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A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
Plain-language guide to NCT03421379: phase 3 randomized trial of Glucagon, 75 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT03421379
- Phase
- phase 3
- Status
- completed
- Start
- 2018-02-21
- Completion (planned or actual)
- 2018-08-20
- Participants
- 75 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Glucagon.
It had two arms (groups): Glucagon Nasal Powder (experimental) and Glucagon Hydrochloride Solution (active comparator).
The registry classes the interventions as drug.
Who Took Part
75 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D). Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D.
The full record lists 3 inclusion and 2 exclusion criteria.
How the Study Was Run
It was run as a randomized, crossover and open-label study.
Random assignment meant chance, not the researchers, decided who got Glucagon and who got the comparison, which limits bias.
Each person switched between Glucagon and the comparison at some point, usually with a gap in between.
Nothing was hidden in this open-label Glucagon study: the participants and staff both knew the treatment.
It started in 2018-02-21 with completion listed for 2018-08-20.
It ran at 4 sites in Japan (4).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia.
It also tracked 5 secondary outcomes, for example PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM, PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM and PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Glucagon in 75 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Glucagon compound page, all human trials.
Our Notes on the Compound
Glucagon: A 29-amino-acid pancreatic hormone that raises blood glucose; used as a rescue medicine for severe low blood sugar and as a diagnostic aid.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.