Safety and Efficacy of ZP-Glucagon to Injectable Glucagon for Hypoglycemia

Condition(s) targeted: Hypoglycemia

Intervention: Glucagon (ZP-Glucagon) (Drug); Glucagon (GlucaGen) (Drug)

Phase: Phase 1/Phase 2

Status: Active, not recruiting

Sponsored by: Zosano Pharma Inc.

Official(s) and/or principal investigator(s):
Neale Cohen, MD, Principal Investigator, Affiliation: Baker ID Heart and Diabetes Institute

The purpose of this study is to determine whether glucagon administered by microneedle patch is comparable to glucagon administered by injection pen in the treatment of insulin-induced hypoglycemia.

Official title: A Randomized Open-label Crossover Study to Compare the Safety and Efficacy of ZP-Glucagon to Injectable Glucagon in the Treatment of Insulin-induced Hypoglycemia in Subjects With Type-1 Diabetes

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Percentage of subjects achieving normoglycemia

Secondary outcome:

Time at which normoglycemia is first reached

Time at which maximal glucose levels are reached

Increases in blood glucose by 15 minute intervals

Peak Plasma Concentration (Cmax)

Area under the plasma concentration versus time curve (AUC)

Detailed description: The purpose of this study is to compare ZP-Glucagon transdermal patch system at doses of 0. 5 mg and 1 mg to glucagon by injection at doses of 0. 5 mg and 1 mg by means of a 4 way crossover open label design. Eligible subjects giving informed consent will be randomised to a treatment sequence of each of the four treatments in one week intervals. At each treatment visit, subjects will undergo an insulin induction procedure designed to safely induce hypoglycemia, and then have a treatment applied, either by injection or by patch, and then monitored for return to normoglycemia.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Women or men 18 to 60 years with type-1 diabetes on daily insulin treatment

(basal-bolus injection regimen or insulin pump) for at least two years, on a total daily dose that has been stable for the last 3 months preceding enrollment (no more than 20% variation), and with a current level of glycated hemoglobin between 6. 5% and 10% Exclusion Criteria:

- Any history of hypoglycemic coma or hypoglycemic seizures.

- Any episode of severe hypoglycemia (requiring treatment) within one month prior to

study start.

- Any history of pheochromocytoma or insulinoma

Nucleus Network, Melbourne, Victoria 3005, Australia

Starting date: January 2015
Last updated: July 14, 2015