A Research Study to Compare the Effect of Insulin Deglude... | NCT03687827

ID	Type	Description	Link
U1111-1203-0580	Other Identifier	World Health Organization (WHO)
2017-004047-20	Registry Identifier	European Medicines Agency (EudraCT)

Label	Type	Description	Intervention Names
Insulin degludec	Experimental	Participants will receive insulin degludec in period 1 and 2 in a cross-over manner.	Drug: Insulin degludec
Insulin glargine	Active Comparator	Participants will receive insulin glargine in period 1 and 2 in a cross-over manner.	Drug: Insulin glargine

Name	Type	Description	Arm Group Labels	Other Names
Insulin degludec	Drug	Participants will receive insulin degludec U100 subcutaneous (s.c.) injection once daily for 36 weeks. Doses will be adjusted according to the fasting self-measured plasma glucose (SMPG) values. Participants earlier treated with one or more allowed oral antidiabetic drug(s) (OAD(s)), should continue their pre-trial OAD(s) treatment throughout the trial.

Measure	Description	Time Frame
Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)	The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter [mg/dL] (3.9-10.0 millimoles per litre [mmol/L]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis.	During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)

Measure	Description	Time Frame
Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring	The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35)).	During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female, age greater than or equal to 18 years at the time of signing informed consent
Diagnosed with type 2 diabetes mellitus greater than or equal to 180 days prior to the day of screening
Subjects fulfilling at least one of the below criteria:
Experienced at least one severe hypoglycaemic episode within the last year prior to screening (according to the American Diabetes Association definition, January 2018)*
Moderate renal impairment defined as estimated glomerular filtration rate value of 30-59 mL/min/1.73 m^2 as defined by Kidney Disease Improving Global Outcomes 2012 at screening
Known hypoglycaemic unawareness as indicated by the investigator according to Clarke's questionnaire question 8 at screening
Treated with insulin for more than 5 years
Episode of hypoglycaemia (defined a glucose alert value of 70 mg/dL (3.9 mmol/L) or less, i.e., Level 1) within the last 12 weeks prior to screening visit
Treated with any basal insulin greater than or equal to 90 days prior to the day of screening with or without any of the following anti-diabetic drugs:
Metformin
Dipeptidyl peptidase-4 inhibitor
Sodium-glucose co-transporter 2 inhibitor
Alpha-glucosidase-inhibitors (acarbose)
Thiazolidinediones
Marketed oral combination products only including the products listed above
HbA1c less than or equal to 9.5% (80 mmol/mol) at screening confirmed by central laboratory analysis
Body mass index less than or equal to 45 kg/m^2 *Hypoglycaemia associated with severe cognitive impairment requiring external assistance for recovery

Exclusion Criteria:

Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within the past 90 days prior to the day of screening. However, intermittent bolus insulin treatment for periods of no longer than 14 days are permitted prior to the day of screening
Anticipated initiation or change in concomitant medications known to affect weight or glucose metabolism (e.g., treatment with orlistat, thyroid hormones, or corticosteroids)
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a pharmacologically pupil-dilated fundus examination performed by an ophthalmologist or another suitably qualified health care provider within the past 90 days prior to screening or in the period between screening and run-in

Name	Affiliation	Role
Clinical Reporting Anchor and Disclosure (1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Chandler	Arizona	85224	United States
Novo Nordisk Investigational Site

PubMed Identifier	Type	Citation	Retractions
36905485	Derived	Goldenberg RM, Aroda VR, Billings LK, Donatsky AM, Frederiksen M, Klonoff DC, Kalyanam B, Bergenstal RM. Correlation Between Time in Range and HbA1c in People with Type 2 Diabetes on Basal Insulin: Post Hoc Analysis of the SWITCH PRO Study. Diabetes Ther. 2023 May;14(5):915-924. doi: 10.1007/s13300-023-01389-2. Epub 2023 Mar 11.
34322967

ID	Title	Description
FG000	Sequence A: Insulin Degludec 100U/mL Then Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of Insulin degludec 100U/mL (Units per milliliter) once daily (in treatment period 1), followed by a s.c. injection of Insulin glargine 100U/mL once daily (in treatment period 2) with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	May 4, 2020	Dec 16, 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

Percentage of Time Spent in Glycaemic Target Range 70-180 mg/dL (3.9-10.0 mmol/L) Both Inclusive, Using Flash Glucose Monitoring (FGM)

The percentage of time spent in glycaemic target range was calculated as the number of recorded measurements in glycaemic target range (70-180 milligrams per deciliter [mg/dL] (3.9-10.0 millimoles per litre [mmol/L]), both inclusive) divided by the total number of recorded measurements. The endpoint is based on data recorded by FGM system. It was required that at least 70% of the planned FGM measurements during weeks 16-17 and weeks 34-35 were available for endpoint data to be included in the analysis.

Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.

Complete FGM assessment was specified as subjects having at least 70% of 2 weeks FGM measurements per maintenance period (2 * 960 measurements).

