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NCT06115460
The Impact of Sitagliptin as an Add on Therapy With Closed Loop Control in Adolescents With Diabetic Nephropathy
Phase 3 trial testing oral sitagliptin supplementation in Type 1 Diabetic Nephropathy in 46 participants. Completed in 15 June 2023.
1 June 2023
Quick facts
| Lead sponsor | Ain Shams University |
|---|---|
| Phase | Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 46 |
| Start date | 1 March 2022 |
| Primary completion | 1 June 2023 |
| Estimated completion | 15 June 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- oral sitagliptin supplementation — full drug profile →
Conditions studied
- Type 1 Diabetic Nephropathy — all drugs for Type 1 Diabetic Nephropathy →
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):
-
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
Verify or expand the search:
- PubMed search for NCT06115460
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06115460 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Ain Shams University
- Last refreshed: 7 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06115460.
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