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A Research Study to See How a New Weekly Insulin, Insulin Icodec When Given Along With Semaglutide Helps in Reducing the Blood Sugar Level in Patients With Type 2 Diabetes
Plain-language guide to NCT05813912: phase 3 interventional trial of Semaglutide, 148 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05813912
- Phase
- phase 3
- Status
- completed
- Start
- 2023-09-22
- Completion (planned or actual)
- 2025-04-14
- Participants
- 148 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 3 trial tested Semaglutide.
Participants will get the medicine insulin icodec once a week in the first part of the study (run-in period-26 weeks).
It had 1 arm (groups): Insulin Icodec + Semaglutide (experimental).
The registry classes the interventions as drug.
Who Took Part
148 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: Diagnosed with type 2 diabetes (T2D) greater than or equal to (\>=) 180 days prior to the day of screening.
The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: presence or history of pancreatitis (acute or chronic) within 180 days before screening; chronic heart failure classified as being in new york heart association (nyha) class iv at screening; planned coronary, carotid or peripheral artery revascularization.
How the Study Was Run
Design: single-group and open-label.
Nothing was hidden in this open-label Semaglutide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2023-09-22 with completion listed for 2025-04-14.
It ran at 39 sites in Poland (16), Czechia (10), Malaysia (5), Serbia (4) and Thailand (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Glycated Haemoglobin (HbA1c) (time frame: Baseline (Week 26), Week 52).
It also tracked 8 secondary outcomes, for example Change in Mean 7-point Self-measured Plasma Glucose (SMPG) Profiles, Change in Mean Post-prandial Glucose Increment (Over All Meals), Change in Fasting Plasma Glucose (FPG), Number of Severe Hypoglycaemic Episodes (Level 3) and Change in Body Weight.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Semaglutide in 148 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.
Our Notes on the Compound
Semaglutide: The active ingredient in several prescription GLP-1 receptor agonist medicines (Ozempic, Wegovy, oral tablets).
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.