NCT03400501 is a EARLY_PHASE1 clinical trial of Insulin Degludec in Type 1 Diabetes Mellitus, sponsored by Yale University.

Who is sponsoring NCT03400501?

NCT03400501 is sponsored by Yale University.

What drugs are being tested in NCT03400501?

Interventions in NCT03400501: Insulin Degludec, Insulin Glargine.

What condition does NCT03400501 study?

NCT03400501 studies Type 1 Diabetes Mellitus.

Is NCT03400501 still recruiting?

NCT03400501 is currently completed. Last updated 5 November 2021.

Last reviewed 2021-11-05 · How we verify

NCT03400501

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

Reducing the Risk of Metabolic Decompensation in Diabetic Adolescents by Supervised School Administration of Insulin

Completed EARLY_PHASE1 Last updated 5 November 2021

What this trial tests

EARLY_PHASE1 trial testing Insulin Degludec in Type 1 Diabetes Mellitus in 32 participants. Completed in 7 June 2021.

Timeline

1 October 2017

Primary endpoint
7 June 2021

7 June 2021

Quick facts

Lead sponsor	Yale University
Phase	EARLY_PHASE1
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	32
Start date	1 October 2017
Primary completion	7 June 2021
Estimated completion	7 June 2021
Sites	1 location across United States

Drugs / interventions tested

Insulin Degludec (INSULIN DEGLUDEC) — full drug profile →
Insulin Glargine (INSULIN GLARGINE) — full drug profile →

Conditions studied

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

Sponsor

Yale University

Who can join

Adults 8 to 18, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This is a pilot study to examine and compare the efficacy of supervised injections of long acting insulins degludec and glargine to protect youth with poorly controlled type 1 diabetes (T1D) from development of ketones.

Publications & conference data

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

Pharmacologic treatment options for type 1 diabetes: what's new?
Nally LM, Sherr JL, Van Name MA, Patel AD, et al · · 2019 · cited 13× · PMID 30892094 · DOI 10.1080/17512433.2019.1597705
Impact of school-supervised ultra-long-acting basal insulin injections on ketosis in youth with T1D and elevated haemoglobin A1c: A pilot study.
Nally LM, Sherr JL, Tichy E, Weyman K, et al · · 2023 · cited 5× · PMID 37078999 · DOI 10.1111/dme.15123
Insulin Glargine in Type 1 Diabetes Mellitus: A Review of Clinical Trials and Real-world Evidence Across Two Decades.
Saboo B, Chandalia H, Ghosh S, Kesavadev J, et al · · 2024 · cited 4× · PMID 36896906 · DOI 10.2174/1573399819666230310150905

Verify or expand the search:

Other trials of Insulin Degludec

Trials testing the same drug.

NCT06178874 — Insulin Degludec vs Insulin Glargine for Glycemic Control in Critical Illness Hyperglycemia · NA · completed
NCT06202079 — A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mel · Phase 2 · completed
NCT06553248 — A Trial Investigating the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of GZR4 in Subjects With Type 2 Di · Phase 1 · completed
NCT06556641 — A Clinical Study of GZR33 and GZR101 in Healthy Subjects · Phase 1 · completed
NCT05463744 — A Study of Insulin Efsitora Alfa (LY3209590) Compared With Insulin Degludec in Participants With Type 1 Diabetes Treated · Phase 3 · completed

Other recruiting trials for Type 1 Diabetes Mellitus

Currently open trials in the same condition.

NCT07142252 — Rezpegaldesleukin (NKTR-358) in New Onset Type 1 Diabetes Mellitus · Phase 2 · recruiting
NCT07296276 — Accuracy and Precision of the Continuous Glucose Monitoring System 'CareSens Air 3' in Adult Patients With T1DM · NA · recruiting
NCT07409701 — Gamification Intervertion in Children With Type 1 Diabetes · NA · recruiting
NCT07356089 — Twiist Postmarket Surveillance Study for Type 1 Diabetes · recruiting
NCT07434154 — Evaluation of Oxidative Stress: Comparison Between Type 1 Diabetes Mellitus and Latent Autoimmune Diabetes in Adults · recruiting

Other Yale University trials

Trials by the same sponsor.

NCT06900998 — Pilot Study: Effects of Nimodipine on Alcohol Drinking · Phase 2 · not yet recruiting
NCT04910984 — Developing a Chatbot to Promote HIV Testing · NA · not yet recruiting
NCT07458087 — Accuracy of the Accuro 3S · NA · not yet recruiting
NCT07398404 — A Multiple Health Behavior Change (MHBC) Intervention for Weight Loss and Smoking Cessation for Pre-Bariatric Surgery Pa · Phase 1, PHASE2 · not yet recruiting
NCT07305324 — Improving Liver Fibrosis Diagnosis in Primary Care Using FibroX AI · NA · 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 NCT03400501 (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 Yale University
Last refreshed: 5 November 2021

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/NCT03400501.

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