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

NCT03339453 | Completed Phase 1 Results FDA Drug

• 3 other identifiers: 16547I8R-MC-IGBI2017-000249-33
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 2

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).

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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

• 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

• 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

Study Arms (2)

Nasal Glucagon

EXPERIMENTAL

Single dose of Nasal Glucagon.

Drug: Nasal Glucagon

Intramuscular Glucagon

ACTIVE COMPARATOR

Single intramuscular (IM) dose of Glucagon.

Drug: Intramuscular Glucagon

Interventions

Nasal Glucagon DRUG

Administered nasally

Also known as: LY900018

Nasal Glucagon

Intramuscular Glucagon DRUG

Administered IM

Also known as: GlucaGen®

Intramuscular Glucagon

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Diagnosis of Type 1 Diabetes Mellitus (T1DM) for at least 2 years and receiving daily insulin since the time of diagnosis

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (2)

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, 55116, Germany

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.

Neuss, Germany

Location

Related Publications (2)

• Seaquist E, Gimenez M, Yan Y, Matsuhisa M, Kao CY, Wadwa RP, Nagai Y, Khunti K. Nasal Glucagon Reverses Insulin-induced Hypoglycemia With Less Rebound Hyperglycemia: Pooled Analysis of Clinical Trials. J Endocr Soc. 2024 Feb 26;8(4):bvae034. doi: 10.1210/jendso/bvae034. eCollection 2024 Feb 19.

  PMID: 38444629 DERIVED

• 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.

  PMID: 32514794 DERIVED

MeSH Terms

Conditions

Hypoglycemia; Diabetes Mellitus, Type 1

Interventions

Glucagon-Like Peptide 1

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 13, 2017
• Study Start: November 10, 2017
• Primary Completion: December 17, 2017
• Study Completion: January 13, 2018
• Last Updated: September 23, 2019
• Results First Posted: September 23, 2019

Record last verified: 2018-01

Locations

DE (2)