NCT03794960 (DAY) is a Phase 2 clinical trial of TOL-3021 in Diabetes Mellitus, Type 1, sponsored by Tolerion, Inc..

Who is sponsoring NCT03794960?

NCT03794960 is sponsored by Tolerion, Inc..

What drugs are being tested in NCT03794960?

Interventions in NCT03794960: TOL-3021, TOL-3021 Placebo.

What condition does NCT03794960 study?

NCT03794960 studies Diabetes Mellitus, Type 1.

Is NCT03794960 still recruiting?

NCT03794960 is currently withdrawn. Last updated 8 December 2020.

Last reviewed 2020-12-08 · How we verify

NCT03794960: DAY

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

Diabetes AutoimmunitY Withdrawn in Established Patients (DAY)

Withdrawn Phase 2 Last updated 8 December 2020

What this trial tests

Phase 2 trial testing TOL-3021 in Diabetes Mellitus, Type 1. Withdrawn.

Timeline

14 December 2019

Primary endpoint
14 December 2021

14 December 2023

Quick facts

Lead sponsor	Tolerion, Inc.
Phase	Phase 2
Status	Withdrawn
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Start date	14 December 2019
Primary completion	14 December 2021
Estimated completion	14 December 2023

Drugs / interventions tested

TOL-3021 — full drug profile →
TOL-3021 Placebo

Conditions studied

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

Sponsor

Tolerion, Inc. — full company profile →

Who can join

Adults 12 to 36, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The study is a prospective, randomized, double-blind, placebo-controlled, multicenter trial in subjects with established T1D.

Publications & conference data

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

Biomedical Applications of Quantum Dots: Overview, Challenges, and Clinical Potential.
Abdellatif AAH, Younis MA, Alsharidah M, Al Rugaie O, et al · · 2022 · cited 104× · PMID 35530976 · DOI 10.2147/ijn.s357980
Therapeutic induction of antigen-specific immune tolerance.
Kenison JE, Stevens NA, Quintana FJ. · · 2024 · cited 94× · PMID 38086932 · DOI 10.1038/s41577-023-00970-x
Advancing Cancer Therapy with Quantum Dots and Other Nanostructures: A Review of Drug Delivery Innovations, Applications, and Challenges.
Pareek A, Kumar D, Pareek A, Gupta MM. · · 2025 · cited 20× · PMID 40075725 · DOI 10.3390/cancers17050878
Induction of Antigen-Specific Tolerance in T Cell Mediated Diseases.
Passerini L, Gregori S. · · 2020 · cited 16× · PMID 33133064 · DOI 10.3389/fimmu.2020.02194
Delivery route considerations for designing antigen-specific biomaterial strategies to combat autoimmunity.
Ackun-Farmmer MA, Jewell CM. · · 2023 · cited 15× · PMID 36938103 · DOI 10.1002/anbr.202200135

Verify or expand the search:

Other trials of TOL-3021

Trials testing the same drug.

NCT03794973 — Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN) · Phase 2 · withdrawn
NCT03895437 — Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients · Phase 2 · active not recruiting

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 Tolerion, Inc. trials

Trials by the same sponsor.

NCT03794973 — Diabetes Autoimmunity Withdrawn in New Onset Patients (DAWN) · Phase 2 · withdrawn
NCT03895437 — Diabetes Autoimmunity Withdrawn In New Onset and In Established Patients · Phase 2 · active not 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 NCT03794960 (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 Tolerion, Inc.
Last refreshed: 8 December 2020

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/NCT03794960.

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