A Trial Comparing the Efficacy and Safety of Insulin Degl... | NCT03078478

ID	Type	Description	Link
U1111-1184-8175	Other Identifier	WHO
2016-002801-20	EudraCT Number

Label	Type	Description	Intervention Names
IDeg 200 U/mL	Experimental		Drug: Insulin degludec
IGlar 300 U/mL	Active Comparator		Drug: Insulin glargine

Name	Type	Description	Arm Group Labels	Other Names
Insulin degludec	Drug	For subcutaneous (s.c., under the skin) injection once daily	IDeg 200 U/mL

Measure	Description	Time Frame
Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)	Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.	36 Weeks

Measure	Description	Time Frame
Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)	The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks).	88 weeks
Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Anniston	Alabama	36207	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
30974986	Background	Philis-Tsimikas A, Stratton I, Norgard Troelsen L, Anker Bak B, Leiter LA. Efficacy and Safety of Degludec Compared to Glargine 300 Units/mL in Insulin-Experienced Patients With Type 2 Diabetes: Trial Protocol Amendment (NCT03078478). J Diabetes Sci Technol. 2019 May;13(3):498-506. doi: 10.1177/1932296819841585. Epub 2019 Apr 11.
31984443

ID	Title	Description
FG000	Insulin Degludec U200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 29, 2019	Jan 28, 2020

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 Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks) period. Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Posted

Number

Episodes/(PYE*100)

36 Weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Units	Counts
Participants	OG000742 OG001741

Title

Denominators

Categories

Title	Measurements
	OG000216.8 OG001243.9

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	The number of episodes is analysed using a negative binomial regression model (log link) with the logarithm of the time period in which a hypoglycaemic episode was considered treatment emergent as offset. The model includes treatment, number of OADs, region, sex and dosing time as fixed factors, and age as a covariate. Missing values are imputed through multiple imputation by treatment arm, based on a Poisson model.	Regression, Cox		0.1715		Treatment rate ratio	0.88			2-Sided	95	0.73	1.06					Superiority

Secondary

Basal Insulin Dose (U) at End of Treatment (up to 88 Weeks)

The observed mean daily basal insulin doses was evaluated at the end of trial (88 weeks).

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

Posted

Mean

Standard Deviation

Units

88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated during maintenance 2 (36 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

Posted

Number

Episodes/(PYE*100)

36 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Number of Severe Hypoglycaemic Episodes During Maintenance 2 (36 Weeks)

Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for maintenance 2 period. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

Posted

Number

Episodes/(PYE*100)

36 weeks (maintenance 2)

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Change in HbA1c From Baseline to End of Treatment (up to 88 Weeks)

Change in glycosylated haemoglobin (HbA1c) was evaluated from baseline to end of treatment period (week 88).

The full analysis set (FAS) comprised all randomised subjects. Number Analyzed = number of participants with available data.

Posted

Mean

Standard Deviation

Percentage of HbA1c

Week 0, week 88

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Change in Fasting Plasma Glucose (FPG) From Baseline to End of Treatment (up to 88 Weeks)

Change in fasting plasma glucose (FPG) was evaluated from baseline to end of treatment period (week 88).

Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Posted

Mean

Standard Deviation

mg/dL

Week 0, week 88

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Percentage of Participants With FPG ≤ 7.2 mmol/L (130 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)

Participants achieving a fasting plasma glucose value of less than or equal to 7.2 mmol/L (130 mg/dL) at end of treatment (up to 88 weeks).

Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Posted

Number

Percentage of participants

At 88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Percentage of Participants With FPG ≤ 5.0 mmol/L (90 mg/dL) at End of Treatment (up to 88 Weeks) (Yes/no)

Participants achieving a fasting plasma glucose value of less than or equal to 5.0 mmol/L (90 mg/dL) at end of treatment (up to 88 weeks).

Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Posted

Number

Percentage of participants

At 88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Severe or BG Confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)

Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).

Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Posted

Number

Percentage of participants

End of Treatment (up to 88 Weeks)

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Percentage of Participants With HbA1c < 7.0% (53 mmol/Mol) at End of Treatment (up to 88 Weeks) and no Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Maintenance 2 (36 Weeks) (Yes/no)

Participants achieving target HbA1c of less than 7.0% at the end of treatment (88 weeks) without nocturnal severe or BG-confirmed hypoglycaemia during maintenance 2 (36 weeks).

Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Posted

Number

Percentage of participants

At 88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Change in Mean Pre-breakfast Self-measured Plasma Glucose Used for Titration From Baseline to End of Treatment (up to 88 Weeks)

Participants measured their pre-breakfast self-measured plasma glucose (SMPG) value until end of treatment (week 88). Mean pre-breakfast self-measured plasma glucose used for titration at baseline and end of treatment (up to 88 weeks) are presented.

Full analysis set (FAS) included all randomised subjects. Number Analyzed = number of participants with available data.

Posted

Mean

Standard Deviation

mmol/L

Week 0, week 88

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Number of Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)

Severe or BG confirmed symptomatic hypoglycaemia was evaluated during treatment (up to 88 weeks). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Posted

Number

Episodes/(PYE*100)

88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300

Secondary

Number of Nocturnal, Severe or BG-confirmed Symptomatic Hypoglycaemic Episodes During Treatment (up to 88 Weeks)

Nocturnal severe or BG confirmed symptomatic hypoglycaemia was evaluated at the end of trial (88 weeks). The nocturnal period defined as the period between 00:01 and 05:59 a.m. (both inclusive). Severe or BG confirmed symptomatic hypoglycaemia: An episode that is severe according to the ADA 2013 classification or blood glucose (BG) confirmed by a plasma glucose value <3.1 mmol/L (56 mg/dL) with symptoms consistent with hypoglycaemia. The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe or BG-confirmed symptomatic hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Posted

Number

Episodes/(PYE*100)

88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001

Secondary

Number of Severe Hypoglycaemic Episodes During Treatment (up to 88 Weeks)

Severe hypoglycaemia are those episodes positively adjudicated by the event adjudication committee according to the ADA definition of a severe hypoglycaemic episode. This was evaluated for the total trial period (88 weeks). The observed rates (number of episodes divided by patient years of exposure multiplied by 100) of severe hypoglycaemic episodes per patient years of exposure (PYE) is presented in this endpoint results.

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Posted

Number

Episodes/(PYE*100)

88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Secondary

Number of Adverse Events From Randomisation to End of Maintenance Period 2 (up to 88 Weeks)

The adverse events presented are treatment emergent. A treatment-emergent AE (TEAE) was defined as an event that had onset date on or after the first day of exposure to randomised treatment and no later than 7 days after the last days of randomised treatment or had onset date before the first day of exposure on randomised treatment and increased in severity during the treatment period and until 7 days after the last date of randomised treatment. Number of adverse events expressed in rates, from randomisation to end of maintenance period 2 (up to 88 weeks) is presented. Rate = number of events divided by patient years of exposure multiplied by 100.

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator.

Posted

Number

Episodes/(PYE*100)

88 weeks

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001

Secondary

Change in Body Weight From Baseline to End of Treatment (up to 88 Weeks)

Change in body weight, measured in kilograms, from baseline (week 0) to end of treatment (week 88).

The safety analysis set (SAS) comprised all subjects who received at least one dose of the investigational product or comparator. Number Analyzed = number of participants with available data.

Posted

Mean

Standard Deviation

Week 0, week 88

ID	Title	Description
OG000	Insulin Degludec 200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
OG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal pain	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Abdominal pain upper	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Abdominal wall operation	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Abscess limb	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Acetabulum fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Acute interstitial pneumonitis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0004 events4 affected802 at risk EG0019 events8 affected798 at risk
Acute left ventricular failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected802 at risk EG0012 events2 affected798 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0012 events2 affected798 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Alcohol withdrawal syndrome	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0014 events4 affected798 at risk
Anaphylactic reaction	Immune system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Angina pectoris	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0012 events2 affected798 at risk
Angina unstable	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0007 events6 affected802 at risk EG0014 events4 affected798 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Aortic valve stenosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Appendicitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Appendicitis perforated	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Arterial bypass occlusion	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Asthenia	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Ataxia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0009 events9 affected802 at risk EG0015 events5 affected798 at risk
Atrial flutter	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Atrial tachycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Atrioventricular block second degree	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Bladder prolapse	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Bladder transitional cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Bladder transitional cell carcinoma stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Blindness unilateral	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Blood lactic acid increased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Bradycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0012 events2 affected798 at risk
Breast cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Bronchitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0011 events1 affected798 at risk
Bronchitis bacterial	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Bundle branch block left	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Bundle branch block right	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Capsular contracture associated with breast implant	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Cardiac ablation	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Cardiac arrest	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Cardiac failure	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0012 events2 affected798 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0006 events6 affected802 at risk EG0013 events3 affected798 at risk
Cardiac pacemaker insertion	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Cardio-respiratory arrest	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Cardiogenic shock	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Cardiomyopathy	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0003 events2 affected802 at risk EG0010 events0 affected798 at risk
Carotid artery disease	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Carotid artery occlusion	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Cartilage injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Cellulitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0013 events3 affected798 at risk
Cerebral infarction	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Cerebrovascular disorder	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Cervical radiculopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Cervical spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Cervical vertebral fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Chest discomfort	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Chest pain	General disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Cholecystitis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0016 events4 affected798 at risk
Chronic tonsillitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Cirrhosis alcoholic	Hepatobiliary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Colon adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Colorectal adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Confusional state	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Coronary artery disease	Cardiac disorders	MedDRA 21	Systematic Assessment	EG00010 events10 affected802 at risk EG0015 events5 affected798 at risk
Coronary artery occlusion	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0011 events1 affected798 at risk
Craniocerebral injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0012 events2 affected798 at risk
Dehydration	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected802 at risk EG0010 events0 affected798 at risk
Delirium	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Dementia Alzheimer's type	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Depression	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Diabetes mellitus	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Diabetic foot	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Diabetic foot infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0010 events0 affected798 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Diabetic retinopathy	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Diffuse large B-cell lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Diverticulitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0014 events3 affected798 at risk
Diverticulum	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Diverticulum intestinal haemorrhagic	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Dizziness	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Drug administered in wrong device	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Duodenal ulcer haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Dysarthria	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Embolic stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Embolism venous	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Emphysema	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Endocarditis staphylococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Enteritis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Epistaxis	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Erythema	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Escherichia urinary tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Eye haematoma	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Faecaloma	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0013 events3 affected798 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Gait disturbance	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Gangrene	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Gastric bypass	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Gastritis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Gastritis erosive	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0010 events0 affected798 at risk
Gastroenteritis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Gastroenteritis viral	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Gastroenterostomy	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Gastrointestinal angiodysplasia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected802 at risk EG0011 events1 affected798 at risk
Gastrointestinal procedural complication	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Gastrooesophageal reflux disease	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Goitre	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Haematemesis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Haematochezia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Haematoma	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Haemoglobin decreased	Investigations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Haemorrhagic stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Headache	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Helicobacter infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Hepatic cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hepatitis A	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hepatitis C	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hepatocellular carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hiatus hernia	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hidradenitis	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Hyperammonaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events1 affected798 at risk
Hyperglycaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hypertension	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Hypertensive crisis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Hypertensive emergency	Vascular disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Hypertensive heart disease	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Hypoaesthesia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0008 events8 affected802 at risk EG00121 events19 affected798 at risk
Hypoglycaemic coma	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0004 events3 affected802 at risk EG00111 events9 affected798 at risk
Hypokalaemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Hyponatraemia	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Hypotonia	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Hypoxia	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Ileus	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Incision site haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Influenza	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0011 events1 affected798 at risk
Intentional product misuse	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Internal haemorrhage	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Interstitial lung disease	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Intervertebral disc degeneration	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Intervertebral disc operation	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Intestinal obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Intracardiac thrombus	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Intraductal proliferative breast lesion	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0005 events5 affected802 at risk EG0014 events4 affected798 at risk
