Conditions: Hypoglycemia
Keywords: Hypoglycemia Diabetes mellitus
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 18
Healthy volunteers: no

Brief summary:
In this study, participants with Type 1 diabetes received insulin through an infusion into a vein to reduce their blood glucose, and then received nasal glucagon (NG) or glucagon for injection under the skin, and their blood glucose was measured for 3 hours.

The main objective of this study was to evaluate the safety and efficacy of intranasal and subcutaneous glucagon (SC) in reversing insulin-induced hypoglycemia in participants with type 1 diabetes.

Detailed description:
In the study, up to four (4) treatments were administered as a single dose either intranasally or subcutaneously to eighteen (18) male or female participants under fasting conditions and following the use of insulin to lower blood glucose. The participants were assigned at random to a group that received one treatment for each of the 3 study periods. The glucagon administrations were separated by approximately 7 calendar days. For 2 participants, a single dose of 3 mg NG was administered at the 4th period that was separated by at least 21 calendar days from the 3rd period.

Arms:
arm 1: Nasal glucagon (NG) administered as single dose of 1 milligram (mg). arm 2: NG administered as single dose of 2 mg. arm 3: Glucagon solution dose of 1 mg administered as a single subcutaneous (SC) injection. arm 4: NG administered as single dose of 3 mg (composed of one dose of 1 mg NG immediately followed by one dose of 2mg NG).

Interventions: intervention 1: Nasal Glucagon 1 mg intervention 2: Nasal Glucagon 2 mg intervention 3: SC Glucagon intervention 4: Nasal Glucagon 3 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: