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Trial · Interventional

CompletedPhase 1Results postedRegistry data

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

NCTNCT02806973 (opens ClinicalTrials.gov in a new tab)Other id16428Other idI8R-MC-IGBGOther idAMG112Other idAGL-P5-310

Overview

Status
Completed
Phase
Phase 1
Enrollment
32 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Single masking
Countries
1 country

Canada

Start
Jan 2015
Primary completion
Apr 2015
Completion
Apr 2015
First posted
21 Jun 2016 (estimated)
Last update posted
14 Oct 2019
Conditions
Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20152016
  1. Ph 1

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

    NCT02806973

    Jan 2015 to Apr 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Nasal GlucagonDrug

Arms4

  • Experimental

    Nasal Glucagon (NG) - Treatment 1

    One dose of 3 milligram (mg) NG administered in one of four study periods.

  • 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.

  • Experimental

    NG - Treatment 3

    Two NG doses, 3 mg each dose, administered 15 minutes apart, in opposite nostrils, in one of four study periods.

  • 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.

Primary outcomes6

Outcomes the sponsor listed as primary.

  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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMean· -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

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T(AUC[0-tlast]) of Baseline-Adjusted Glucagon

GroupValue (picogram*hour per millilitre (pg*hr/mL))Spread
Nasal Glucagon Treatment 124701850
Nasal Glucagon - Treatment 241001760
Nasal Glucagon - Treatment 346402400
Nasal Glucagon - Treatment 436101880
Primary outcomeMedian· -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

PK: Time to Maximum Concentration (Tmax) of Baseline Adjusted Glucagon

GroupValue (Hour (hr))
Nasal Glucagon Treatment 10.17
Nasal Glucagon - Treatment 20.33
Nasal Glucagon - Treatment 30.50
Nasal Glucagon - Treatment 40.33
Primary outcomeMean· -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

PK: Maximum Change From Baseline Concentration (Cmax) of Glucagon

GroupValue (picograms per millilitre (pg/mL))Spread
Nasal Glucagon Treatment 149603700
Nasal Glucagon - Treatment 271403270
Nasal Glucagon - Treatment 380804170
Nasal Glucagon - Treatment 466503640
Primary outcomeMean· -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

Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC0-3) of Baseline-Adjusted Glucose From Time Zero up to 3 Hours

GroupValue (Hour*millimoles per liter(hr*mmol/L))Spread
Nasal Glucagon Treatment 115795.7
Nasal Glucagon - Treatment 216899.3
Nasal Glucagon - Treatment 319095.3
Nasal Glucagon - Treatment 4194117
Primary outcomeMedian· -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

PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose

GroupValue (Hour (hr))
Nasal Glucagon Treatment 10.75
Nasal Glucagon - Treatment 21.00
Nasal Glucagon - Treatment 31.00
Nasal Glucagon - Treatment 41.00
Primary outcomeMean· -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

PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)

GroupValue (mmol/L)Spread
Nasal Glucagon Treatment 189.536.6
Nasal Glucagon - Treatment 298.439.4
Nasal Glucagon - Treatment 310836.9
Nasal Glucagon - Treatment 410544
Secondary and other outcome results(1)
Other pre specified outcomeMean· -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

PK: Area Under the Curve Extrapolated to Infinity (AUC[0-inf]) of Glucagon

GroupValue (pg*hr/mL)Spread
Nasal Glucagon Treatment 127301860
Nasal Glucagon - Treatment 244401800
Nasal Glucagon - Treatment 349402400
Nasal Glucagon - Treatment 439001920

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Nasal Glucagon Treatment 1One dose of nasal glucagon.–0 / 2727 / 27
Nasal Glucagon - Treatment 2Two doses of nasal glucagon, 15 minutes apart, in the same nostril.–0 / 2828 / 28
Nasal Glucagon - Treatment 3Two doses of nasal glucagon, 15 minutes apart, in opposite nostrils.–0 / 2525 / 25
Nasal Glucagon - Treatment 4Two doses of nasal glucagon, one immediately after the other, in opposite nostrils.–1 / 2927 / 29

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 70 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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