Posted

Least Squares Mean

Standard Error

Percentage of Time

During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2)

ID	Title	Description
OG000	Insulin Degludec 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
OG001	Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

Units	Counts
Participants	OG000448 OG001448

Title

Denominators

Categories

Title	Measurements
	OG00072.11± 0.74 OG00170.68± 0.74

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		t-test, 2 sided		0.0321		Estimated treatment difference	1.43			2-Sided	95	0.12	2.74					Superiority	Superiority is confirmed if non-inferiority is confirmed and the lower limit of the two-sided 95% confidence interval is entirely above zero.
OG000 OG001

Secondary

Time Spent in Tight Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, Using Flash Glucose Monitoring

The percentage of time spent in tight glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, during the 2-week maintenance periods using FGM (visit 9-21 (week 16-17) and visit 37-39 (week 34-35)).

Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.

Posted

Least Squares Mean

Standard Error

Percentage of Time

During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

ID	Title	Description
OG000	Insulin Degludec 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
OG001	Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

Secondary

Time Spent in Nocturnal Glycaemic Target Range 70-140 mg/dL (3.9-7.8 mmol/L) Both Inclusive, in the Nocturnal Period (00:01 am - 05:59 am Both Inclusive) Using Flash Glucose Monitoring

Percentage of time spent in nocturnal glycaemic target range 70-140 mg/dL (3.9-7.8 mmol/L) both inclusive, in the nocturnal period (00:01 am - 05:59 am both inclusive) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).

Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.

Posted

Least Squares Mean

Standard Error

Percentage of Time

During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

ID	Title	Description
OG000	Insulin Degludec 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
OG001	Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

Secondary

Level of Glycated Haemoglobin (HbA1c) - Percentage

Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).

Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.

Posted

Least Squares Mean

Standard Error

Percentage of glycated haemoglobin

After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

ID	Title	Description
OG000	Insulin Degludec 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
OG001	Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

Secondary

Level of Glycated Haemoglobin (HbA1c) - mmol/Mol

Level of HbA1c after two weeks of maintenance periods (Visit 19-21 (week 16-17) and Visit 37-39 (week 34-35)).

Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.

Posted

Least Squares Mean

Standard Error

millimoles per mole (mmol/mol)

After the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

ID	Title	Description
OG000	Insulin Degludec 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
OG001	Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

Secondary

Mean Glucose Levels Using Flash Glucose Monitoring (FGM)

Mean glucose levels (mmol/L) during the 2-week maintenance periods using FGM (visit 19-21 (week 16-17) and visit 37-39 (week 34-35)).

Per protocol (PP) analysis set - The PP analysis set consisted of subjects that stayed on assigned treatment until and completed FGM assessment at visits 21 and 39 respectively.

Posted

Least Squares Mean

Standard Error

mmol/L

During the 2-week maintenance period: weeks 16-17 (period-1) and weeks 34-35 (period-2).

ID	Title	Description
OG000	Insulin Degludec 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.
OG001	Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0002 events2 affected490 at risk EG0010 events0 affected484 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Arteriovenous malformation	Congenital, familial and genetic disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Asthma	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0011 events1 affected484 at risk
Bradyarrhythmia	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Breast mass	Reproductive system and breast disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Bronchitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Cardiac failure	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0011 events1 affected484 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Carotid artery stenosis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Carpal tunnel syndrome	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Chronic obstructive pulmonary disease	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0002 events1 affected490 at risk EG0010 events0 affected484 at risk
Contusion	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Coronary arterial stent insertion	Surgical and medical procedures	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Diabetic gastroparesis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Duodenal ulcer	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Facial paralysis	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Gastritis	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Haematoma	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Hepatitis A	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Herpes zoster	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Hyperbilirubinaemia	Hepatobiliary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Hypoglycaemic unconsciousness	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Intercostal neuralgia	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Iron deficiency anaemia	Blood and lymphatic system disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Lacunar infarction	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Lower limb fracture	Injury, poisoning and procedural complications	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Migraine	Nervous system disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Mitral valve incompetence	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Myelodysplastic syndrome	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Myocardial infarction	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0011 events1 affected484 at risk
Non-Hodgkin's lymphoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Osteomyelitis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Osteomyelitis chronic	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Palpitations	Cardiac disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Pancreatic cyst	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0013 events1 affected484 at risk
Peripheral ischaemia	Vascular disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Pneumonia	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0003 events3 affected490 at risk EG0012 events2 affected484 at risk
Pseudomonas infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Rhinovirus infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Scan myocardial perfusion abnormal	Investigations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Sepsis	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Spinal osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Upper gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk
Urinary retention	Renal and urinary disorders	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Urinary tract infection	Infections and infestations	MedDRA 22.1	Systematic Assessment	EG0001 events1 affected490 at risk EG0010 events0 affected484 at risk
Vertebral foraminal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 22.1	Systematic Assessment	EG0000 events0 affected490 at risk EG0011 events1 affected484 at risk

ID	Term
D003920	Diabetes Mellitus
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	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Insulin Degludec 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin degludec 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.	0	490	26	490	0	490
EG001	Insulin Glargine 100U/mL	Participants were to receive a subcutaneous (s.c.) injection of insulin glargine 100U/mL, once daily, in any of the treatment period, with or without oral anti-diabetic drugs using flash glucose monitoring. Each treatment period consisted of a 16-week titration period followed by a 2-week maintenance period.	1	484	23	484	0	484