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

• Status: Completed
• Trial end date: 2015-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zosano Pharma Corporation; Zosano Pharma Inc.
• Treatments: Glucagon; Glucagon-Like Peptide 1

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