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

25. november 2019 opdateret af: Eli Lilly and Company

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

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.

Studieoversigt

Status

Afsluttet

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

12

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Quebec
      • Mount-Royal, Quebec, Canada, H3P 3P1
        • 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.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 70 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Grundvidenskab
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Treatment 1
Treatment 1, single nasal glucagon (NG) dose of 3 milligram (mg).
Indgives intranasalt.
Andre navne:
  • LY900018
  • AMG 504-1
Eksperimentel: Treatment 2
Treatment 2, NG dose of 3 mg plus 3 mg NG dose in same nostril 15 minutes later.
Indgives intranasalt.
Andre navne:
  • LY900018
  • AMG 504-1
Eksperimentel: Treatment 3
Treatment 3, NG dose of 3 mg plus 3 mg NG dose in the opposite nostril 15 minutes later.
Indgives intranasalt.
Andre navne:
  • LY900018
  • AMG 504-1
Eksperimentel: Treatment 4
Treatment 4, NG dose of 3 mg then immediately 3 mg NG dose in the opposite nostril.
Indgives intranasalt.
Andre navne:
  • LY900018
  • AMG 504-1

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time Zero to T (AUC[0-tlast]) of Baseline Adjusted Glucagon
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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
Tidsramme: 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
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
Pharmacodynamics (PD): Area Under the Effect Concentration Time Curve (AUEC₀-₁.₅) of Blood Glucose (BG)
Tidsramme: 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
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
PD: Time to Maximum Concentration (Tmax) of Baseline-Adjusted Glucose
Tidsramme: 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
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)
Tidsramme: 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
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Samarbejdspartnere

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. juni 2014

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. august 2014

Datoer for studieregistrering

Først indsendt

26. maj 2016

Først indsendt, der opfyldte QC-kriterier

17. juni 2016

Først opslået (Skøn)

21. juni 2016

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. december 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

25. november 2019

Sidst verificeret

1. november 2019

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 16493
  • I8R-MC-IGBH (Anden identifikator: Eli Lilly and Company)
  • AMG110 (Anden identifikator: AMG Medical Inc)
  • AMG-P4-459 (Anden identifikator: AMG Medical Inc)

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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