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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Evaluate the Immunogenicity of a Novel Glucagon Formulation

NCTNCT01959334 (opens ClinicalTrials.gov in a new tab)Other id16426Other idI8R-MC-IGBFOther idAMG105

Overview

Status
Completed
Phase
Phase 3
Enrollment
75 participants (actual)
Sponsor
Eli Lilly and Company · Industry
Design
Randomized · Open label (no masking)
Countries
1 country

Canada

Start
Sept 2013
Primary completion
Dec 2013
Completion
Dec 2013
First posted
10 Oct 2013 (estimated)
Last update posted
6 Sept 2019
Conditions
Drug-specific Antibodies · Diabetes Mellitus

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20132014
  1. Ph 3

    Evaluate the Immunogenicity of a Novel Glucagon Formulation

    NCT01959334

    Sept 2013 to Dec 2013

Registry summary

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

This study provides information on immunogenicity of Nasal Glucagon (AMG504-1) with regards to the potential development of treatment-emergent anti-glucagon antibodies.

Interventions

  • Nasal Glucagon (NG)Drug
  • Glucagon IMDrug

Arms2

  • Active comparator

    Glucagon IM

    Glucagon dose of 1 milligram (mg) administered intramuscularly (IM).

  • Experimental

    Nasal Glucagon (NG

    Nasal Glucagon (NG) doses of 3 mg administered intra-nasally.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA)

    Time frame · Baseline through study completion (up to 10 weeks)

    Registry description

    Glucagon anti-drug antibodies (ADA) were assessed at baseline through study completion. Percentage of participants (Pts) with ADA=(number of Pts with treatment-emergent ADA/number of Pts assessed)\*100. Treatment-Emergent ADA includes treatment-induced ADA and treatment boosted ADA. Treatment-induced is defined as participants with 'Not Detected' ADA at baseline (drug-naive) and at least one post-baseline ADA 'Detected' sample with a corresponding titer that is one 2-fold dilution higher than the MRD (minimal required dilution) of the assay. For the nasal glucagon Tier 1-3 ADA screening assay, the MRD is 1:20. Treatment-boosted is defined as Patient with ADA 'Detected' at baseline (drug-naive) and at least one post-baseline ADA 'Detected' sample with a corresponding titer that is at least (\>or=) 4-fold higher than the baseline titer.

  2. Percentage of Participants With Neutralizing Antibodies

    Time frame · Baseline through study completion (up to 10 weeks)

  3. Number of Participants With At Least One Adverse Event

    Time frame · First dose of study drug through the post-study completion (up to 10 weeks)

    Registry description

    Safety parameters assessed included the occurrence of adverse events, the measurement of clinical laboratory parameters; vital signs, ECGs, physical examination, blood glucose, and examination of the injection site (following the IM administration). An AE was defined as any untoward medical occurrence in a clinical investigation subject administered the investigational product and which did not necessarily have a causal relationship with this treatment A summary of other nonserious AEs, and all SAE's, regardless of causality, is located in the Reported Adverse Events section.

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 outcomeNumber· Baseline through study completion (up to 10 weeks)

Percentage of Participants With Treatment-emergent Anti-Drug Antibody (ADA)

GroupValue (percentage of participants)
Glucagon IM0
Nasal Glucagon (NG)2.0
Primary outcomeNumber· Baseline through study completion (up to 10 weeks)

Percentage of Participants With Neutralizing Antibodies

GroupValue (percentage of participants)
Glucagon IM0
Nasal Glucagon (NG)0
Primary outcomeCount of participants· First dose of study drug through the post-study completion (up to 10 weeks)

Number of Participants With At Least One Adverse Event

GroupValue (Participants)
Glucagon IM21
Nasal Glucagon (NG)49

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Glucagon IMGlucagon dose of 1 mg administered intramuscularly as 3 doses separated by at least 7 days.–0 / 2621 / 26
Nasal Glucagon (NG)NG administered at 3 mg as 3 doses, separated by at least 7 days.–0 / 4949 / 49

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: 1. Availability for the entire study period 2. Motivated volunteer and absence of intellectual problems likely to limit the validity of consent to participate in the study or the compliance with protocol requirements; ability to cooperate adequately; ability to understand and observe the instructions of the physician or designee 3. Male or female patient with a history of Type 1 or Type 2 diabetes of at least 2 years duration 4. A female volunteer must meet one of the following criteria: 1. Participant is of childbearing potential and agrees to use one of the accepted contraceptive regimens throughout the entire duration of the study (from the screening visit until study completion). Additionally, if the participant is using systemic contraceptives, she must use an additional form of acceptable contraception. An acceptable method of contraception includes one of the following: * Abstinence from heterosexual intercourse * Systemic contraceptives (birth control pills, injectable/implant /insertable hormonal birth control products, transdermal patch) * Intrauterine device (with and without hormones) * Condom with spermicide or 2. 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) 5. Volunteer aged of at least 18 years but not older than 70 years 6. Volunteer with a BMI greater than or equal to 18.50 and below 35.00 kg/m2 7. Light-, non- or ex-smokers. A light smoker is defined as someone smoking 10 cigarettes or less per day for at least 3 months before day 1 of this study. An ex- smoker is defined as someone who completely stopped smoking for at least 6 months before day 1 of this study 8. 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 9. Willingness to adhere to the protocol requirements as evidenced by the informed consent form (ICF) duly read, signed and dated by the volunteer The informed consent form must be signed by all volunteers, prior to their participation in the study. Exclusion Criteria: 1. Females who are pregnant, actively attempting to get pregnant, or are lactating 2. History of significant hypersensitivity to glucagon or any related products as well as severe hypersensitivity reactions (such as angioedema) to any drugs 3. 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 4. Suicidal tendency, history of or disposition to seizures, state of confusion, clinically relevant psychiatric diseases 5. Known presence of rare hereditary problems of galactose and /or lactose intolerance 6. Known presence or history of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma (i.e. insulin secreting pancreas tumor) 7. Presence of clinically significant findings on nasal examination or bilateral anterior rhinoscopy, such as structural abnormalities, nasal polyps, marked septal deviation, nasal tumors 8. Nasal surgery in the previous 28 days before Day 1 of this study 9. Use of a systemic beta-blocker drug, indomethacin, warfarin or anticholinergic drugs in the previous 28 days before Day 1 of this study 10. Use of an immunomodulator medication (including steroids, glucocorticoids, tacrolimus, etc.) in the 28 days before day 1 of this study 11. Any other concomitant maintenance therapy that would influence the outcome of the trial or compromise the safety of the patient, at the discretion of the Investigator and the Sponsor, in the previous 28 days before day 1 of this study 12. Significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic) 13. Any clinically significant illness in the previous 28 days before day 1 of this study 14. Any history of tuberculosis and/or prophylaxis for tuberculosis 15. Positive urine screening of alcohol and/or drugs of abuse 16. Females who are pregnant according to a positive pregnancy test 17. Concurrent participation or intention of participating in another clinical trial during this study 18. Volunteers who took an Investigational Product (in another clinical trial) or donated 50 mL or more of blood in the previous 28 days before day 1 of this study 19. 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 No participants will be allowed to enroll in this study more than once (i.e. if the study is conducted with more than 1 group).

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