Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults

Lilly

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Intramuscular Glucagon

Drug: Nasal Glucagon

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT01994746

INGluc001 (Other Identifier)

I8R-MC-IGBC (Other Identifier)

16422

AMG106 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to assess the efficacy, pharmacokinetics (PK), pharmacodynamics (PD), and safety of 3 milligrams (mg) glucagon (glucagon nasal powder) administered nasally compared with commercially available glucagon given by intramuscular injection.

Full description

Each glucagon dosing visit was conducted after an overnight fast of at least 8 h with a starting plasma glucose >= 90 mg/dL. Hypoglycemia was induced by an intravenous (IV) infusion of regular insulin diluted in normal saline during the clinic visit. Five minutes after stopping the insulin infusion (once the plasma glucose was <60 mg/dL), participants were treated with either a 3 mg glucagon dose nasally or 1 mg of glucagon administered by intramuscular (IM) injection.

After a wash-out period of 7 days or more, participants returned to the clinic and the procedure repeated with each participant crossed over to the other treatment. As such, each participant underwent two episodes of insulin-induced hypoglycemia in random order and received glucagon nasal powder during one episode and commercially available glucagon (GlucaGen, Novo Nordisk) by IM injection during the other episode.

Enrollment

77 patients

Sex

All

Ages

18 to 64 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

To be eligible, the following inclusion criteria must be met:

Clinical diagnosis of either type 1 diabetes receiving daily insulin since the time of diagnosis for at least 2 years or type 2 diabetes receiving multiple daily insulin doses for at least 2 years
At least 18.0 years of age and less than 65.0 years
Body mass index (BMI) greater than or equal to 20.0 and below or equal to 35.0 kilograms per meter squared (kg/m²)
Weighs at least 50 kg (110 pounds)
Females must meet one of the following criteria:
- Of childbearing potential but agree to use an accepted contraceptive regimen as described in the study procedure manual throughout the entire duration of the study (from the screening until study completion)
- Of non-childbearing potential, defined as a female who has had a hysterectomy or tubal ligation, is clinically considered infertile or is in a menopausal state (at least 1 year without menses)
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
Willingness to adhere to the study requirements

Exclusion criteria

An individual is not eligible if any of the following exclusion criteria are present:

Females who are pregnant according to a positive urine pregnancy test, actively attempting to get pregnant, or are lactating
History of hypersensitivity to glucagon or any related products or severe hypersensitivity reactions (such as angioedema) to any drugs
Presence of cardiovascular, 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
History of pheochromocytoma (i.e. adrenal gland tumor) or insulinoma.
History of an episode of severe hypoglycemia (as defined by an episode that required third party assistance for treatment) in the 1 month prior to enrolling in the study
Use of daily systemic beta-blocker, indomethacin, warfarin or anticholinergic drugs
History of epilepsy or seizure disorder
Regularly consumes 3 or more alcoholic beverages per day
Use of an Investigational Product in another clinical trial within the past 30 days
Donated 225 milliliters (mL) or more of blood in the previous 8 weeks before the first glucagon dosing