NCT05478707 (KML002) is a Phase 2 clinical trial of Dulaglutide in Diabetes Mellitus, Type 1, sponsored by University of Virginia.

Who is sponsoring NCT05478707?

NCT05478707 is sponsored by University of Virginia.

What drugs are being tested in NCT05478707?

Interventions in NCT05478707: Dulaglutide, Placebo.

What condition does NCT05478707 study?

NCT05478707 studies Diabetes Mellitus, Type 1, Endothelial Dysfunction.

Is NCT05478707 still recruiting?

NCT05478707 is currently suspended. Last updated 9 April 2026.

Last reviewed 2026-04-09 · How we verify

NCT05478707: KML002

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Therapeutic Strategies for Microvascular Dysfunction in Type 1 Diabetes

Suspended Phase 2 Last updated 9 April 2026

What this trial tests

Phase 2 trial testing Dulaglutide in Diabetes Mellitus, Type 1 in 47 participants. Suspended.

Timeline

5 October 2023

Primary endpoint
30 June 2028

30 July 2028

Quick facts

Lead sponsor	University of Virginia
Phase	Phase 2
Status	Suspended
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	basic science
Enrollment	47
Start date	5 October 2023
Primary completion	30 June 2028
Estimated completion	30 July 2028
Sites	1 location across United States

Drugs / interventions tested

Dulaglutide (DULAGLUTIDE) — full drug profile →
Placebo

Conditions studied

Diabetes Mellitus, Type 1 — all drugs for Diabetes Mellitus, Type 1 →
Endothelial Dysfunction — all drugs for Endothelial Dysfunction →

Sponsor

University of Virginia

Who can join

Adults 18 to 40, any sex, with Diabetes Mellitus, Type 1 or Endothelial Dysfunction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The investigators will test the hypothesis that, in adults with type 1 diabetes (T1D), glucagon-like peptide-1 receptor agonism (GLP-1RA, i.e. dulaglutide) enhances insulin-mediated skeletal muscle microvascular perfusion via attenuating endothelial oxidative stress and thereby improving endothelial function.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

The emergence of obesity in type 1 diabetes.
Kueh MTW, Chew NWS, Al-Ozairi E, le Roux CW. · · 2024 · cited 57× · PMID 38092958 · DOI 10.1038/s41366-023-01429-8
Metabolic interventions as adjunctive therapies to insulin in type 1 diabetes: Current clinical landscape and perspectives.
Podobnik J, Prentice KJ. · · 2025 · cited 5× · PMID 39757938 · DOI 10.1111/dom.16154

Verify or expand the search:

Other trials of Dulaglutide

Trials testing the same drug.

NCT07417618 — INcreTin-based thERapies for Cardiovascular Event PrevenTion in Patients With and Without ASCVD (INTERCEPT-ASCVD) · active not recruiting
NCT07282041 — Role of GLP1 RA Dulaglutide on Severe Intracranial Atherosclerosis · Phase 2, PHASE3 · recruiting
NCT06851962 — Impact of Pharmacogenetic-Guided Treatment on Type 2 Diabetes. · Phase 4 · active not recruiting
NCT06779929 — Comparative Study of Tirzepatide Versus Dulaglutide (SURPASS CVOT) or Semaglutide on Major Cardiovascular Events in Part · completed
NCT07088718 — Prediction of the SURPASS-CVOT Cardiovascular Outcome Trial in Healthcare Claims Data · completed

Other recruiting trials for Diabetes Mellitus, Type 1

Currently open trials in the same condition.

NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
NCT07305805 — A Research Study of a New Medicine NNC0363-1063 in Participants With Type 1 Diabetes · Phase 1 · recruiting
NCT06282055 — Trajectories in Insulin Sensitivity Across MEnstrual cycleS in Women With Type 1 Diabetes · recruiting
NCT06325202 — Closed Loop and Education for Hypoglycemia Awareness Restoration · NA · recruiting
NCT07160816 — A Research Study to See How Insulin Icodec Helps People With Type 1 Diabetes Control Their Blood Sugar · recruiting

Other University of Virginia trials

Trials by the same sponsor.

NCT05880355 — Multimodality Cardiovascular Imaging for the Translation of Therapies for Vascular Activation After MI · EARLY_PHASE1 · not yet recruiting
NCT07405645 — Stereotactic MRI-guided Focused Ultrasound Mesencephalotomy · NA · recruiting
NCT07146685 — Effect of Local Anesthetic Concentration on Rebound Pain: A Randomized Control Study · Phase 4 · not yet recruiting
NCT07298941 — Resilience Enhancement Following Sleep Treatment · Phase 2 · recruiting
NCT07036315 — Meaning in Music-Based Pain Modulation · NA · recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05478707 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 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 University of Virginia
Last refreshed: 9 April 2026

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/NCT05478707.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing