A Research Study to See How Well the New Weekly Medicine... | NCT05259033

NCT05259033

ID	Type	Description	Link
U1111 1260 8268	Other Identifier	World Health Organization (WHO)
2020 005308 21	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
IcoSema	Experimental	Participants will get once weekly dose	Drug: IcoSema
Semaglutide	Experimental	Participants will get once weekly dose	Drug: Semaglutide 1 mg

Name	Type	Description	Arm Group Labels	Other Names
IcoSema	Drug	IcoSema once weekly subcutaneously (s.c., under the skin) using a needle and a pen. For about 1 year and 1 month.	IcoSema

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in Glycosylated Haemoglobin (HbA1c)	Change from baseline (week 0) to week 52 in HbA1c is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.	Baseline (week 0), (week 52)

Secondary Outcomes

Measure	Description	Time Frame
Change From Baseline in Fasting Plasma Glucose (FPG)	Change from baseline (week 0) to week 52 in FPG is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female and age above or equal to 18 years at the time of signing informed consent.
Diagnosed with type 2 diabetes mellitus 180 days or more before screening.
HbA1c of 7.0 - 10.0% (53.0 - 85.8 mmol/mol) (both inclusive) as assessed by central laboratory on the day of screening.
Insulin naïve. The following exceptions are permitted: short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes.
Treated with stable doses of daily or weekly GLP-1 receptor agonist (excluding once weekly semaglutide with doses higher than 1.0 mg) according to local label for the treatment of diabetes for 90 days or more before screening. The treatment can be with or without any of the following anti diabetic drugs with stable doses for 90 days or more before screening: Metformin - Sulfonylureas (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Meglitinides (glinides)(Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - DPP 4 inhibitors (Sulfonylureas, meglitinides (glinides) and DPP 4 inhibitors must be discontinued at randomisation) - Sodium glucose co transporter 2 inhibitors - Alpha-glucosidase inhibitors - Thiazolidinediones - Marketed oral combination products only including the products listed above.
Body mass index (BMI) below or equal to 40.0 kg/m^2.

Exclusion Criteria:

Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using a highly effective contraceptive method.
Anticipated initiation or change in concomitant medication (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or systemic corticosteroids).
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening.
Any episodes (as declared by the participant or in the medical records) of diabetic ketoacidosis within 90 days before screening.
Presence or history of pancreatitis (acute or chronic) within 180 days before screening.
Any of the following: Myocardial infarction, stroke, hospitalization for unstable angina pectoris or transient ischaemic attack within 180 days before screening.
Chronic heart failure classified as being in New York Heart Association Class IV at screening.
Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days before screening or in the period between screening and randomisation. Pharmacological pupil dilation is a requirement unless using a digital fundus photography camera specified for non dilated examination

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 AL at Birmingham_BRM		Birmingham	Alabama	35294	United States
Pri Med Grp dba/Gil Ctr Fam

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39820580	Derived	Lingvay I, Benamar M, Chen L, Fu A, Jodar E, Nishida T, Riveline JP, Yabe D, Zueger T, Rea R. Once-weekly IcoSema versus once-weekly semaglutide in adults with type 2 diabetes: the COMBINE 2 randomised clinical trial. Diabetologia. 2025 Apr;68(4):739-751. doi: 10.1007/s00125-024-06348-5. Epub 2025 Jan 17.

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.

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	Mar 23, 2023	Dec 11, 2024

Derived Section

Miscellaneous Info Module

Submission Tracking

Condition Browse Module

Intervention Browse Module

Masking Info

Full analysis set (FAS) included all randomised participants.

Arm/Group Information

ID	Title	Description
BG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.
BG001	Semaglutide	Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams [mg], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.
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
	BG00059.9± 10.5 BG00158.3± 9.8 BG00259.1± 10.2

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000141 BG001145 BG002

Ethnicity (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Hispanic or Latino	BG00037 BG00137 BG002

Race (NIH/OMB)

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
American Indian or Alaska Native	BG0001 BG0010 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 From Baseline in Glycosylated Haemoglobin (HbA1c)

Change from baseline (week 0) to week 52 in HbA1c is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.

