A Research Study to Compare a New Weekly Insulin, Insulin... | NCT04760626

NCT04760626

ID	Type	Description	Link
U1111-1247-5279	Other Identifier	World Health Organization (WHO)
2020-000476-38	EudraCT Number

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Insulin icodec with DoseGuide	Experimental	Participants randomised to insulin icodec will use insulin icodec with the DoseGuide App to guide their titration.	Drug: Insulin icodec
Once daily basal insulin analogues	Active Comparator	Participants randomised to basal insulin analogue injections once daily	Drug: Insulin Glargine 100U/mL Drug: Insulin Degludec Drug: Insulin Glargine 300U/mL

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Insulin icodec	Drug	Participants will receive subcutaneous (s.c.) injections of insulin icodec once weekly for 52 weeks.	Insulin icodec with DoseGuide

Outcomes Module

Measure	Description	Time Frame
Change in Glycated Haemoglobin (HbA1c)	Change in HbA1c from baseline (week 0) to week 52 is presented.	Baseline (week 0), week 52

Secondary Outcomes

Measure	Description	Time Frame
Time From Baseline to Treatment Discontinuation or Intensification	Time from baseline to treatment discontinuation or intensification from baseline (week 0) to week 52 is presented.	From baseline (week 0) to week 52
Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
Male or female.
Age above or equal to 18 years at the time of signing informed consent.
Diagnosed with T2D greater than or equal to 180 days prior to the day of screening.
HbA1c above 7.0% (53 mmol/mol) as measured by central lab.
Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
Stable daily dose(s) greater than or equal to 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regimen(s): a .Any metformin formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. b .Any metformin combination formulations greater than or equal to 1500 mg or maximum tolerated or effective dose. c. Any of the following non-insulin antidiabetic drug classes including combinations (greater than or equal to half of the maximum approved dose according to local label or maximum tolerated or effective dose):i). Sulfonylureas ii). Meglitinides (glinides) iii). DPP-4 inhibitors iv. SGLT2 inhibitors v). Thiazolidinediones vi). Alpha-glucosidase inhibitors vii). Oral combination products (for the allowed individual Oral Antidiabetic Drugs (OADs)) viii). Oral or injectable GLP-1-receptor agonists.
Intensification with insulin is indicated to achieve glycaemic target (4.4-7.2 mmol/L, 80-130 mg/dL) at the discretion of the treating investigator.

Exclusion Criteria:

Known or suspected hypersensitivity to trial product(s) or related products.
Previous participation in this trial. Participation is defined as signed informed consent.
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. (Simultaneous participation in a trial with the primary objective of evaluating an approved or non-approved investigational medicinal product for prevention or treatment of COVID-19 disease or postinfectious conditions is allowed if the last dose of the investigational medicinal product has been received more than 30 days before screening)
Any disorder which in the investigator's opinion might jeopardise subject's safety.

Contacts/Locations Module

Name	Affiliation	Role
Clinical Transparency (dept. 1452)	Novo Nordisk A/S	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Univ of Alabama Birmingham		Birmingham	Alabama	35233	United States
Lakeview Clinical Research, LLC

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
36106652	Result	Philis-Tsimikas A, Bajaj HS, Begtrup K, Cailleteau R, Gowda A, Lingvay I, Mathieu C, Russell-Jones D, Rosenstock J. Rationale and design of the phase 3a development programme (ONWARDS 1-6 trials) investigating once-weekly insulin icodec in diabetes. Diabetes Obes Metab. 2023 Feb;25(2):331-341. doi: 10.1111/dom.14871. Epub 2022 Oct 14.
40465144

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Nov 23, 2020	Aug 7, 2025

Derived Section

Miscellaneous Info Module

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

Intervention Browse Module

Masking Info

Full analysis set included all randomised participants.

Arm/Group Information

ID	Title	Description
BG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.
BG001	Once Daily Basal Insulin Analogue	Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Mean

Standard Deviation

Years

Title

Denominators

Categories

Title	Measurements
	BG00059.15± 10.79 BG00159.39± 10.15 BG00259.27± 10.47

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000233 BG001230 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00051 BG00144 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian Or Alaska Native	BG0002 BG0011 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Change in Glycated Haemoglobin (HbA1c)

Change in HbA1c from baseline (week 0) to week 52 is presented.

Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Least Squares Mean

Standard Error

Percentage of HbA1c

Baseline (week 0), week 52

ID	Title	Description
OG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.
OG001	Once Daily Basal Insulin Analogue	Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.

Units	Counts
Participants	OG000542 OG001542

Title

Denominators

Categories

Title	Measurements
	OG000-1.68± 0.09 OG001-1.31± 0.12

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 response and change from baseline in response after 52 weeks were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors, and baseline HbA1c as a covariate.	ANCOVA		<0.0001		Treatment difference	-0.38			2-Sided	95	-0.66	-0.09					Non-Inferiority	Non-inferiority of insulin icodec was considered confirmed if the upper limit of the two-sided 95% confidence interval (CI) for mean treatment difference (insulin icodec with doseguide minus once daily basal insulin analogue) was strictly below 0.3 percent point.

