A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Nasal Glucagon; Drug: Glucagon

• Registration Number: NCT02778113
• Lead Sponsor: Eli Lilly and Company

Brief Summary

The main purpose of this study was to evaluate the safety and tolerability of nasal glucagon (NG). The study drug was delivered into the participant's nostril (intranasally) or was given as an injection just under the skin (subcutaneously) once in each of four study periods. The study lasted about 23 days for each participant.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2016-05
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-18
• Study First Posted: 2016-05-19
• Results First Submitted: 2019-08-14
• Results First Submitted QC: 2019-08-14
• Last Update Submitted: 2019-08-14
• Results First Posted: 2019-09-19
• Last Update Posted: 2019-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Body mass index (BMI) greater than or equal to 20.00 and below or equal to 28.00 kg/m².
• Light-, non- or ex-smokers.
• Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination and/or clinical laboratory evaluations (hematology, biochemistry, ECG and urinalysis).

Read More

Exclusion Criteria

• Presence of any nose piercings.
• History of significant hypersensitivity to glucagon or any related products (including excipients of the formulations) as well as severe hypersensitivity reactions (like angioedema) to any drugs.
• Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects.
• Presence of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease.
• Presence of clinically significant findings on nasal examination and bilateral anterior rhinoscopy.
• Fasting blood glucose above 5.0 millimoles per liter (mmol/L) at screening, following a 12-hour fasting period.
• Fasting blood glucose assessed with a glucose meter above 5.5 mmol/L 0.5 hour before each dosing.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
NG - 2.0 mg	Nasal Glucagon	Ng dose at 2.0 milligram (mg) administered once in one of four study periods.
NG - 1.0 mg	Nasal Glucagon	Ng dose at 1.0 milligram (mg) administered once in one of four study periods.
Nasal Glucagon (NG) - 0.5 mg	Nasal Glucagon	Ng dose at 0.5 milligram (mg) administered once in one of four study periods.
SC Glucagon 1 mg	Glucagon	Subcutaneous (SC) glucagon dose of 1 mg, in one of four study periods.

Primary Outcome Measures

Name	Time	Method
Number of Participants With One or More Serious Adverse Event(s) (SAEs)	Baseline through Study Completion (Day 23)	Safety and tolerability evaluated through the assessment of adverse events. A SAE (serious adverse event) was defined as any untoward medical occurrence in a clinical investigation, which did not necessarily have a causal relationship with this treatment.; A summary of other non-serious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Secondary Outcome Measures

Name	Time	Method
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon	Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Baseline Adjusted Glucagon	Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon	Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon	Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₄) of Glucose	Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose	Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment
PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)	Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.25, 0.33, 0.5, 0.67, 1.0, 1.5, 2, 2.5, 3 and 4 hours post dose for each treatment

Trial Locations

Locations (1)

For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.; 🇨🇦 Mount-Royal, Quebec, Canada