Study version 1 · Published 2026-09-20

NCT03339453: preserved study context

This version preserves its selected source observations and article-review references. Open the current study collection →

Diabetes · Phase 1

Glucagon: nasal and injected formulations

NCT03339453 ↗

Glucagon

What was tested?

Nasal versus intramuscular glucagon during controlled insulin-induced hypoglycemia in adults with type 1 diabetes. ↗

Registered primary question: The proportion meeting the prespecified glucose-recovery criterion within 30 minutes after administration, without additional intervention. ↗

What the reviewed report found

Journal year 2020 · Article summary reviewed 2026-09-20

Both formulations achieved treatment success in all 66 evaluable participants within 25 minutes. Mean time to success was 11.4 minutes with nasal and 9.9 minutes with intramuscular glucagon.↗

Keep in context: This was a crossover comparison under controlled clinical conditions. Its primary efficacy analysis and safety population differ, and it did not test caregiver performance in an emergency. ↗↗

What a closer reading adds

Selected full-text sections checked 2026-09-20. These notes add context to the earlier article summary; they are not a complete risk-of-bias assessment.

The success rate uses an evaluable subset

The full text reports 70 treated participants and 69 who completed both periods. The primary efficacy analysis included 66: three did not meet the low-glucose criterion at one visit, and one withdrew after a single visit. The reported complete success rate refers to the evaluable analysis. Full text ↗ · Indexed abstract ↗

Sections: Demographics and Disposition; Efficacy.

Laboratory timing is not emergency performance

The authors note that time to glucose recovery excluded preparation of the injected comparator. Treatment was evaluated in a controlled clinical setting, and the study did not measure ease of use. Its timing results cannot establish performance during an emergency managed by a non-clinician. Full text ↗ · Indexed abstract ↗

Sections: Discussion.

Participants, design, limitations and sources

Registry snapshot

Registry enrollment
70 · reported actual
Registry status
Completed
Allocation and masking
Randomized · Open label
Design
Crossover
Eligible ages
18 Years to 64 Years
Registry results
Posted in this snapshot

Registry source ↗ · Updated 2019-09-23; retrieved 2026-09-20. Registry enrollment is not necessarily the analyzed sample in a publication. Posted registry results and published article results are separate.

Nasal versus intramuscular glucagon

Design in the report
Randomized crossover noninferiority study after experimentally induced hypoglycemia.↗
Participants in the report
The primary efficacy analysis included 66 adults with type 1 diabetes who received both formulations.↗
Limitations
The induced-hypoglycemia setting and controlled administration differ from an unplanned emergency. Recovery speed is distinct from preparation time and caregiver usability.↗

This reading covers the article abstract and record metadata. Read its preserved Human Evidence Review →

How the study identity and sources were checked

Study context checked 2026-09-20. Existing article summaries keep their original review dates. This is a selected study reading, not a complete literature or full-text appraisal.

Registry

A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus ↗
Protocol identifier: 16547. Sponsor: Eli Lilly and Company.
Retrieved 2026-09-20; SHA-256 fde781b67a74b4841a6509a1f92dbf7f453a44c79472e0d5293ae8ebf0e3ba0d.

PMID 32514794

Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. ↗

Exact trial identity is declared in PubMed’s ClinicalTrials.gov databank field. The registry independently labels this reference DERIVED. These source labels do not establish that every result in a paper applies to this trial.

Identity metadata retrieved 2026-09-20. EFetch XML; locate MedlineCitation/PMID 32514794. SHA-256 186f030ee2c6f571989d2f1d7f6b548a3397d13a4a1fae43dcaa660f3514315c.

Scientific summary uses the original 2026-09-20 source snapshot: SHA-256 186f030ee2c6f571989d2f1d7f6b548a3397d13a4a1fae43dcaa660f3514315c.

Selected full text: PMC7324463

Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study ↗

Retrieved 2026-09-20; SHA-256 613f1e42568902583950d2c770c4f35e0aadad13e63a1a2dd7aa1aa631f7575b. Section identifiers and hashes are included in the cited study data.