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

Phase 1

Completed

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).

Recruitment & 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

Arm && Interventions

Group	Intervention	Description
Nasal Glucagon	Nasal Glucagon	Single dose of Nasal Glucagon.
Intramuscular Glucagon	Intramuscular Glucagon	Single intramuscular (IM) dose of Glucagon.

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia	Pre-dose up to 30 minutes post each glucagon administration	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

Name	Time	Method
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
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
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
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
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

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, 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST) or speak with your personal physician.
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Neuss, Germany

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