A Study Comparing User Experience of Different Delivery Devices for Glucagon

NCT03765502 | Completed Phase 1 Results FDA Device

• 2 other identifiers: 17156I8R-MC-IGBM
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to learn more about different devices for delivering glucagon during simulations of severe hypoglycemic (low blood sugar) emergencies. The study will be carried out using medical manikins to simulate real life scenarios. No drug will be administered to humans. Part A will last approximately 17 days for Trained Users and Participants with Diabetes (PWD). Part B will last approximately nine (9) days for Untrained Users. Each part will be separated by approximately 7 days.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• Percentage of Trained Users That Performed a Successful Administration for Each Device

  Percentage of trained users who found both devices and performed a successful administration of both rescue devices for both simulations.

  Part A: Days 8 - 9 and Days 15 - 17

Secondary Outcomes (6)

• Percentage of Untrained Users That Perform a Successful Administration for Each Device

  Part B: Day 1 and Days 8-9

• Average Time for Trained Users to Successfully Administer One Device Over the Other

  Part A: Day 8 and Days 15-17

• Average Time for Untrained Users to Successfully Administer One Device Over the Other

  Part B: Day 1 and Days 8-9

• Percentage of Participants (Trained and Untrained Users) That Prefer One Device Over the Other

  Part A: Days 8-9; Day 15-17 and Part B: Day 1; Days 8-9

• Percentage of Participants (PWD) That Prefer One Device Over the Other

  Part A: Days 15 - 17

Study Arms (2)

Nasal Glucagon Device (NG)

EXPERIMENTAL

Empty NG device administered to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.

Device: Nasal Glucagon Device (NG)

Glucagon Emergency Kit (GEK)

ACTIVE COMPARATOR

Commercially available GEK delivered intramuscularly to a manikin during simulations of severe hypoglycaemia emergencies. No drug will be administered to humans.

Device: GEK; Drug: IM Glucagon

Interventions

Nasal Glucagon Device (NG) DEVICE

NG devices will be provided empty of drug product

Nasal Glucagon Device (NG)

GEK DEVICE

Used to administer glucagon intramuscularly (IM)

Glucagon Emergency Kit (GEK)

IM Glucagon DRUG

Administered IM via GEK

Glucagon Emergency Kit (GEK)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All participants (Trained Users, Participants with Diabetes \[PWDs\] and Untrained Users):
• Are able to understand the purpose and procedure of the study and to give written informed consent to show willingness to participate in the study
• Trained Users only:
• Are participants who are not diagnosed with Type 1 Diabetes Mellitus (T1DM) or Type 2 Diabetes Mellitus (T2DM)
• Are close friends/relatives of a patient with T1DM or T2DM on insulin
• Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)
• Untrained Users only:
• Have not been diagnosed with T1DM or T2DM, and are not a Trained User of a person with T1DM or T2DM
• Have not previously administered any rescue medications (e.g. epinephrine, glucagon, narcan or seizure medications)

You may not qualify if:

• All participants (Trained Users, PWDs and Untrained Users):
• Trained Users and Untrained Users only (i.e. the participants involved in the simulations):
• Are currently enrolled in a clinical study involving any type of medical research judged not to be scientifically or medically compatible with this study
• Are judged by the investigator as being likely to have difficulty performing the administration due to physical, cognitive and/or severe psychiatric disorder
• Are judged by the investigator as being trained or experienced in performing rescue drug administration
• Are judged by the investigator as being trained or experienced in performing high-fidelity simulations of drug administration
• Have received formal training in a medical field, and/or worked in this field within the prior 5 years; or otherwise are judged by the investigator as being trained or experienced as a first responder

Sponsors & Collaborators

• Eli Lilly and Company: lead

Study Sites (1)

High Point Clinical Trials Center

High Point, North Carolina, 27265, United States

Location

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

ClinicalTrials.gov@lilly.com

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2018
• First Posted: December 5, 2018
• Study Start: November 19, 2018
• Primary Completion: January 3, 2019
• Study Completion: January 3, 2019
• Last Updated: March 20, 2020
• Results First Posted: March 20, 2020

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)