Phase 3
Completed N=75
A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
Source: ClinicalTrials.gov NCT03421379 ↗Enrolled (actual)
75
Serious AEs
0.7%
Results posted
Oct 2019
Primary outcomePrimary: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia — 100; 100 percentage of participants
◆ Published Evidence
Emerging
2citations · ~1 / year
Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.
Summary
The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.
Linked Publications
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Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia |
100; 100 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM) |
113; 119 | — |
| SECONDARY PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM |
1.00; 1.50 | — |
| SECONDARY Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM |
4830; 3240 | — |
| SECONDARY PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM |
9520; 3290 | — |
| SECONDARY PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM |
0.25; 0.17 | — |
Eligibility Criteria
Inclusion Criteria
- 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
- Hemoglobin A1c (HbA1c) ≤10%
Exclusion Criteria
- Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
- Have received a total daily dose of insulin >1.2 units per kilogram (U/kg)
Data sourced from ClinicalTrials.gov (NCT03421379) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.