Secondary

Time From Baseline to Treatment Discontinuation or Intensification

Time from baseline to treatment discontinuation or intensification from baseline (week 0) to week 52 is presented.

FAS included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Median

Full Range

Weeks

From baseline (week 0) to week 52

ID	Title	Description
OG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.
OG001	Once Daily Basal Insulin Analogue	Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.

Secondary

Change in Diabetes Treatment Satisfaction Questionnaire (DTSQs) in Total Treatment Satisfaction

Change in DTSQs in total treatment satisfaction is presented. The DTSQs questionnaire was used to assess participants treatment satisfaction which contained 8 components (DTSQs Item 1-8 : how satisfied are you with your current treatment, how often have you felt that blood sugars have been unacceptably high, how often have you felt that blood sugars have been unacceptably low, how convenient have you been finding your treatment to be recently, how flexible have you been finding your treatment to be recently, how satisfied are you with your understanding of your diabetes, would you recommend treatment to someone else with your kind of diabetes, how satisfied would you be to continue with present form of treatment). The result presented is the treatment satisfaction summary score, which is the sum of 6 of the 8 items of the DTSQs questionnaire. Total scores for treatment satisfaction range from 0-36 with 0 being the lowest and 36 being the highest score in total treatment satisfaction.

Full analysis set included all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Least Squares Mean

Standard Error

Score on a scale

Baseline (week 0), week 52

ID	Title	Description
OG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.

Secondary

Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance Domain

Treatment Related Impact Measure for Diabetes (TRIM-D) Compliance domain at week 52 is presented. The TRIM-D questionnaire was developed to capture the impact of diabetes treatment on patients' functioning and well-being. The questionnaire was used to measure the compliance between the treatment groups. The total TRIM-D compliance score is computed by summing across the items and then transforming to a 0-100 scale with higher score indicating better compliance.

FAS included all randomised subjects.

Posted

Least Squares Mean

Standard Error

Score on a scale

At end of treatment (week 52)

ID	Title	Description
OG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.
OG001	Once Daily Basal Insulin Analogue	Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.

Secondary

Number of Severe Hypoglycaemic Episodes (Level 3)

Number of severe hypoglycaemic episodes (level 3) is presented. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.

Safety analysis set included all participants who were randomly assigned to trial treatment and who took at least 1 dose of trial product. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Number

Episodes

From baseline (week 0) to week 57

ID	Title	Description
OG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.
OG001	Once Daily Basal Insulin Analogue	Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.

Secondary

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 Millimoles Per Liter [mmol/L] (54 Milligrams Per Deciliter [mg/dL]), Confirmed by Blood Glucose (BG) Meter)

Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 millimoles per liter [mmol/L] (54 mg/dL), confirmed by BG meter) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter.

Posted

Number

Episodes

From baseline (week 0) to week 57

ID	Title	Description
OG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.
OG001	Once Daily Basal Insulin Analogue

Secondary

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (Below 3.0 mmol/L (54 mg/dL), Confirmed by BG Meter) or Severe Hypoglycaemic Episodes (Level 3)

Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3) is presented. Clinically significant hypoglycaemia (level 2) is defined as plasma glucose value of less than (<) 3.0 mmol/L (54 mg/dL) confirmed by BG meter. Severe hypoglycaemia (level 3) is defined as hypoglycaemia with severe cognitive impairment requiring external assistance for recovery.

Posted

Number

Episodes

From baseline (week 0) to week 57

ID	Title	Description
OG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.
OG001

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Insulin Icodec	Participants were to receive once weekly subcutaneous (s.c.) injection of Insulin icodec guided by the DoseGuide app, for 52 weeks using PDS290 prefilled pen-injector. Participants were to perform once daily pre-breakfast self-monitoring plasma glucose (SMPG). The dose was adjusted based on 3 pre-breakfast SMPG values measured on the 2 previous days and the day of the contact. If at least one pre-breakfast SMPG value was: lesser than (<) 4.4 millimoles per liter (mmol/L): dose reduced by 20 units (U); 4.4-7.2 mmol/L: no adjustment; greater than (>) 7.2 mmol/L: dose increased by 20 U.	3	542	45	542	43	542
EG001	Once Daily Basal Insulin Analogue	Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.	6	543	57	538	55	538

