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Completed

NCT Number: NCT02459938

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

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.

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Key information

Conditions

Hypoglycemia Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Nucleus Network

Melbourne, Victoria, 3005, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glucagon (ZP-Glucagon)

Drug

chemically synthesized glucagon as delivered via transdermal microneedle patch system for 30 minutes

Other names: glucagon

Glucagon (GlucaGen)

Drug

recombinant glucagon administered via subcutaneous injection

Other names: glucagon

Primary outcomes

  1. Percentage of subjects achieving normoglycemia

    Time frame: 30 minutes

Secondary outcomes

  1. Time at which normoglycemia is first reached

    Time frame: 3 hours

  2. Time at which maximal glucose levels are reached

    Time frame: 3 hours

  3. Increases in blood glucose by 15 minute intervals

    Time frame: 3 hours

  4. Peak Plasma Concentration (Cmax)

    Time frame: 3 hours

  5. Area under the plasma concentration versus time curve (AUC)

    Time frame: 3 hours

Sponsors and collaborators

Lead sponsor

Zosano Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 2, 2015
Registry last updated
Aug 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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