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A Study of Single or Repeated Doses of Glucagon in Participants With Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02806973
Recruitment Status : Completed
First Posted : June 21, 2016
Results First Posted : October 14, 2019
Last Update Posted : October 14, 2019
Sponsor:
Collaborator:
Locemia Solutions ULC
Information provided by (Responsible Party):
Eli Lilly and Company

Brief Summary:
This study will investigate how the body processes nasal glucagon (NG) and the effect of nasal glucagon on the body. The study is expected to last about 50 days for each participant. The study is open to adults with type 1 or type 2 diabetes and will last about 50 days.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus, Type 2 Drug: Nasal Glucagon Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: A Single Center, Randomized, 4-Period Study to Evaluate the Pharmacokinetics, Pharmacodynamics and Safety of Single or Repeated 3 mg Doses of Intranasally Administered Glucagon in Adults With Type 1 or Type 2 Diabetes
Study Start Date : January 2015
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Glucagon

Arm Intervention/treatment
Experimental: Nasal Glucagon (NG) - Treatment 1
One dose of 3 milligram (mg) NG administered in one of four study periods.
Drug: Nasal Glucagon
Administered intranasally.
Other Names:
  • AMG504-1
  • LY900018

Experimental: NG - Treatment 2
Two NG doses, 3 mg each dose, administered 15 minutes apart, in the same nostril, in one of four study periods.
Drug: Nasal Glucagon
Administered intranasally.
Other Names:
  • AMG504-1
  • LY900018

Experimental: NG - Treatment 3
Two NG doses, 3 mg each dose, administered 15 minutes apart, in opposite nostrils, in one of four study periods.
Drug: Nasal Glucagon
Administered intranasally.
Other Names:
  • AMG504-1
  • LY900018

Experimental: NG - Treatment 4
Two NG doses, 3 mg each dose, administered one immediately after the other, in opposite nostrils, in one of four study periods.
Drug: Nasal Glucagon
Administered intranasally.
Other Names:
  • AMG504-1
  • LY900018




Primary Outcome Measures :
  1. Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon [ Time Frame: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration ]
  2. PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon [ Time Frame: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration ]
  3. PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon [ Time Frame: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration ]
  4. Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours [ Time Frame: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration ]
  5. PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose [ Time Frame: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration ]
  6. PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax) [ Time Frame: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration ]

Other Outcome Measures:
  1. PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Glucagon [ Time Frame: -0.5, -0.25, 0.00, 0.08, 0.17, 0.33, 0.50, 0.75, 1.00, 1.25, 1.50, 1.75, 2.00, 2.50, 3.00 hours after glucagon administration ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female with a history of Type 1 or Type 2 insulin-using diabetes of at least 1 year duration (basal only, basal bolus, meal-time only, or twice a day pre-mixed insulin)
  • A female participant must meet one of the following criteria:

    • Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first administration of the study drug, during the study and for at least 30 days after the last dose of the study drug
    • Participant is of non-childbearing potential, defined as surgically sterile (i.e. has undergone complete hysterectomy, bilateral oophorectomy, or tubal ligation) or in a menopausal state (at least 1 year without menses)
  • Participant with a body mass index (BMI) greater than or equal to 18.50 kilograms per square meter (kg/m²) and below 35.00 kg/m²
  • Light-, non- or ex-smokers
  • In good general health with no conditions that could influence the outcome of the trial, and in the judgment of the Investigator is a good candidate for the study based on review of available medical history, physical examination and clinical laboratory evaluations

Exclusion Criteria:

  • Females who are pregnant, actively attempting to get pregnant, or are lactating
  • History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs
  • Presence of significant gastrointestinal, liver or kidney disease, or any other conditions known to interfere with the absorption, distribution, metabolism or excretion of drugs or known to potentiate or predispose to undesired effects
  • Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases
  • Known presence of rare hereditary problems of galactose and /or lactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
  • Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors
  • Nasal surgery in the previous 28 days before Day 1 of this study
  • Daily use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study
  • Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the participant, at the discretion of the Investigator and the Sponsor, in the previous 28 days before Day 1 of this study
  • Significant history of drug dependency or alcohol abuse
  • Any clinically significant illness in the previous 28 days before Day 1 of this study
  • Any history of tuberculosis and/or prophylaxis for tuberculosis
  • Positive urine screening of alcohol and/or drugs of abuse
  • Positive results to human immunodeficiency virus (HIV) Antigen/Antibody (Ag/Ab) Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or anti-Hepatitis C Virus (HCV (C)) tests
  • Concurrent participation or intention of participating in another clinical trial during this study
  • Participants who took an Investigational Product (in another clinical trial) in the previous 28 days before Day 1 of this study or who have already participated in this clinical study
  • Participants who donated 50 milliliters (mL) or more of blood in the previous 28 days before Day 1 of this study
  • Donation of 500 mL or more of blood (Canadian Blood Services, Hema-Quebec, clinical studies, etc.) in the previous 56 days before Day 1 of this study

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): NCT02806973


Locations
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Canada, Quebec
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mount-Royal, Quebec, Canada, H3P 3P1
Sponsors and Collaborators
Eli Lilly and Company
Locemia Solutions ULC
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
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02806973    
Other Study ID Numbers: 16428
I8R-MC-IGBG ( Other Identifier: Eli Lilly and Company )
AMG112 ( Other Identifier: Algorithme Pharma )
AGL-P5-310 ( Other Identifier: Algorithme Pharma )
First Posted: June 21, 2016    Key Record Dates
Results First Posted: October 14, 2019
Last Update Posted: October 14, 2019
Last Verified: June 2016
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Glucagon
Gastrointestinal Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs