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

Sponsor
Ministry of Health, Saudi Arabia
Study ID
NCT06057077
Phase
PHASE1/PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 35 Years
Healthy Volunteers
Accepted

Interventions

  • Semaglutide weekly injection — DRUG
    semaglutide is Glp1 AGONIST WHICH IS NEW CHALLENGE IN DIABETES DISEASE TREATMENT EITHER TYPE 2 AND IS APPROVED BY FDA FOE children aged above 12 years at obesity

Study Details

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

Key Dates

Start date
Jan 1, 2024
Status verified
Sep 2023
Primary completion
Dec 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: 60 early type 1 diabetes with semaglutide and degludec basal bolus insulin
    degludec administered once daily bolus insulin three times daily and time in range and Semaglutide once weekly
  • No Intervention: 60 early type 1 diabetes with degludec basal bolus insulin with regular standard of care
    60 patients' Basal insulin degludec administered once daily according to the SMBG and continuous plan at the clinic bolus insulin three times daily according to the meals and time in range and carbohydrate index Dosing adjusted based on SMBG results

Primary Outcome Measure

change 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 [ Time Frame: Time Frame: one year ]

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