Full Analysis Set (FAS) which comprised all randomised participants. Overall number of participants analyzed = participants with available data for this outcome measure.

Posted

Mean

Standard Deviation

Percentage point of HbA1c

Baseline (week 0), (week 52)

ID	Title	Description
OG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.
OG001	Semaglutide	Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams [mg], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.

Units	Counts
Participants	OG000325 OG001335

Title

Denominators

Categories

Title	Measurements
	OG000-1.40± 0.91 OG001-0.86± 0.96

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	Treatment policy strategy	ANCOVA		<0.0001		Estimated treatment difference	-0.44			2-Sided	95	-0.56	-0.33					Superiority	Responses were analysed using an analysis of covariance (ANCOVA) model with region and randomised treatment as fixed factors and baseline HbA1c as covariate. Each imputed dataset is analysed separately and estimates are combined using Rubin's rules.

Secondary

Change From Baseline in Fasting Plasma Glucose (FPG)

Change from baseline (week 0) to week 52 in FPG is presented.The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.

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

Posted

Mean

Standard Deviation

Millimoles per litre (mmol/L)

Baseline (week 0), (week 52)

ID	Title	Description
OG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.
OG001	Semaglutide

Secondary

Change From Baseline in Body Weight

Change from baseline (week 0) to week 52 in body weight is presented. The outcome measure was evaluated based on the data from in study period, where all data from randomisation until last date of any of the following: 1) last direct participant-site contact; 2) participants who withdrew their informed consent; 3) last participant-investigator contact as defined by the investigator for participants who lost to follow-up (i.e. possibly an unscheduled phone visit); 4) death of participants who died before any of the above.

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

Posted

Mean

Standard Deviation

Kilogram (kg)

Baseline (week 0), (week 52)

ID	Title	Description
OG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.
OG001	Semaglutide

Secondary

Number of Clinically Significant Hypoglycaemic Episodes (Level 2) (<3.0 mmol/L (54 Milligram Per Decilitre [mg/dL]) , Confirmed by Blood Glucose [BG] Meter) or Severe Hypoglycaemic Episodes (Level 3)

Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was less than (<) 3.0 mmol/L (54 mg/dL) and level 3 had no specific glucose threshold. The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1)last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.

Safety Analysis Set (SAS) included all participants exposed to randomised treatment.

Posted

Number

Episodes

Week 0 to Week 57

ID	Title	Description
OG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.

Secondary

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

Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 2 was < 3.0 mmol/L (54 mg/dL). The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1)last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.

SAS included all participants exposed to randomised treatment.

Posted

Number

Episodes

Week 0 to Week 57

ID	Title	Description
OG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.
OG001

Secondary

Number of Severe Hypoglycaemic Episodes (Level 3)

Hypoglycaemic episodes were classified according to the American Diabetes Association/ International Hypoglycaemia Study Group, where glycemic criteria for level 3 had no specific glucose threshold.The outcome measure was evaluated based on data from on treatment period, where all data from date of first dose of randomised treatment as recorded on the electronic case report form (eCRF) until the first date of any of the following: 1)last follow-up visit (V56); 2) last date on randomised treatment +6 weeks (corresponding to 5 weeks after the end of the dosing interval for both treatment arms); 3) end-date for the in-study data points sets.

SAS included all participants exposed to randomised treatment.

Posted

Number

Episodes

Week 0 to Week 57

ID	Title	Description
OG000	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.
OG001	Semaglutide

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	IcoSema	Participants received once weekly 700 units per millilitre (U/mL) of insulin icodec and 2 milligram per millilitre (mg/mL) of semaglutide subcutaneously for 52 weeks. 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: < 4.4 mmol/L: dose re-duced by 10 U; 4.4-7.2 mmol/L: no adjustment; > 7.2 mmol/L: dose increased by 10 U. Dose titration of IcoSema was based on the respective premeal(s) and bedtime self-measured plasma glucose (SMPG) measured weekly.	2	342	38	341	163	341
EG001	Semaglutide	Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams [mg], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.	0	341	21	340	159	340

