A Trial Comparing the Safety and Efficacy of Insulin Degl... | NCT02030600

ID	Type	Description	Link
U1111-1143-7963	Other Identifier	WHO

Status Module

Oversight Module

Description 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 ± OADs followed by IGlar OD ± OADs	Experimental	The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.	Drug: insulin degludec Drug: insulin glargine
IGlar OD ± OADs followed by IDeg OD ± OADs	Active Comparator	The trial includes two 32-week treatment periods in a cross-over design. Total trial duration for the individual subjects will be up to 67 weeks.	Drug: insulin degludec Drug: insulin glargine

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 ± OADs followed by IGlar OD ± OADs

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Treatment Emergent Severe or BG 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 <56 mg/dL (3.1 mmol/L), 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.	After 16 weeks of treatment, in each treatment period (Week 16-32 and Week 48-64)

Secondary Outcomes

Measure	Description	Time Frame
Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode 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 <56 mg/dL (3.1 mmol/L), 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
30705500	Background	Chaykin L, Bhargava A, de la Rosa R, Wysham CH, Norgard Troelsen L, Ostoft SH, Philis-Tsimikas A. Effect of Insulin Degludec Versus Insulin Glargine U100 on Hypoglycemia in Hispanic Patients With Type 2 Diabetes: Results From the SWITCH 2 Trial. Clin Diabetes. 2019 Jan;37(1):73-81. doi: 10.2337/cd18-0016.
28672317	Result

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 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 at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting self-measured plasma glucose (SMPG) values on 3 consecutive days (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 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 at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (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 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 at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (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
	BG00061.5± 10.7 BG00161.2± 10.3 BG00261.4± 10.5

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000169 BG001169 BG002

Glycosylated haemoglobin

Mean

Standard Deviation

percentage of glycosylated haemoglobin

Title

Denominators

Categories

Title	Measurements
	BG0007.6± 1.1 BG0017.6± 1.1 BG002

Fasting plasma glucose

Number of subjects analyzed=355 for IDeg/IGlar arm, 358 for IGlar/IDeg arm and 713 for total.

Mean

Standard Deviation

mg/dL

Title

Denominators

Categories

Title	Measurements
	BG000139.2± 53.5 BG001134.9± 51.6

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

Number of Treatment Emergent Severe or BG 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 <56 mg/dL (3.1 mmol/L), 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.

The trial followed a cross over design. Descriptive analysis was based on the safety analysis set (subjects receiving at least one dose of the investigational product or its comparator). Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on full analysis set

Posted

Number

events

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

ID	Title	Description
OG000	Insulin Degludec (IDeg)	Subjects receiving 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 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 at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
OG001	Insulin Glargine (IGlar)	Subjects receiving 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 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 at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).

Units	Counts
Participants	OG000632 OG001618

Title

Denominators

Categories

Title	Measurements
	OG000353 OG001496

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	Stepwise hierarchical testing procedure was applied for confirmatory endpoints: Step 1: Primary analysis: Number of treatment emergent severe or BG confirmed symptomatic hypoglycaemic episodes during the maintenance period	Poisson		<0.0001		Treatment ratio	0.70			2-Sided	95	0.61	0.80			Superiority was considered confirmed if the 95% confidence interval for the rate ratio (IDeg/IGlar) was entirely below 1.0.		Superiority or Other

Secondary

Number of Treatment Emergent Severe or BG Confirmed Symptomatic Nocturnal Hypoglycaemic Episode 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 <56 mg/dL (3.1 mmol/L), 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.

Posted

Number

events

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

ID	Title	Description
OG000	Insulin Degludec (IDeg)	Subjects receiving 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 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 at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (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 safety analysis set. Number of subjects analysed=subjects with available data for the endpoint as per individual trial products. Statistical analysis was performed on subjects in full analysis set with exposure in both maintenance periods.

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 receiving 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 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 at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (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.

Safety analysis set included all subjects receiving at least one dose of the investigational product or its comparator (Total number of subjects analysed for this endpoint: 713).

Posted

Number

events

During 32 weeks of treatment for each treatment period

ID	Title	Description
OG000	Insulin Degludec (IDeg)	Subjects receiving 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 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 at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).
OG001	Insulin Glargine (IGlar)

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 value was considered as baseline for calculating change from baseline in HbA1c at week 64.

Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.

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 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 at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (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.

Full analysis set. Here, 'n' specifies the number of subjects with available data at specified timepoint.

