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A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (RescuiNGkids)

Primary Purpose

Type 1 Diabetes

Status

Recruiting

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Glucagon Nasal Powder [Baqsimi]

About this trial

This is an interventional basic science trial for Type 1 Diabetes focused on measuring Severe Hypoglycemia, Nasal Powder, Hypoglycemia Rescue Therapy, Ready to use Glucagon

Eligibility Criteria

1 Year - 4 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Have a Type 1 Diabetes diagnosis for at least 6 months
Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening
Have a HbA1c level of ≤ 9.5% at screening
Have sufficient venous access for collection of blood samples
Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly

Exclusion Criteria:

Have a presence or history of glucagon hypersensitivity
Have a history of pheochromocytoma
Have a history of epilepsy or seizure disorder
Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose
Are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit
Have an episode of severe hypoglycemia or have had glucagon administered , during the 3 months prior to the screening visit and no severe hypoglycemia between the screening and dosing visit

Sites / Locations

Nemours Childrens Clinic
St. Luke's Regional Medical CenterRecruiting
Riley Hospital for Children
University of Minnesota Medical SchoolRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glucagon Nasal Powder

Arm Description

A single dose of glucagon nasal powder administered intranasally.

Outcomes

Primary Outcome Measures

Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Secondary Outcome Measures

Pharmacodynamics (PD): Change From Baseline (Predose Blood Glucose) in Maximum Observed Blood Glucose (BGmax) of Nasal Glucagon

PD: Change From Baseline (Predose Blood Glucose) in BGmax of Nasal Glucagon

PD: Absolute BGmax of Nasal Glucagon

PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon

PD: TBGmax of Nasal Glucagon

PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose

PD: AUC of Blood Glucose

Pharmacokinetics (PK): AUC of Nasal Glucagon

PK: AUC of Nasal Glucagon

Full Information

NCT ID

NCT04992312

First Posted

August 4, 2021

Last Updated

October 17, 2023

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT04992312

Brief Title

A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes

Acronym

RescuiNGkids

Official Title

An Open-Label, Multi-Center, Single-Dose Study to Assess the Safety, Tolerability, Pharmacodynamics, and Pharmacokinetics of Nasal Glucagon in Pediatric Patients With Type 1 Diabetes Aged 1 to <4 Years

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

March 24, 2022 (Actual)

Primary Completion Date

December 18, 2023 (Anticipated)

Study Completion Date

December 18, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D) aged 1 to less than 4 years. Blood tests will be performed to check how much nasal glucagon gets into the bloodstream. Blood sugar will also be measured to understand the effect of the drug on blood sugar levels. The study consists of a screening period up to 35 days before dosing, 1 day when a dose of nasal glucagon will be given and then 2 telephone follow up calls; first follow-up call on the day after the nasal glucagon was given and second call about one week after nasal glucagon was given. The study will last up to 9 days, not including the screening period.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Severe Hypoglycemia, Nasal Powder, Hypoglycemia Rescue Therapy, Ready to use Glucagon

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Glucagon Nasal Powder

Arm Type

Experimental

Arm Description

A single dose of glucagon nasal powder administered intranasally.

Intervention Type

Drug

Intervention Name(s)

Glucagon Nasal Powder [Baqsimi]

Other Intervention Name(s)

LY900018, Baqsimi

Intervention Description

Administered intranasally

Primary Outcome Measure Information:

Title

Number of Participants with One or More Treatment-Emergent Adverse Event(s) (TEAEs) and Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug Administration

Description

A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module

Time Frame

Baseline through Day 9

Secondary Outcome Measure Information:

Title

Pharmacodynamics (PD): Change From Baseline (Predose Blood Glucose) in Maximum Observed Blood Glucose (BGmax) of Nasal Glucagon

Description

PD: Change From Baseline (Predose Blood Glucose) in BGmax of Nasal Glucagon

Time Frame

Predose through Day 1

Title

PD: Absolute BGmax of Nasal Glucagon

Description

PD: Absolute BGmax of Nasal Glucagon

Time Frame

Predose through Day 1

Title

PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon

Description

PD: TBGmax of Nasal Glucagon

Time Frame

Predose through Day 1

Title

PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose

Description

PD: AUC of Blood Glucose

Time Frame

Predose through Day 1

Title

Pharmacokinetics (PK): AUC of Nasal Glucagon

Description

PK: AUC of Nasal Glucagon

Time Frame

Predose through Day 1

10. Eligibility

Sex

All

Minimum Age & Unit of Time

1 Year

Maximum Age & Unit of Time

4 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Have a Type 1 Diabetes diagnosis for at least 6 months Have been receiving insulin therapy via multiple daily injections or using an insulin pump and have been stable for at least 3 months prior to screening Have a HbA1c level of ≤ 9.5% at screening Have sufficient venous access for collection of blood samples Have good general health, apart from their Type 1 diabetes, with no prior history of choanal atresia, nasal/pharyngeal blockage or nasal anomaly Exclusion Criteria: Have a presence or history of glucagon hypersensitivity Have a history of pheochromocytoma Have a history of epilepsy or seizure disorder Have 1 or more congenital anomalies to the anatomy of the nose, or require changes to the anatomy of the nose Are using closed-loop insulin therapy, unless such a device is set to 'open loop/manual' mode on the day of the dosing visit Have an episode of severe hypoglycemia or have had glucagon administered , during the 3 months prior to the screening visit and no severe hypoglycemia between the screening and dosing visit

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Phone

1-317-615-4559

ClinicalTrials.gov@Lilly.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Nemours Childrens Clinic

City

Jacksonville

State/Province

Florida

ZIP/Postal Code

32207

Country

United States

Individual Site Status

Completed

Facility Name

St. Luke's Regional Medical Center

City

Boise

State/Province

Idaho

ZIP/Postal Code

83712

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

208-381-7340

First Name & Middle Initial & Last Name & Degree

Daniel Flynn

Facility Name

Riley Hospital for Children

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Completed

Facility Name

University of Minnesota Medical School

City

Minneapolis

State/Province

Minnesota

ZIP/Postal Code

55454

Country

United States

Individual Site Status

Recruiting

Facility Contact:

Phone

612-625-6738

First Name & Middle Initial & Last Name & Degree

Brandon Nathan

12. IPD Sharing Statement

Plan to Share IPD

Links:

URL

https://trials.lillytrialguide.com/en-US/trial/3M5oZzkbDqRlSiqf7KNpeL

Description

A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes (RescuiNGkids)

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A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes

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