severe hypoglycemia
Conditions
Interventions
Trade Name: Baqsimi
Product Name: Baqsimi (nasal glucagon)
Pharmaceutical Form: Nasal powder in single-dose container
Sponsors
Eli Lilly and Company
Eligibility
Sex/Gender
All
Inclusion 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 Are the trial subjects under 18? yes Number of subjects for this age range: 6 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range 0 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the safety and tolerability of a single dose of NG 3 mg in children aged 1 to <4 years with T1D ;Secondary Objective: To assess the PD of a single dose of NG 3 mg in children aged 1 to <4 years with T1D; To assess the PK of a single dose of NG 3 mg in children aged 1 to <4 years with T1D ;Primary end point(s): 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 [ Time Frame: Baseline through Day 9 ] A summary of SAEs, TEAEs and other non-serious adverse events (AEs), regardless of causality, will be reported in the Reported Adverse Events module ;Timepoint(s) of evaluation of this end point: [ Time Frame: Baseline through Day 9 ] | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacodynamics (PD): Change From Baseline (Predose Blood Glucose) in Maximum Observed Blood Glucose (BGmax) of Nasal Glucagon [Time Frame: Predose through Day 1 ] PD: Change From Baseline (Predose Blood Glucose) in BGmax of Nasal Glucagon PD: Absolute BGmax of Nasal Glucagon [ Time Frame: Predose through Day 1 ] PD: Absolute BGmax of Nasal Glucagon PD: Time of Maximum Observed Blood Glucose (TBGmax) of Nasal Glucagon [ Time Frame: Predose through Day 1 ] PD: TBGmax of Nasal Glucagon PD: Area Under the Concentration Versus Time Curve (AUC) of Blood Glucose [ Time Frame: Predose through Day 1 ] PD: AUC of Blood Glucose Pharmacokinetics (PK): AUC of Nasal Glucagon [ Time Frame: Predose through Day 1 ] PK: AUC of Nasal Glucagon ;Timepoint(s) of evaluation of this end point: [Time Frame: Predose through Day 1 ] | — |
Countries
United States
Contacts
Public ContactClinical Trial Registry Office
Eli Lilly and Company
Outcome results
None listed