Safety Study of Weekly Semaglutide in Chilean Participants With Type 2 Diabetes

Number of adverse events from baseline (Day 1) to week 24 is presented. An adverse event is any untoward medical occurrence in a clinical study participant that is temporally associated with the use of investigational medicinal product (IMP), whether or not considered related to the IMP. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Change in glycosylated haemoglobin (HbA1c) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Participants achieving HbA1c less than 7.0% (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in fasting plasma glucose (FPG) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in body weight from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in waist circumference from baseline (week 1) to week 24 is presented. Waist circumference is defined as the minimal abdominal circumference located midway between the lower rib margin and the iliac crest. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Participants achieving greater than or equal (≥) 5% weight reduction (Yes/No) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Participants achieving greater than or equal (≥) 10% weight reduction (Yes/No) from baseline (week 1) to week is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in total cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in low density lipoprotein (LDL) cholesterol (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in high density lipoprotein (HDL) cholesterol (mg/dL) cholesterol from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in triglycerides (mg/dL) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in estimated glomerular filtration rate (eGFR) [millilitre per minute (mL/min) per 1.73 square meter (m^2)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Change in Urine Albumin-Creatinine Ratio (UACR) [milligram per gram (mg/g)] from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.

Participants discontinued due to adverse events (treatment discontinuation) from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Number of severe hypoglycaemic episodes from baseline (week 1) to week 24 is presented. Hypoglycaemic episodes were classified as severe if there was no specific glucose threshold but were associated with severe cognitive impairment requiring external assistance for recovery. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit.

Number of severe or blood glucose confirmed symptomatic hypoglycaemic episodes from baseline (week 1) to week 24 is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), follow-up visit, premature discontinuation follow-up visit.

Number of serious adverse events (SAEs) from baseline (week 1) to week 24 is presented. An SAE is any untoward medical occurrence that fulfils at least one of the following criteria: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; is a congenital anomaly/birth defect; important medical event. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Number of adverse reactions (ARs) from baseline (week 1) to week 24 is presented. Adverse reaction is an undesired effect of a drug or other type of treatment that can range from mild to severe and can be life-threatening. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Number of serious adverse reactions (SARs) from baseline (week 1) to week 24 is presented. Serious adverse reaction is an adverse reaction that results in death, is life-threatening, requires hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, or is a birth defect. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Number of suspected unexpected serious adverse reactions (SUSARs) per participant from baseline (week 1) to week 24 is presented. SUSAR is a serious adverse event which is unexpected and regarded as possibly or probably related to the trial product. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period ends at the first date of any of the following: follow-up visit, premature discontinuation follow-up visit, last date on study product + 42 days for safety and +7 days for efficacy, end-date for the 'in-trial' observation period.

Change from baseline in heart rate (pulse) after 24 weeks of treatment is presented. The outcome measure was evaluated based on the data from on-treatment observation period which was defined as the time period where sub-set of the 'in-trial' observation period and represents the time period where participants are considered exposed to study product. The observation period starts at the date of first dose of study product and ends at any of the following: end of treatment (week 24), premature discontinuation follow-up visit.