GLPwatch

Semaglutide GLP1 Agonists With Degludec Basal-bolus Insulin in Early Type 1 Diabetes to Basal-bolus

NCT06057077 · Unknown status

Last updated 2026-05-28

This clinical trial is testing whether adding semaglutide (a GLP-1 agonist) to insulin degludec (a basal insulin) in people with early type 1 diabetes can safely reduce or maintain their daily insulin doses over one year.

Status Unknown status The sponsor has not confirmed the status recently.
Phase Phase1, Phase2
Type Interventional (clinical trial)
Design Randomized, single-blind treatment study
Participants 120 people Planned (estimated).
Who can join Ages 18–35 · all sexes Healthy volunteers accepted.
Timeline Started 2024-01 · est. completion 2024-12

What this study is testing ClinicalTrials.gov NCT06057077 ↗

Description as written by the study sponsor.

type 1 diabetes is an autoimmune disease and still, some unknown mechanisms are undiscovered millions of children and adults suffer from this type which need basal-bolus insulin as the classical regimen, and basal-bolus insulin is the best type of treatment is similar to the physiological pattern, so our target and may studies before how to preserve the residual beta cells or postpone the complete destruction or extend the honeymoon stage to improve quality of life, the most challenge at type 1 diabetes is diabetic ketoacidosis which affect the quality of life and risk of death so at our clinical trials using the combination of basal insulin-like degludec as its action extend to 72 hours and has high flexibility and less hypoglycemic events and has an affinity to 99% to albumin so may be considered the most type of insulin is similar to human physiological insulin as 50% of insulin pass through portal circulation so no insulin until now it is mimic the normal physiological insulin but IDeg is the nearest to normal until now, Objective: To compare the efficacy and safety of basal-bolus insulin degludec and semaglutide with regular standard of care versus basal-bolus insulin with regular standard of care in early type 1 diabetic patients. In our study, the investigators will compare 2 groups of early type 1 patients in the age group 18 years to 35 years Protocol and Methodology for a Randomized Controlled Trial of Basal-Bolus Insulin Degludec and Semaglutide with Regular Standard of Care Versus Basal-Bolus Insulin with Regular Standard of Care in Early Type 1 Diabetic Patients Study Design: Randomized, controlled, open-label trial Setting: Outpatient diabetes clinics Participants: Early type 1 diabetic patients (aged 18-35 years) who have been diagnosed with type 1 diabetes for less than 2 years and have a hemoglobin A1c (HbA1c) of 7.0-11%. the tests will be done pre- and post : 1. Anti GAD 65 and anti IA2 2. HA1C 3. Serum C peptide 4. fasting insulin 5. serum zinc

Treatments tested

Main thing measuredchange in HA1c and mounts of insulin of basal and bolus which will be taken daily is the same or decreased after one year of follow up
SponsorMinistry of Health, Saudi Arabia
Conditions studiedType 1 Diabetes
GLP-1 drugs semaglutide

Full protocol, eligibility, and contacts on ClinicalTrials.gov NCT06057077 ↗