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

NCT06021119 | Completed Phase 3

• 1 other identifier: Ain Shams University 232212
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Time in Range

Outcome Measures

Primary Outcomes (1)

• peak postprandial plasma glucose (PPG) level in mg/dl

  peak postprandial plasma glucose (PPG) level in mg/dl

  4 weeks

Secondary Outcomes (1)

• Time in range %

  4 weeks

Study Arms (2)

Dipeptidyl peptidase-4 inhibitors

ACTIVE COMPARATOR

Dipeptidyl peptidase-4 inhibitors with Iftar meal

Drug: Dipeptidyl peptidase-4 inhibitors

Control group

NO INTERVENTION

No Dipeptidyl peptidase-4 inhibitors intake with Iftar meal

Interventions

Dipeptidyl peptidase-4 inhibitors DRUG

Dipeptidyl peptidase-4 inhibitors with Iftar meal

Dipeptidyl peptidase-4 inhibitors

Eligibility Criteria

• Age: 12 Years - 27 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Nancy Elbarbary

Cairo, 11361, Egypt

Location

Related Publications (6)

• 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.

  PMID: 29443421 BACKGROUND

• 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.

  PMID: 23146371 BACKGROUND

• 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.

  PMID: 31618560 BACKGROUND

• 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.

  PMID: 36920756 BACKGROUND

• 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.

  PMID: 37289734 BACKGROUND

• Elbarbary NS, Ismail EAR. Mitigating iftar-related glycemic excursions in adolescents and young adults with type 1 diabetes on MiniMed 780G advanced hybrid closed loop system: a randomized clinical trial for adjunctive oral vildagliptin therapy during Ramadan fasting. Diabetol Metab Syndr. 2023 Dec 7;15(1):257. doi: 10.1186/s13098-023-01232-5.

  PMID: 38057844 DERIVED

MeSH Terms

Interventions

Dipeptidyl-Peptidase IV Inhibitors

Intervention Hierarchy (Ancestors)

Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Hypoglycemic Agents; Physiological Effects of Drugs

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. of Pediatrics

Study Record Dates

• First Submitted: August 26, 2023
• First Posted: September 1, 2023
• Study Start: March 23, 2023
• Primary Completion: April 21, 2023
• Study Completion: April 21, 2023
• Last Updated: September 1, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)