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Abdominal sepsis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Acoustic neuroma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Acute kidney injury	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0011 events1 affected340 at risk
Acute myocardial infarction	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected341 at risk EG0010 events0 affected340 at risk
Adenocarcinoma of colon	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Angina pectoris	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Angina unstable	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Appendicitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Arteriosclerosis coronary artery	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Cardiac failure chronic	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Cardioversion	Surgical and medical procedures	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Cataract	Eye disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0012 events1 affected340 at risk
Cerebral infarction	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Cerebrovascular accident	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected341 at risk EG0010 events0 affected340 at risk
Chest pain	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Cholecystitis acute	Hepatobiliary disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected341 at risk EG0011 events1 affected340 at risk
Colon dysplasia	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Colorectal adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Coronary artery disease	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Coronary artery stenosis	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Decreased appetite	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Deep vein thrombosis	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Depression	Psychiatric disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Diabetic ketoacidosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Dyspnoea	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Erysipelas	Infections and infestations	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Femoral neck fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0003 events3 affected341 at risk EG0011 events1 affected340 at risk
Femur fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Food poisoning	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Gastrointestinal haemorrhage	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Hydronephrosis	Renal and urinary disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Hypertension	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Hypovolaemic shock	Vascular disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0002 events2 affected341 at risk EG0010 events0 affected340 at risk
Ischaemic stroke	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Ketoacidosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Lactic acidosis	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Left ventricular failure	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Lumbar spinal stenosis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0012 events2 affected340 at risk
Meniscus injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Migraine without aura	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Myocardial infarction	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Nausea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Optic ischaemic neuropathy	Eye disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Osteoarthritis	Musculoskeletal and connective tissue disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Otitis media	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Otitis media chronic	Infections and infestations	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Ovarian adenoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Pancreatitis acute	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Patella fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Peripheral arterial occlusive disease	Vascular disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Pneumonia	Infections and infestations	MedDRA 26	Systematic Assessment	EG0002 events2 affected341 at risk EG0011 events1 affected340 at risk
Prostatitis	Reproductive system and breast disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Spinal column injury	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Spinal fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Squamous cell carcinoma of head and neck	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Squamous cell carcinoma of the tongue	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Sudden death	General disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Type 2 diabetes mellitus	Metabolism and nutrition disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Ulna fracture	Injury, poisoning and procedural complications	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
VIth nerve paralysis	Nervous system disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Ventricular extrasystoles	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0010 events0 affected340 at risk
Ventricular tachycardia	Cardiac disorders	MedDRA 26	Systematic Assessment	EG0000 events0 affected341 at risk EG0011 events1 affected340 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG0001 events1 affected341 at risk EG0011 events1 affected340 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
COVID-19	Infections and infestations	MedDRA 26	Systematic Assessment	EG00052 events51 affected341 at risk EG00153 events49 affected340 at risk
Constipation	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00014 events11 affected341 at risk EG00126 events17 affected340 at risk
Diabetic retinopathy	Eye disorders	MedDRA 26	Systematic Assessment	EG00020 events19 affected341 at risk EG00110 events10 affected340 at risk
Diarrhoea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00053 events38 affected341 at risk EG00182 events41 affected340 at risk
Headache	Nervous system disorders	MedDRA 26	Systematic Assessment	EG00025 events20 affected341 at risk EG0016 events6 affected340 at risk
Nasopharyngitis	Infections and infestations	MedDRA 26	Systematic Assessment	EG00045 events33 affected341 at risk EG00145 events33 affected340 at risk
Nausea	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00065 events40 affected341 at risk EG00173 events39 affected340 at risk
Upper respiratory tract infection	Infections and infestations	MedDRA 26	Systematic Assessment	EG00034 events22 affected341 at risk EG00134 events29 affected340 at risk
Vomiting	Gastrointestinal disorders	MedDRA 26	Systematic Assessment	EG00024 events17 affected341 at risk EG00148 events22 affected340 at risk

First MCP Posted Date

ID	Term
D003924	Diabetes Mellitus, Type 2

ID	Term
C000591245	semaglutide

Participants received once weekly semaglutide subcutaneously in a dose escalation manner, with dose increases every 4 weeks for up to week 8 (0.25 milligrams [mg], 0.5 mg) followed by dose of 1.0 mg once weekly up to the end of treatment period.

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