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

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ClinicalTrials.gov Identifier: NCT03339453
Recruitment Status : Completed
First Posted : November 13, 2017
Results First Posted : September 23, 2019
Last Update Posted : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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).

Condition or disease Intervention/treatment Phase
Hypoglycemia Diabetes Mellitus, Type 1 Drug: Nasal Glucagon Drug: Intramuscular Glucagon Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
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
Actual Study Start Date : November 10, 2017
Actual Primary Completion Date : December 17, 2017
Actual Study Completion Date : January 13, 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Nasal Glucagon
Single dose of Nasal Glucagon.
Drug: Nasal Glucagon
Administered nasally
Other Name: LY900018

Active Comparator: Intramuscular Glucagon
Single intramuscular (IM) dose of Glucagon.
Drug: Intramuscular Glucagon
Administered IM
Other Name: GlucaGen®




Primary Outcome Measures :
  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 Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03339453


Locations
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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, 55116
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, Germany
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: 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) Eli Lilly and Company
  Study Documents (Full-Text)

Documents provided by Eli Lilly and Company:
Study Protocol  [PDF] October 12, 2017
Statistical Analysis Plan  [PDF] September 22, 2017


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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT03339453     History of Changes
Other Study ID Numbers: 16547
I8R-MC-IGBI ( Other Identifier: Eli Lilly and Company )
2017-000249-33 ( EudraCT Number )
First Posted: November 13, 2017    Key Record Dates
Results First Posted: September 23, 2019
Last Update Posted: September 23, 2019
Last Verified: January 2018

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Glucagon-Like Peptide 1
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Incretins