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

NCT06057077 | Unknown Phase 1 DMC

• 1 other identifier: Amr Ahmed, Maher M.Akl
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

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. 1.Anti GAD 65 and anti IA2
2. 2.HA1C
3. 3.Serum C peptide
4. 4.fasting insulin
5. 5.serum zinc

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

  change in A1C and daily insulin requirements will be reduced at the end of one year from study was started

  Time Frame: one year

Secondary Outcomes (1)

• the change in weight after follow up of one year

  one year

Study Arms (2)

60 early type 1 diabetes with semaglutide and degludec basal bolus insulin

ACTIVE COMPARATOR

degludec administered once daily bolus insulin three times daily and time in range and Semaglutide once weekly

Drug: Semaglutide weekly injection

60 early type 1 diabetes with degludec basal bolus insulin with regular standard of care

NO INTERVENTION

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

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

Also known as: tresiba once daily

60 early type 1 diabetes with semaglutide and degludec basal bolus insulin

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• early diagnosed type 1 diabetic patients were diagnosed in the last 6 months age of two groups: from 18-35 years basal-bolus insulin patients

You may not qualify if:

• no oral hypoglycemic drugs no pregnancy no hypoglycemic drugs or immunosuppressant no history of diabetic ketoacidosis

Sponsors & Collaborators

• Ministry of Health, Saudi Arabia: lead

Related Publications (2)

• Ang JE, Pandher R, Ang JC, Asad YJ, Henley AT, Valenti M, Box G, de Haven Brandon A, Baird RD, Friedman L, Derynck M, Vanhaesebroeck B, Eccles SA, Kaye SB, Workman P, de Bono JS, Raynaud FI. Plasma Metabolomic Changes following PI3K Inhibition as Pharmacodynamic Biomarkers: Preclinical Discovery to Phase I Trial Evaluation. Mol Cancer Ther. 2016 Jun;15(6):1412-24. doi: 10.1158/1535-7163.MCT-15-0815. Epub 2016 Apr 5.

  PMID: 27048952 RESULT

• Ahmed A, Monir Akl M. Exploring a Synergistic Approach: Dual GLP-1 Agonist Combined with Degludec Basal Insulin for Early Type 1 Diabetes Treatment and its Impact on Albumin-Insulin Producing Cells Expression. Adv Pharm Bull. 2024 Jul;14(2):262-265. doi: 10.34172/apb.2024.040. Epub 2024 Mar 18.

  PMID: 39206389 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: public health department, MSc, Riaydh first health cluster, Ministry of health , Saudia arabia

Model Details: To compare the efficacy and safety of basal-bolus insulin degludec and semaglutide with the regular standard of care versus basal-bolus insulin with regular standard of care in early type 1 diabetic patients.

Study Record Dates

• First Submitted: September 15, 2023
• First Posted: September 28, 2023
• Study Start: January 1, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share