Clinical trial NCT03421379: A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus
Official title: A Phase 3 Study of Nasal Glucagon (LY900018) Compared to Intramuscular Glucagon for Treatment of Insulin-induced Hypoglycemia in Japanese Patients With Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2018-02-05
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the efficacy and safety of nasal glucagon compared to intramuscular (IM) glucagon for treatment of insulin-induced hypoglycemia in Japanese participants with diabetes mellitus.


Eligibility criteria: Inclusion Criteria:

* Participants with Type 1 diabetes (T1D) or Type 2 diabetes (T2D)
* Body mass Index (BMI) of 18.5 to 30.0 kilograms per meter squared (kg/m2) for T1D, or 18.5 to 35.0 kg/m2 for T2D
* Hemoglobin A1c (HbA1c) ≤10%

Exclusion Criteria:

* Have significant changes in insulin regimen and/ or unstable blood sugar control within the past 3 month
* Have received a total daily dose of insulin \>1.2 units per kilogram (U/kg)

Primary outcomes:
measure: Percentage of Participants Achieving Treatment Success During Controlled Insulin-Induced Hypoglycemia
timeFrame: Pre-dose up to 30 minutes post each glucagon administration
Secondary outcomes:
measure: Pharmacodynamics (PD): Change From Baseline in Maximal Blood Glucose (BGmax) of Glucagon Nasal Powder and Glucagon Hydrochloride Intramuscular (IM)
timeFrame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
measure: PD: Time to Maximal Concentration (Tmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
timeFrame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
measure: Pharmacokinetics (PK): Change From Baseline in Area Under the Concentration Versus Time Curve From Zero to Time t (AUC [0-tLast]) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
timeFrame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
measure: PK: Change From Baseline in Maximal Concentration (Cmax) of Glucagon Nasal Powder and Glucagon Hydrochloride IM
timeFrame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
measure: PK: Change From Baseline in Tmax of Glucagon Nasal Powder and Glucagon Hydrochloride IM
timeFrame: Pre-dose, 5, 10, 15, 20, 25, 30, 40, 50, 60, 90, 120, 240 minutes after each glucagon administration
Other outcomes:
Locations:
city: Fukuoka
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: 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.
city: Tokyo
country: Japan
facility: For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.
city: Tokyo
country: Japan
facility: 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.
Study officials:
affiliation: Eli Lilly and Company
name: 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)
role: STUDY_DIRECTOR
References: