Feasibility of DPP-4 Inhibitor Therapy on Advanced Hybrid Closed Loop System

Time in Range Clinical Trial

Official title:

Feasibility of DPP-4 Inhibitor for the Treatment of Iftar-Related Glycemic Excursions in Patients With Type 1 Diabetes on MiniMed™ 780G Advanced Hybrid Closed Loop System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06021119
• Other study ID #: Ain Shams University 232212
• Status: Completed
• Phase: Phase 3
• Start date: March 23, 2023
• Est. completion date: April 21, 2023

Study information

• Verified date: August 2023
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Ramadan Iftar meal typically causes glucose excursions. Dipeptidyl peptidase-4 inhibitors increase serum concentrations of glucagon-like peptide-1 and thus, decrease blood glucose levels with low risk of hypoglycemia.

Aim: To investigate the efficacy and safety of vildagliptin as an add-on therapy among adolescents and young adults with type 1 diabetes mellitus (T1DM) on glucose excursions of Iftar Ramadan meals and glycemic metrics during advanced hybrid closed-loop (AHCL) treatment.

Description:

Current management of people with type 1 diabetes mellitus (T1DM) on intensive insulin therapy recognizes carbohydrates as the most important determinant of postprandial glycaemia; hence, worldwide guidelines recommend carbohydrates counting for determining pre-prandial insulin doses. Currently, the insulin to carbohydrate ratio (ICR) is frequently used to calculate the meal insulin dose. However, ICRs are considered difficult, ineffective and inaccurate for some patient, with an estimation error of around 20% in adults demonstrating only modest improvements in glycated hemoglobin (HbA1c). This lack of effectiveness and the wide variability using ICRs suggests it should be improved upon.

However, there have been only a few randomized control studies that investigated the efficacy and safety of DPP-4 inhibitors as an add-on drug in patients treated with basal insulin. Therefore, we conducted a one-month randomized control trial to investigate the efficacy and safety of DPP-4 inhibitors as an add-on therapy among adolescents and young adults with T1DM on glucose excursions of Iftar Ramadan meals and glucometrics during AHCL treatment .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 21, 2023
• Est. primary completion date: April 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 27 Years

Eligibility

Inclusion Criteria:

• patients with type 1 diabetes (T1DM )for at least one year

• patients aged 12-27 years

• patients using MiniMed 780G AHCL system (Medtronic, Northridge, CA, USA) at least 6 months before the study

• patients with minimum daily insulin requirement of more than 8 units

• patients willingness and ability to adhere to the study protocol, access to the internet and a computer system that met requirements for uploading the study pump data.

Exclusion Criteria:

• patients with any microvascular or macrovascular complications

• pregnancy, lactation

• patients who had a point-of-care screening HbA1c >10.0% (86 mmol/mol)

• patients with hypoglycemic unawareness or recurrent severe hypoglycemic episode in the last 6 months prior to recruitment

• patients with recurrent DKA (more than 2 episodes in the previous 6 months).

• patients with any chronic medical condition, current use of medications (other than insulin) that are known to affect blood glucose level.

• patients who had prior adverse reactions to the adjunctive agent

Related Conditions & MeSH terms

• Time in Range

Intervention

Drug:
• Dipeptidyl peptidase-4 inhibitors
Dipeptidyl peptidase-4 inhibitors with Iftar meal

Locations

Country	Name	City	State
Egypt	Nancy Elbarbary	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

Brazeau AS, Mircescu H, Desjardins K, Leroux C, Strychar I, Ekoe JM, Rabasa-Lhoret R. Carbohydrate counting accuracy and blood glucose variability in adults with type 1 diabetes. Diabetes Res Clin Pract. 2013 Jan;99(1):19-23. doi: 10.1016/j.diabres.2012.10.024. Epub 2012 Nov 10. — View Citation

Brown SA, Kovatchev BP, Raghinaru D, Lum JW, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Pinsker JE, Wadwa RP, Dassau E, Doyle FJ 3rd, Anderson SM, Church MM, Dadlani V, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Kollman C, Beck RW; iDCL Trial Research Group. Six-Month Randomized, Multicenter Trial of Closed-Loop Control in Type 1 Diabetes. N Engl J Med. 2019 Oct 31;381(18):1707-1717. doi: 10.1056/NEJMoa1907863. Epub 2019 Oct 16. — View Citation

Dyson PA, Twenefour D, Breen C, Duncan A, Elvin E, Goff L, Hill A, Kalsi P, Marsland N, McArdle P, Mellor D, Oliver L, Watson K. Diabetes UK evidence-based nutrition guidelines for the prevention and management of diabetes. Diabet Med. 2018 May;35(5):541-547. doi: 10.1111/dme.13603. — View Citation

Lakshman R, Boughton C, Hovorka R. The changing landscape of automated insulin delivery in the management of type 1 diabetes. Endocr Connect. 2023 Jul 31;12(8):e230132. doi: 10.1530/EC-23-0132. — View Citation

Wadwa RP, Reed ZW, Buckingham BA, DeBoer MD, Ekhlaspour L, Forlenza GP, Schoelwer M, Lum J, Kollman C, Beck RW, Breton MD; PEDAP Trial Study Group. Trial of Hybrid Closed-Loop Control in Young Children with Type 1 Diabetes. N Engl J Med. 2023 Mar 16;388(11):991-1001. doi: 10.1056/NEJMoa2210834. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak postprandial plasma glucose (PPG) level in mg/dl	peak postprandial plasma glucose (PPG) level in mg/dl	4 weeks
Secondary	Time in range %	Time in range %	4 weeks