and with time of onset between 00:01 and 05.59 a.m., both inclusive. Treatment emergent hypoglycaemic episode was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.

The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.

Posted

Number

Event

After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

ID	Title	Description
OG000	Insulin Degludec (IDeg)	Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).

Secondary

Proportion of Subjects With One or More Severe Hypoglycaemic Episodes During the Maintenance Period

Percentage of subjects who experienced one or more severe hypoglycaemic episodes during the maintenance period. Severe hypoglycaemia (according to the American Diabetes Association 2013 definition): A hypoglycaemic episode requiring assistance of another person to actively administer carbohydrate, glucagon, or take other corrective actions. Plasma glucose values may not be available during an event, but neurological recovery following the return of plasma glucose to normal is considered sufficient evidence that the event was induced by a low plasma glucose concentration.

The trial followed a cross over design. Descriptive analysis was based on the SAS. Number of subjects analysed=subjects in the SAS, who were exposed in at least one maintenance period.

Posted

Number

Percentage of subjects

After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

ID	Title	Description
OG000	Insulin Degludec (IDeg)	Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).

Secondary

Incidence of Treatment Emergent Adverse Events

Treatment emergent adverse event was defined as an event with onset date on or after the first day of exposure to randomised treatment and no later than the last day of randomised treatment.

The trial followed a cross over design. Results are based on the SAS.

Posted

Number

Event

During 32 weeks of treatment for each treatment period

ID	Title	Description
OG000	Insulin Degludec (IDeg)	Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).
OG001	Insulin Glargine (IGlar)	Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).

Secondary

Change From Baseline in HbA1c (Glycosylated Haemoglobin)

Change from baseline in HbA1c (glycosylated haemoglobin) at week 32 (treatment period 1) and at week 64 (treatment period 2). Week 32 HbA1c absolute value was considered as baseline for calculating change from baseline in HbA1c at week 64.

Both descriptive analysis and statistical analysis were based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.

Posted

Mean

Standard Deviation

Percentage of glycosylated haemoglobin

Week 32, Week 64

ID	Title	Description
OG000	Insulin Degludec/Insulin Glargine (IDeg/IGlar)	Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
OG001	Insulin Glargine/Insulin Degludec (IGlar/IDeg)

Secondary

FPG (Fasting Plasma Glucose)

Fasting plasma glucose values at week 32 and week 64.

Results are based on the FAS. Here, 'n' specifies the number of subjects with available data at specified time-point.

Posted

Mean

Standard Deviation

mmol/L

Week 32 and Week 64

ID	Title	Description
OG000	Insulin Degludec/Insulin Glargine (IDeg/IGlar)	Subjects received IDeg in treatment period 1 and IGlar in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg and IGlar were administered s.c.in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg and IGlar were reduced by 20% at the start of both the treatment periods. Doses of IDeg and IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration fasting glycaemic target of 4.0-5.0 mmol/L).
OG001	Insulin Glargine/Insulin Degludec (IGlar/IDeg)	Subjects received IGlar in treatment period 1 and IDeg in treatment period 2. Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar and IDeg were administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and were to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar and IDeg were reduced by 20% at the start of both the treatment periods. Doses of IGlar and IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).

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	Insulin Degludec (IDeg)	Subjects received IDeg in treatment period 1 (from treatment sequence IDeg/IGlar) and in treatment period 2 (from treatment sequence IGlar/IDeg). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IDeg was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IDeg were reduced by 20% at the start of both the treatment periods. Doses of IDeg were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).			58	454	97	454
EG001	Insulin Glargine (IGlar)	Subjects received IGlar in treatment period 1 (from treatment sequence IGlar/IDeg) and in treatment period 2 (from treatment sequence IDeg/IGlar). Each treatment period consisted of a 16-week titration period and a 16-week maintenance period (total 32 weeks for each treatment period). IGlar was administered s.c. in the morning (from waking up to breakfast) or in the evening (from main evening meal to bedtime), as per randomisation and was to be taken OD at the same time of day throughout the trial. To prevent an increased risk of hypoglycaemia in the first treatment month, the overall daily doses of IGlar were reduced by 20% at the start of both the treatment periods. Doses of IGlar were titrated individually. Titration of the dose was performed once weekly based on the lowest of 3 pre-breakfast SMPG values measured on 3 consecutive days immediately prior to titration (fasting glycaemic target of 4.0-5.0 mmol/L).			70	460	97	460

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Accidental overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected454 at risk EG0013 events3 affected460 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0011 events1 affected460 at risk
Ascites	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Bacterial sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Biliary dyskinesia	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Breast cancer in situ	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Calculus ureteric	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0003 events2 affected454 at risk EG0010 events0 affected460 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Colitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Constipation	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0004 events2 affected454 at risk EG0013 events3 affected460 at risk
Dizziness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected454 at risk EG0010 events0 affected460 at risk
Fungal skin infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Gun shot wound	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Haematoma	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Headache	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG00032 events17 affected454 at risk EG00147 events33 affected460 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Hypoglycaemic seizure	Nervous system disorders	MedDRA	Systematic Assessment	EG0005 events3 affected454 at risk EG0015 events5 affected460 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG00023 events18 affected454 at risk EG00124 events19 affected460 at risk
Ileus	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0011 events1 affected460 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Intervertebral disc displacement	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Loss of consciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Multiple sclerosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Optic neuritis	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0011 events1 affected460 at risk
Overdose	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Pancreas transplant	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Papillary thyroid cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Pelvic fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected454 at risk EG0013 events3 affected460 at risk
Pneumonia bacterial	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Pneumothorax	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Pyrexia	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Respiratory fume inhalation disorder	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Schizophrenia	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected454 at risk EG0010 events0 affected460 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0010 events0 affected460 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected454 at risk EG0012 events2 affected460 at risk
Wolff-Parkinson-White syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected454 at risk EG0011 events1 affected460 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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment		EG00092 events68 affected454 at risk EG00173 events61 affected460 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment		EG00034 events29 affected454 at risk EG00141 events39 affected460 at risk

ID	Term
C571886	insulin degludec
D000069036	Insulin Glargine
D061267	Insulin Aspart