Posted

Mean

Standard Deviation

mg/dL

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 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 at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Doses of IDeg and IGlar were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (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 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 at the same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total insulin daily dose was recommended. Doses of IGlar and IDeg were titrated individually. Adjustment of the dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (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 receiving 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 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 at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IDeg was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).			64	671	93	671
EG001	Insulin Glargine (IGlar)	Subjects receiving 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 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 at same time of day throughout the trial. Subjects receiving pre-trial once daily basal insulin were to continue on their pre-trial basal insulin dose. For subjects receiving pre-trial twice daily basal insulin, a 20% reduction of the total daily insulin dose was recommended. Dose of IGlar was titrated individually. Adjustment of dose was performed once weekly based on the mean of 3 preceding daily fasting SMPG values on 3 consecutive days (fasting glycaemic target of 4.0-5.0 mmol/L).			65	665	77	665

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abnormal behaviour	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Acute coronary syndrome	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0011 events1 affected665 at risk
Angina pectoris	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0014 events4 affected665 at risk
Angina unstable	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0012 events2 affected665 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Anxiety	Psychiatric disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Aortic aneurysm	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Aortic stenosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Aphasia	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Appendicitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Arthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0010 events0 affected665 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0012 events2 affected665 at risk
Atrial fibrillation	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Bipolar I disorder	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Brain neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Breast cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Bronchitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Bronchopulmonary aspergillosis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Calculus bladder	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Cardiac failure	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0012 events2 affected665 at risk
Carpal tunnel decompression	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Cellulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Cellulitis staphylococcal	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0011 events1 affected665 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Chest discomfort	General disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Chest pain	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Colitis ischaemic	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Colon cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Computerised tomogram thorax abnormal	Investigations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Confusion postoperative	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Confusional state	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Coronary artery disease	Cardiac disorders	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0013 events3 affected665 at risk
Coronary artery dissection	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Cystitis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Deep vein thrombosis	Vascular disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0011 events1 affected665 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Diverticular fistula	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Diverticulitis	Infections and infestations	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0010 events0 affected665 at risk
Drug dispensing error	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0002 events1 affected671 at risk EG0010 events0 affected665 at risk
Electrolyte imbalance	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Fall	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0011 events1 affected665 at risk
Fibromyalgia	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Flatulence	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Gastroenteritis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0011 events1 affected665 at risk
Hepatic cyst	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0019 events9 affected665 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Impaired gastric emptying	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Influenza	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Iridocyclitis	Eye disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Ischaemic stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Jaundice cholestatic	Hepatobiliary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Lacunar stroke	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Lead dislodgement	General disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Lumbar vertebral fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Lung adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Mastoiditis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Medication error	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Mental status changes	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Metastases to bone	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Mitral valve repair	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Myocardial infarction	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0011 events1 affected665 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Non-cardiac chest pain	General disorders	MedDRA	Systematic Assessment	EG0003 events3 affected671 at risk EG0013 events3 affected665 at risk
Ophthalmic herpes zoster	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0011 events1 affected665 at risk
Osteomyelitis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Otitis externa	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Ovarian mass	Reproductive system and breast disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0010 events0 affected665 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Panic attack	Psychiatric disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Pituitary tumour benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Pneumonia	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Post lumbar puncture syndrome	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events1 affected671 at risk EG0010 events0 affected665 at risk
Postoperative wound infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Prostatic operation	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Renal cyst	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0012 events2 affected665 at risk
Renal failure	Renal and urinary disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0011 events1 affected665 at risk
Salmonella sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0014 events4 affected665 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Squamous cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Sternal fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Surgery	Surgical and medical procedures	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Syncope	Nervous system disorders	MedDRA	Systematic Assessment	EG0002 events2 affected671 at risk EG0011 events1 affected665 at risk
Thalamic infarction	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Toxic encephalopathy	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0012 events2 affected665 at risk
Urinary tract infection	Infections and infestations	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Vertebral artery thrombosis	Nervous system disorders	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk
Vomiting	Gastrointestinal disorders	MedDRA	Systematic Assessment	EG0000 events0 affected671 at risk EG0011 events1 affected665 at risk
Wrist fracture	Injury, poisoning and procedural complications	MedDRA	Systematic Assessment	EG0001 events1 affected671 at risk EG0010 events0 affected665 at risk

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine 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

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
Nasopharyngitis	Infections and infestations	MedDRA	Systematic Assessment		EG00059 events50 affected671 at risk EG00149 events41 affected665 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA	Systematic Assessment		EG00053 events44 affected671 at risk EG00144 events37 affected665 at risk