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

What Was Tested

This registered phase 4 trial tested Semaglutide.

This study is testing the safety and tolerability of subcutaneous semaglutide in participants with type 2 diabetes (T2D) in Chile.

The study will last for about 24 weeks.

It had 1 arm (groups): Semaglutide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 104 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Participants diagnosed (clinically) with type 2 diabetes greater than equal to (≥) 90 days prior to the screening visit. Participants in which Ozempic is indicated according to approved local label. Fundoscopy/Fundus photography record less than equal to (≤) 12 months.

The full record lists 5 inclusion and 18 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Semaglutide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-04-25 with completion listed for 2024-01-18.

It ran at 3 sites in Chile (3).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Number of Adverse Events (AEs) (time frame: From baseline (Day 1) up to 24 weeks).

It also tracked 21 secondary outcomes, for example Change in Glycosylated Haemoglobin (HbA1c), Participants Achieving HbA1c Less Than (<) 7.0 Percentage (%) [Yes/No], Change in Fasting Plasma Glucose (FPG) [Milligrams Per Decilitre (mg/dL)], Change in Body Weight (Kilogram [Kg]), Change in Waist Circumference [Centimeter (cm)] and Change in Total Cholesterol (mg/dL).

What This Means in Plain Language

Put simply, this is a phase 4 trial of Semaglutide in 104 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Semaglutide compound page, all human trials.