Phase 1
Completed N=70
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
Hypoglycemia · Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT03339453 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia — 66; 66 Participants
Summary
The purpose of this study is to compare a needle-free treatment of hypoglycemia with nasal glucagon (study drug) to a marketed glucagon administered by the intramuscular (IM) route, in participants with type 1 diabetes mellitus (T1DM).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia |
66; 66 | — |
| SECONDARY Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) |
132; 161 | — |
| SECONDARY PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose |
1.00; 1.50 | — |
| SECONDARY Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon |
2740; 3320 | — |
| SECONDARY PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon |
6130; 3750 | — |
| SECONDARY PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon |
0.25; 0.25 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis
Exclusion Criteria
- Have a history of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
- Have a history of pheochromocytoma (that is, adrenal gland tumor) or insulinoma
- Occurrence of an episode of severe hypoglycemia (defined as requiring the assistance of another person in the 1 month prior to enrolling in the study)
- Have a history of epilepsy or seizure disorder
- Are women who are pregnant or lactating
- Have, except for the current regimen of insulin therapy and concomitant medication, regular use of or intended use of any over-the-counter or prescription medications or nutritional supplements that treat hyperglycemia or insulin resistance or that promote weight loss within 14 days before dosing
- Daily use of systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs
- Require daily insulin treatment greater than (>)1.5 unit/kilograms (U/kg)/body weight
Data sourced from ClinicalTrials.gov (NCT03339453). 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.