Jaw fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Joint abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Joint dislocation	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Joint injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Lacunar stroke	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Large intestinal polypectomy	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Leukocytosis	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Ligament rupture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Lipase increased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Localised infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Loss of consciousness	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Lower gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Lyme disease	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Macular degeneration	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0002 events1 affected802 at risk EG0010 events0 affected798 at risk
Malignant melanoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Medical device removal	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Metabolic acidosis	Metabolism and nutrition disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Metabolic encephalopathy	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Metabolic surgery	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Multiple drug therapy	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Multiple organ dysfunction syndrome	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Musculoskeletal chest pain	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Myocardial infarction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0014 events4 affected798 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Myofascial pain syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Neoplasm malignant	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0012 events2 affected798 at risk
Neuroendocrine carcinoma of the skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Neuropathic arthropathy	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Non-cardiac chest pain	General disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0012 events2 affected798 at risk
Oesophageal cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Oesophageal squamous cell carcinoma stage 0	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Orthostatic hypotension	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0015 events5 affected798 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Osteomyelitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events2 affected802 at risk EG0010 events0 affected798 at risk
Osteomyelitis acute	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Osteopenia	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Otitis externa	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Otitis media	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Pancreatic carcinoma stage IV	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Pancreatic duct dilatation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Pancreatitis	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Pancreatitis necrotising	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Parametritis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Peptic ulcer perforation	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Peripheral artery occlusion	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Peripheral artery stenosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Peripheral artery thrombosis	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Peripheral vascular disorder	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Peripheral venous disease	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Peritonitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Pleural effusion	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0002 events1 affected802 at risk EG0011 events1 affected798 at risk
Pneumonia	Infections and infestations	MedDRA 21	Systematic Assessment	EG0008 events6 affected802 at risk EG0019 events9 affected798 at risk
Pneumonia fungal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Polymyalgia rheumatica	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Polyuria	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Post procedural cellulitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Post procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Post procedural infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0012 events2 affected798 at risk
Post procedural oedema	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Post procedural pulmonary embolism	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Post-traumatic pain	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Postoperative respiratory failure	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Postoperative wound infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Presyncope	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Procedural hypertension	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Procedural nausea	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Prostate cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Prostate cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Pulmonary oedema	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Pyrexia	General disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Radiation oesophagitis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Rectal cancer stage I	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Rehabilitation therapy	Surgical and medical procedures	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Renal failure	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Renal mass	Renal and urinary disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Retinal detachment	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Retinal tear	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Retinopathy proliferative	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Rhabdomyolysis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Rhegmatogenous retinal detachment	Eye disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0012 events2 affected798 at risk
Rotator cuff syndrome	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Sarcoidosis	Immune system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Sciatica	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Seizure	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Sinus bradycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Sinus node dysfunction	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Sinus polyp	Respiratory, thoracic and mediastinal disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Sinus tachycardia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Squamous cell carcinoma of skin	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Staphylococcal sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Stasis dermatitis	Skin and subcutaneous tissue disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Steal syndrome	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Streptococcal sepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Subarachnoid haemorrhage	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Sudden death	General disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0011 events1 affected798 at risk
Syncope	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0012 events2 affected798 at risk
Thrombocytopenia	Blood and lymphatic system disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Thrombophlebitis superficial	Vascular disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Thyroid mass	Endocrine disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events2 affected798 at risk
Tooth abscess	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0012 events1 affected798 at risk
Toxicity to various agents	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0015 events5 affected798 at risk
Tuberculosis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Urinary tract infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0015 events5 affected798 at risk
Urosepsis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0002 events2 affected802 at risk EG0010 events0 affected798 at risk
Uterine prolapse	Reproductive system and breast disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Varicose vein	Vascular disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Vascular graft thrombosis	Injury, poisoning and procedural complications	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Ventricular hypokinesia	Cardiac disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Vertigo	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0003 events3 affected802 at risk EG0010 events0 affected798 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Vestibular neuronitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Viral infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Viral pharyngitis	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Vitello-intestinal duct remnant	Congenital, familial and genetic disorders	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Vitreous adhesions	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Vitreous haemorrhage	Eye disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0011 events1 affected798 at risk
Volvulus	Gastrointestinal disorders	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Weight decreased	Investigations	MedDRA 21	Systematic Assessment	EG0000 events0 affected802 at risk EG0011 events1 affected798 at risk
Wound infection	Infections and infestations	MedDRA 21	Systematic Assessment	EG0001 events1 affected802 at risk EG0010 events0 affected798 at risk
Wound infection staphylococcal	Infections and infestations	MedDRA 21	Systematic Assessment	EG0003 events1 affected802 at risk EG0010 events0 affected798 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

ID	Title	Description
BG000	Insulin Degludec U200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting self measured plasma glucose (SMPG) values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
BG001	Insulin Glargine U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.
BG002	Total	Total of all reporting 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 U200	Participants received insulin degludec 200 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± oral anti-diabetic drugs. The daily basal insulin dose was reduced by 20% from their pre-trial dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	7	802	167	802	496	802
EG001	IGlar U300	Participants received insulin glargine 300 units/mL once daily as subcutaneous injections (in the thigh, upper arm or abdomen) ± pre-trial oral anti-diabetic drugs. The dose of IGlar U300 corresponded to the pre-trial daily basal insulin dose. Insulin dose was adjusted once weekly by the investigator, based on the mean of three fasting SMPG values, to reach a SMPG of 4.0-5.0 mmol/L (71-90 mg/dL). The treatment duration was up to 88 weeks divided into; a 16-week titration period, an up to 36-week maintenance period 1 (variable length) and a 36-week maintenance period 2.	9	798	141	798	476	798