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Completed

NCT Number: NCT03339453

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

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).

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Key information

Conditions

Hypoglycemia Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nasal Glucagon

Drug

Administered nasally

Other names: LY900018

Intramuscular Glucagon

Drug

Administered IM

Other names: GlucaGen®

Primary outcomes

  1. Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia

    Time frame: 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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

Sponsors and collaborators

Lead sponsor

Eli Lilly and Company

Industry

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Nov 13, 2017
Registry last updated
Sep 23, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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