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A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus

Primary Purpose

Hypoglycemia, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
Nasal Glucagon
Intramuscular Glucagon
Sponsored by
Eli Lilly and Company
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hypoglycemia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Nasal Glucagon

Intramuscular Glucagon

Arm Description

Single dose of Nasal Glucagon.

Single intramuscular (IM) dose of Glucagon.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.

Secondary Outcome Measures

Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

Full Information

First Posted
November 8, 2017
Last Updated
August 16, 2019
Sponsor
Eli Lilly and Company
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1. Study Identification

Unique Protocol Identification Number
NCT03339453
Brief Title
A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus
Official Title
Comparison of Glucagon Administered by Either the Nasal (LY900018) or Intra-muscular (GlucaGen®) Routes in Adult Patients With Type 1 Diabetes Mellitus During Controlled Insulin-Induced Hypoglycemia
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
November 10, 2017 (Actual)
Primary Completion Date
December 17, 2017 (Actual)
Study Completion Date
January 13, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoglycemia, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Nasal Glucagon
Arm Type
Experimental
Arm Description
Single dose of Nasal Glucagon.
Arm Title
Intramuscular Glucagon
Arm Type
Active Comparator
Arm Description
Single intramuscular (IM) dose of Glucagon.
Intervention Type
Drug
Intervention Name(s)
Nasal Glucagon
Other Intervention Name(s)
LY900018
Intervention Description
Administered nasally
Intervention Type
Drug
Intervention Name(s)
Intramuscular Glucagon
Other Intervention Name(s)
GlucaGen®
Intervention Description
Administered IM
Primary Outcome Measure Information:
Title
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
Description
Treatment success is defined as an increase in plasma glucose to greater than or equal to (≥) 70 milligrams per deciliter (mg/dL) or an increase of ≥20 mg/dL from plasma glucose nadir, without receiving additional actions to increase the plasma glucose concentration. Nadir is defined as the minimum plasma glucose concentration at the time of or within 10 minutes following glucagon administration.
Time Frame
Pre-dose up to 30 minutes post each glucagon administration
Secondary Outcome Measure Information:
Title
Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)
Time Frame
Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Title
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Time Frame
Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Title
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon
Time Frame
Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Title
PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon
Time Frame
Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Title
PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon
Time Frame
Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Organizational Affiliation
Eli Lilly and Company
Official's Role
Study Director
Facility Information:
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Mainz
ZIP/Postal Code
55116
Country
Germany
Facility Name
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
City
Neuss
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
32514794
Citation
Suico JG, Hovelmann U, Zhang S, Shen T, Bergman B, Sherr J, Zijlstra E, Frier BM, Plum-Morschel L. Glucagon Administration by Nasal and Intramuscular Routes in Adults With Type 1 Diabetes During Insulin-Induced Hypoglycaemia: A Randomised, Open-Label, Crossover Study. Diabetes Ther. 2020 Jul;11(7):1591-1603. doi: 10.1007/s13300-020-00845-7. Epub 2020 Jun 8.
Results Reference
derived

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A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus

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