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

Launched by ZOSANO PHARMA CORPORATION · May 28, 2015

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility 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