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Acute coronary syndrome	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected542 at risk EG0010 events0 affected538 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0013 events3 affected538 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0004 events4 affected542 at risk EG0011 events1 affected538 at risk
Acute respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Adenocarcinoma pancreas	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Amnesia	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Anaemia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Angina pectoris	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0012 events2 affected538 at risk
Appendicitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0011 events1 affected538 at risk
Arrhythmia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected542 at risk EG0010 events0 affected538 at risk
Arteriosclerosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Atrial fibrillation	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Atrial flutter	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Basal cell carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Benign prostatic hyperplasia	Reproductive system and breast disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Benign renal neoplasm	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Bile duct stone	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Bladder cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Bowen's disease	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Breast cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Bronchitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected542 at risk EG0010 events0 affected538 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected542 at risk EG0013 events3 affected538 at risk
Cardiac arrest	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0012 events2 affected538 at risk
Cardiac failure	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0003 events3 affected542 at risk EG0010 events0 affected538 at risk
Cardiac failure acute	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Cardiac failure congestive	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Cardiac pacemaker replacement	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Cellulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Cerebral artery embolism	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Cerebral atrophy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Cholecystitis infective	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected542 at risk EG0010 events0 affected538 at risk
Clostridium difficile colitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Cognitive disorder	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Colorectal cancer	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Coronary artery disease	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected542 at risk EG0015 events5 affected538 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Death	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0012 events2 affected538 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Diverticulitis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Drug intolerance	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Endometrial adenocarcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Eosinophilic oesophagitis	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Fall	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Gangrene	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Gastric ulcer	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Gout	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Hepatic enzyme increased	Investigations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Herpes zoster infection neurological	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Hip fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Hyperkalaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Hypertensive urgency	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Hypertrophic cardiomyopathy	Congenital, familial and genetic disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0012 events2 affected538 at risk
Hypotension	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Hypothyroidism	Endocrine disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Ileus	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Inguinal hernia	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Intracranial pressure increased	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Invasive breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Invasive ductal breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Invasive lobular breast carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Large intestine polyp	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Localised oedema	General disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Loss of consciousness	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Lumbar radiculopathy	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Lung cancer metastatic	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Malignant melanoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Malnutrition	Metabolism and nutrition disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Metastases to liver	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0011 events1 affected538 at risk
Myocardial infarction	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0012 events2 affected538 at risk
Myocardial ischaemia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Nephrolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Non-cardiac chest pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Ocular ischaemic syndrome	Eye disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Osteochondrosis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Pain	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Palpitations	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Pancreatic carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0011 events1 affected538 at risk
Pancytopenia	Blood and lymphatic system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Peripheral swelling	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Periprocedural myocardial infarction	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Peritonsillar abscess	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Pneumonia	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0002 events2 affected542 at risk EG0010 events0 affected538 at risk
Post procedural complication	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Post procedural haematuria	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Post procedural inflammation	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Pulmonary mass	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Respiratory failure	Respiratory, thoracic and mediastinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Rheumatoid arthritis	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Road traffic accident	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Skin neoplasm excision	Surgical and medical procedures	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Skin ulcer	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Small intestinal obstruction	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Stress urinary incontinence	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Supraventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Sweat gland infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Systemic inflammatory response syndrome	General disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Transient ischaemic attack	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Trigger finger	Musculoskeletal and connective tissue disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Upper limb fracture	Injury, poisoning and procedural complications	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Urosepsis	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Urticaria	Skin and subcutaneous tissue disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Uterine leiomyoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Venous stenosis	Vascular disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Vertigo positional	Ear and labyrinth disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
Vomiting	Gastrointestinal disorders	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk
White matter lesion	Nervous system disorders	MedDRA 24.1	Systematic Assessment	EG0000 events0 affected542 at risk EG0011 events1 affected538 at risk
Wound infection	Infections and infestations	MedDRA 24.1	Systematic Assessment	EG0001 events1 affected542 at risk EG0010 events0 affected538 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
COVID-19	Infections and infestations	MedDRA 24.1	Systematic Assessment		EG00046 events43 affected542 at risk EG00157 events55 affected538 at risk

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
C000712207	insulin icodec
D000069036	Insulin Glargine
C571886	insulin degludec

Ancestor Terms

ID	Term
D049528	Insulin, Long-Acting
D061385	Insulins
D010187	Pancreatic Hormones
D036361	Peptide Hormones
D006728	Hormones
D006730	Hormones, Hormone Substitutes, and Hormone Antagonists
D010455	Peptides
D000602	Amino Acids, Peptides, and Proteins

Participants were to receive once daily basal insulin analogue of (Insulin degludec using PDS290 prefilled pen-injector) or (Insulin glargine U100 or Insulin glargine U300 using SoloSTAR® pre-filled pen-injector) for 52 weeks, at a dose in accordance with local label. Titration of once daily basal insulin analogue comparators is at the discretion of the investigator according to local clinical practice. The recommended doses for all once daily basal insulin analogues was based on the locally approved label.

ID	Term
D003920	Diabetes Mellitus
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases