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NCT06115460

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

Completed Phase 3 Last updated 7 November 2023
What this trial tests

Phase 3 trial testing oral sitagliptin supplementation in Type 1 Diabetic Nephropathy in 46 participants. Completed in 15 June 2023.

Timeline
1 March 2022
Primary endpoint
1 June 2023
15 June 2023

Quick facts

Lead sponsorAin Shams University
PhasePhase 3
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment46
Start date1 March 2022
Primary completion1 June 2023
Estimated completion15 June 2023
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Ain Shams University

Who can join

Adults 12 to 18, any sex, with Type 1 Diabetic Nephropathy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diabetic nephropathy (DN) is one of the most frequent microvascular complications of diabetes mellitus, affecting 25 to 40% of patients with type 1 diabetes (T1DM). Early diagnosis, appropriate patient follow-up and treatment are essential to improve the outcomes. There is a need for improvements in insulin therapy for people with T1DM as the majority of patients are struggling to achieve glycemic targets. Technological advancements and oral adjuncts to insulin therapies are starting to be licensed for the use of people with T1DM. Dipeptidyl peptidase-4 (DPP-4), a multifunctional serine protease with a dual function (regulatory protease and binding protein), can modulate inflammation and immune cell-mediated β-cell destruction. DPP-4 degrades the peptide hormones glucagon-like peptide 1 (GLP-1) and gastric inhibitory peptide (GIP). Several studies have suggested that the upregulated DPP-4 activity is correlated with T1DM pathophysiology.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. The DPP-4 inhibitor sitagliptin improves glycaemic control and early-stage diabetic nephropathy in adolescents with type 1 diabetes using the MiniMed 780G advanced hybrid closed-loop system: a randomised controlled trial.
    Elbarbary NS, Ismail EA, El-Hamamsy MH, Ibrahim MZ, et al · · 2024 · cited 6× · PMID 39271520 · DOI 10.1007/s00125-024-06265-7

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Other Ain Shams University trials

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