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

NCT05533632 | Completed Phase 4 Results

• 2 other identifiers: NN9535-4844U1111-1281-5677
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Change in Glycosylated Haemoglobin (HbA1c)

  Baseline (week 1), week 24

• Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No]

  From baseline (week 1) to week 24

• Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)]

  Baseline (week 1), week 24

• Change in Body Weight (Kilogram [Kg])

  Baseline (week 1), week 24

• Change in Waist Circumference [Centimeter (cm)]

  Baseline (week 1), week 24

Study Arms (1)

Semaglutide

EXPERIMENTAL

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

Interventions

Semaglutide DRUG

Participants will receive semaglutide s.c. injection once weekly in a dose escalation manner for 24 weeks.

Semaglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Known hypoglycaemic unawareness and/or recurrent severe hypoglycaemic episodes as judged by the investigator.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (3)

Servicios Médicos Godoy Limitada

Santiago, Región Metropolitana, 7500710, Chile

Location

Hospital San Juan de Dios_Santiago, Región Metropolitana

Santiago, Región Metropolitana, 8350429, Chile

Location

Hospital Padre Hurtado

Santiago, Región Metropolitana, 8880465, Chile

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

semaglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Clinical Reporting Office (2834)
• Organization: Novo Nordisk A/S

clinicaltrials@novonordisk.com

(+1) 866-867-7178

Study Officials

• Clinical Transparency dept. 2834

  Novo Nordisk A/S

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2022
• First Posted: September 9, 2022
• Study Start: April 25, 2022
• Primary Completion: January 18, 2024
• Study Completion: January 18, 2024
• Last Updated: September 24, 2025
• Results First Posted: February 10, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share

Locations

CL (3)