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Trial · Interventional

TerminatedPhase 1Results postedRegistry data

A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes

NCTNCT02806960 (opens ClinicalTrials.gov in a new tab)Other id16493Other idI8R-MC-IGBHOther idAMG110Other idAMG-P4-459
Open at ClinicalTrials.govAsk about this trial

Overview

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

Canada

Start
Jun 2014
Primary completion
Jun 2014
Completion
Aug 2014
First posted
21 Jun 2016 (estimated)
Last update posted
13 Dec 2019
Conditions
Diabetes Mellitus, Type 1 · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 stopped early · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20142015
  1. Ph 1

    A Study of Single and Repeated Doses of Glucagon Administered to Participants With Diabetes

    NCT02806960

    Jun 2014 to Aug 2014

    Terminated

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 and the effect of nasal glucagon on the body. After an 8-hour overnight fast and 4 hours after the start of a low-carbohydrate breakfast, the study drug will be delivered into the participant's nostril(s) (intranasally) once or twice in each of four study periods. The study is open to adults with type 1 or type 2 diabetes and is expected to last about 50 days for each participant.

Interventions

  • Nasal GlucagonDrug

Arms4

  • Experimental

    Treatment 1

    Treatment 1, single nasal glucagon (NG) dose of 3 milligram (mg).

  • Experimental

    Treatment 2

    Treatment 2, NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.

  • Experimental

    Treatment 3

    Treatment 3, NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.

  • Experimental

    Treatment 4

    Treatment 4, NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.

Primary outcomes7

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 · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

    Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

    Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

    Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

  5. Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG)

    Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 hours post dose for each treatment

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

    Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

  7. PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)

    Time frame · Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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 outcome· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

GroupValue
Treatment 1not posted
Treatment 2not posted
Treatment 3not posted
Treatment 4not posted
Primary outcome· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

GroupValue
Treatment 1not posted
Treatment 2not posted
Treatment 3not posted
Treatment 4not posted
Primary outcome· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

GroupValue
Treatment 1not posted
Treatment 2not posted
Treatment 3not posted
Treatment 4not posted
Primary outcome· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

GroupValue
Treatment 1not posted
Treatment 2not posted
Treatment 3not posted
Treatment 4not posted
Primary outcome· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, and 1.5 hours post dose for each treatment

Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG)

GroupValue
Treatment 1not posted
Treatment 2not posted
Treatment 3not posted
Treatment 4not posted
Primary outcome· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

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

GroupValue
Treatment 1not posted
Treatment 2not posted
Treatment 3not posted
Treatment 4not posted
Primary outcome· Day 1: -0.5, -0.25, 0, 0.08, 0.17, 0.33, 0.5, 0.75, 1.0, 1.25, 1.5, 1.75, 2, 2.5, and 3 hours post dose for each treatment

PD: Baseline-Adjusted Glucose Maximum Concentration (BGmax)

GroupValue
Treatment 1not posted
Treatment 2not posted
Treatment 3not posted
Treatment 4not posted

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Treatment 1Single NG dose of 3 mg.–0 / 32 / 3
Treatment 2NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.–0 / 32 / 3
Treatment 3NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.–0 / 33 / 3
Treatment 4NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.–0 / 33 / 3

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: * Males or females 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) * Participants 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 which in the judgment of the Investigator could interfere with the absorption, distribution, metabolism or excretion of drugs, or could 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 * Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) 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 * 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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