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

Diabetes Mellitus, Type 1 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03339453
• Other study ID #: 16547
• Secondary ID: I8R-MC-IGBI2017-
• Status: Completed
• Phase: Phase 1
• Start date: November 10, 2017
• Est. completion date: January 13, 2018

Study information

• Verified date: January 2018
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: January 13, 2018
• Est. primary completion date: December 17, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Drug:
• Nasal Glucagon
Administered nasally
• Intramuscular Glucagon
Administered IM

Locations

Country	Name	City	State
Germany	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.	Mainz
Germany	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.	Neuss

Sponsors (1)

Lead Sponsor	Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-dose up to 30 minutes post each glucagon administration
Secondary	Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax)		Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Secondary	PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose		Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, and 90 minutes after glucagon administration
Secondary	Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to Tlast (AUC[0-tlast]) of Baseline Adjusted Glucagon		Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Secondary	PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon		Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration
Secondary	PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon		Pre-dose; 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, and 240 minutes after glucagon administration