Conditions: Hypoglycemia
Keywords: Hypoglycemia Glucagon
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 30
Healthy volunteers: yes

Brief summary:
The purpose of this study is to demonstrate that G-Pen(TM) glucagon is comparable to Lilly Glucagon(TM) in terms of safety and efficacy, as a treatment for severe hypoglycemia, a complication of diabetes.

Detailed description:
Primary objective: To Evaluate the Safety and Tolerability of G-Pen™ (Glucagon Injection) 1 mg

Secondary objective (1): To Evaluate the pharmacodynamics (Efficacy) of G-Pen™ (Glucagon Injection) 1 mg

Secondary objective (2):To compare the pharmacokinetics of G-Pen™ (glucagon injection) 1mg \[test\] administered as 0.5 mg and 1 mg injections, versus Lilly Glucagon™ (glucagon for injection \[rDNA origin\]) 1 mg (reference)

Arms:
arm 1: G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection arm 2: G-Pen(TM) (glucagon injection), single 0.5 mg SC injection arm 3: Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection

Interventions: intervention 1: G-Pen(TM) 1 mg intervention 2: Lilly Glucagon(TM) 1 mg intervention 3: G-Pen(TM) 0.5 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol document: