NCT04291703 (TN28) is a Phase 2 clinical trial of Antithymocyte Globulin in Diabetes Mellitus, Type 1, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

Who is sponsoring NCT04291703?

NCT04291703 is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).

What drugs are being tested in NCT04291703?

Interventions in NCT04291703: Antithymocyte Globulin, Placebo (for ATG).

What condition does NCT04291703 study?

NCT04291703 studies Diabetes Mellitus, Type 1.

Is NCT04291703 still recruiting?

NCT04291703 is currently terminated. Last updated 25 September 2025.

Last reviewed 2025-09-25 · How we verify

NCT04291703: TN28

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

STOP-T1D Low-Dose (ATG)

Terminated Phase 2 Last updated 25 September 2025

What this trial tests

Phase 2 trial testing Antithymocyte Globulin in Diabetes Mellitus, Type 1 in 2 participants. Terminated before completion.

Timeline

1 November 2023

Primary endpoint
17 December 2024

17 December 2024

Quick facts

Lead sponsor	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	prevention
Enrollment	2
Start date	1 November 2023
Primary completion	17 December 2024
Estimated completion	17 December 2024
Sites	22 locations across United States, Australia

Drugs / interventions tested

Antithymocyte Globulin — full drug profile →
Placebo (for ATG) — full drug profile →

Conditions studied

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

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Who can join

Adults 6 to 34, any sex, with Diabetes Mellitus, Type 1. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

A multi-center, placebo-controlled, double blind, 2:1 randomized control clinical trial testing low-dose ATG vs. placebo in subjects with a 2 year 50% risk of progression to stage 3 T1D.

Publications & conference data

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

Therapeutic Antibodies in Medicine.
Sharma P, Joshi RV, Pritchard R, Xu K, et al · · 2023 · cited 38× · PMID 37764213 · DOI 10.3390/molecules28186438
Low-Dose ATG/GCSF in Established Type 1 Diabetes: A Five-Year Follow-up Report.
Lin A, Mack JA, Bruggeman B, Jacobsen LM, et al · · 2021 · cited 21× · PMID 33632742 · DOI 10.2337/db20-1103
Screening and Prevention of Type 1 Diabetes: Where Are We?
Simmons KM, Sims EK. · · 2023 · cited 17× · PMID 37290044 · DOI 10.1210/clinem/dgad328
Shifting the paradigm of type 1 diabetes: a narrative review of disease modifying therapies.
O'Donovan AJ, Gorelik S, Nally LM. · · 2024 · cited 4× · PMID 39568817 · DOI 10.3389/fendo.2024.1477101
Emerging Concepts and Success Stories in Type 1 Diabetes Research: A Road Map for a Bright Future.
Mallone R, Sims E, Achenbach P, Mathieu C, et al · · 2025 · cited 3× · PMID 39446565 · DOI 10.2337/db24-0439
Verapamil and low-dose anti-mouse thymocyte globulin combination therapy stably reverses recent-onset type 1 diabetes in NOD mice by acting on the beta cell and immune axes.
Degroote L, Martens PJ, Viaene M, Heremans Y, et al · · 2025 · cited 2× · PMID 40650745 · DOI 10.1007/s00125-025-06490-8
How Do We Move Type 1 Diabetes Immunotherapies Forward During the Current COVID-19 Pandemic?
Haller MJ, Jacobsen LM, Posgai AL, Schatz DA. · · 2021 · cited 2× · PMID 33632743 · DOI 10.2337/dbi20-0045
Changes in the Prevalence of Diabetes Ketoacidosis at the Onset of Type 1 Diabetes in Polish Children: A Comparative Analysis Between Two 9-Year Periods-2006-2014 and 2015-2023.
Niechciał E, Bielecki M, Geppert A, Kokociński S, et al · · 2025 · PMID 40741228 · DOI 10.1155/pedi/8927409

Verify or expand the search:

Other trials of Antithymocyte Globulin

Trials testing the same drug.

NCT05323617 — Efficacy of Romiplostim in Treatment of SAA in Adults Previously Untreated With or Refractory to Immunosuppressive Thera · Phase 2 · withdrawn
NCT04778618 — Individualized Dose Study of ATG in Haploidentical Hematopoietic Stem Cell Transplantation · Phase 2 · unknown

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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) trials

Trials by the same sponsor.

NCT07313787 — Effects of Meal Macronutrients on Postprandial Lipids · Phase 2 · not yet recruiting
NCT07388537 — Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults · not yet recruiting
NCT05713799 — Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity · Phase 2 · not yet recruiting
NCT05722210 — Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant · not yet recruiting
NCT07191561 — Hepatic Lipid Metabolism-Alcohol Use Disorder · not yet 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 NCT04291703 (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 National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last refreshed: 25 September 2025

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/NCT04291703.

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