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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-03-23

Study Completion Date

2023-04-21

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Diabetic Nephropathy

NCT06115460

Type 1 Diabetic Nephropathy

COMPLETED PHASE3

Vildagliptin and the Glucagon Response to Hypoglycemia in Insulin-Treated Patients With Type 2 Diabetes

NCT01219400

Diabetes

COMPLETED PHASE4

Feed-Back Suppression of Meal-Induced Glucagon-like Peptide 1 (GLP-1) Secretion

NCT02749032

Type 2 Diabetes

COMPLETED PHASE1

Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes

NCT01901861

Type 2 Diabetes

COMPLETED NA

DPP4 Inhibition & Beta Cell Function

NCT02683187

Healthy

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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 .

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Time in Range

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Dipeptidyl peptidase-4 inhibitors

Dipeptidyl peptidase-4 inhibitors with Iftar meal

Group Type ACTIVE_COMPARATOR

Dipeptidyl peptidase-4 inhibitors

Intervention Type DRUG

Dipeptidyl peptidase-4 inhibitors with Iftar meal

Control group

No Dipeptidyl peptidase-4 inhibitors intake with Iftar meal

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Dipeptidyl peptidase-4 inhibitors

Dipeptidyl peptidase-4 inhibitors with Iftar meal

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

12 Years

Maximum Eligible Age

27 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No