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

Safety and Tolerability of Weekly Semaglutide 0.5 mg or 1.0 mg in Chilean Subjects With Type 2 Diabetes

This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile. Participants will get a once-weekly subcutaneous injection of semaglutide in doses decided by the study doctor's criteria, according to participant's personal needs. The study will last for about 24 weeks. Participants will have 4 clinic visits and 2 phone calls. Participants will have 3 laboratory tests during the study (blood and urine samples).

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Semaglutide

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Phase 4

Contacts and Locations

Study Locations

• Chile
  • Santiago, Región Metropolitana, Chile, 7500710
    • Servicios Medicos Godoy Limitada
  • Santiago, Región Metropolitana, Chile, 8350429
    • Hospital San Juan de Dios_Santiago, Región Metropolitana
  • Santiago, Región Metropolitana, Chile, 8880465
    • Hospital Padre Hurtado

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit.
• Stable daily dose of Oral Antidiabetic Drug (OAD) and/or insulin treatment for ≥ 60 days prior to the screening visit.
• HbA1c 7.5-10% (59-86 millimoles per mole [mmol/mol]) (both inclusive) in Visit 1.
• Participants in which Ozempic is indicated according to approved local label.
• Fundoscopy/Fundus photography record less than equal to (≤) 12 months.

Exclusion Criteria:

• Known or suspected hypersensitivity to study intervention(s) or related products.
• Previous participation in this study. Participation is defined as signed informed consent.
• Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
• Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before the screening visit, except Coronavirus Disease 2019 (COVID-19) related trials (this is allowed).
• Treatment with any glucagon-like peptide-1 receptor agonists (GLP-1 RA) medication prior to the screening visit.
• Any disorder which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma.
• History of pancreatitis (acute or chronic).
• Renal impairment defined as estimated glomerular filtration rate (eGFR) below 30 milliliters/minute (mL/min)/1.73 meter square (m^2) as per MDRD-4 (Modification of Diet in Renal Disease).
• Myocardial infarction, stroke or hospitalisation for unstable angina or transient ischaemic attack within the past 180 days prior to the day of screening.
• Participants presently classified as being in New York Heart Association (NYHA) Class IV heart failure.
• Planned coronary, carotid or peripheral artery revascularisation known on the day of screening.
• Participants with alanine aminotransferase (ALT) > 2.5 x upper normal limit (UNL).
• Use of systemic immunosuppressive treatment within 90 days prior to screening.
• Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before the day of screening. An exception is short-term insulin treatment for acute illness for a total of ≤ 14 days.
• Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.
• Proliferative retinopathy or maculopathy requiring acute treatment. Verified by fundus photography or dilated fundoscopy performed within 12 months prior to screening.
• History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and carcinoma in situ).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Semaglutide; Participants will receive semaglutide subcutaneous (s.c.) injection once weekly in a dose escalation manner for 24 weeks: 0.25 milligrams (mg) (weeks 1 to 4), 0.5 mg (weeks 5 to 12) and 0.5 mg or 1.0 mg (weeks 13 to 24).	Drug: Semaglutide; Participants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Adverse Events (AEs)	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.	From baseline (Day 1) up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Glycosylated Haemoglobin (HbA1c)	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.	Baseline (week 1), week 24
Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No]	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.	From baseline (week 1) to week 24
Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]	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.	Baseline (week 1), week 24
Change in Body Weight (Kilogram [Kg])	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.	Baseline (week 1), week 24
Change in Waist Circumference [Centimeter (cm)]	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.	Baseline (week 1), week 24
Participants Achieving Greater Than or Equal (≥) 5% Weight Reduction (Yes/No)	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.	From baseline (week 1) to week 24
Participants Achieving Greater Than or Equal (≥) 10% Weight Reduction (Yes/No)	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.	From baseline (week 1) to week 24
Change in Total Cholesterol (mg/dL)	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.	Baseline (week 1), week 24
Change in Low Density Lipoprotein (LDL) Cholesterol (mg/dL)	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.	Baseline (week 1), week 24
Change in High Density Lipoprotein (HDL) Cholesterol (mg/dL)	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.	Baseline (week 1), week 24
Change in Triglycerides (mg/dL)	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.	Baseline (week 1), week 24
Change in Estimated Glomerular Filtration Rate (eGFR) [Millilitre Per Minute (mL/Min) Per 1.73 Square Meter (m^2)]	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.	Baseline (week 1), week 24
Change in Urine Albumin-Creatinine Ratio (UACR) [Milligram Per Gram (mg/g)]	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.	Baseline (week 1), week 24
Participants Discontinued Due to Adverse Events (Treatment Discontinuation)	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.	From baseline (week 1) to week 24
Number of Severe Hypoglycaemic Episodes	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.	From baseline (week 1) to week 24
Number of Severe or Blood Glucose Confirmed Symptomatic Hypoglycaemic Episodes	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.	From baseline (week 1) to week 24
Number of Serious Adverse Events (SAEs)	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.	From baseline (week 1) to week 24
Number of Adverse Reactions (ARs)	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.	From baseline (week 1) to week 24
Number of Serious Adverse Reactions (SARs)	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.	From baseline (week 1) to week 24
Number of Suspected Unexpected Serious Adverse Reactions (SUSARs) Per Participant	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.	From baseline (week 1) to week 24
Change From Baseline in Heart Rate (Pulse) After 24 Weeks of Treatment	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.	Baseline (week 1), week 24

Collaborators and Investigators

• Sponsor: Novo Nordisk A/S
• Investigators: Study Director: Clinical Transparency dept. 2834, Novo Nordisk A/S

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2022
• Primary Completion (Actual): January 18, 2024
• Study Completion (Actual): January 18, 2024

Study Registration Dates

• First Submitted: September 6, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 9, 2022

Study Record Updates

• Last Update Posted (Estimated): September 24, 2025
• Last Update Submitted That Met QC Criteria: September 23, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; Glucagon-Like Peptide-1 Receptor Agonists; Physiological Effects of Drugs; Hypoglycemic Agents; semaglutide
• Other Study ID Numbers: NN9535-4844; U1111-1281-5677 (Other Identifier: World Health Organization (WHO))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: According to the Novo Nordisk disclosure commitment on novonordisk-trials.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No