Clinical Trials Directory

Trials / Completed

CompletedNCT02081014

Safety and Efficacy Study of Mini-Dose Glucagon (G-Pen Mini) in Patients With Type 1 Diabetes

A Randomized, Phase 2a, Blinded, 3-Way Crossover Dose-Ranging Study With G-Pen Mini™ (Glucagon Injection) to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Patients With Type 1 Diabetes Mellitus (T1DM)

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
13 (actual)
Sponsor
Xeris Pharmaceuticals · Industry
Sex
All
Age
18 Years – 50 Years
Healthy volunteers
Not accepted

Summary

The purpose of the study is to demonstrate that mini-doses of stable liquid glucagon (G-Pen Mini) produced by Xeris Pharmaceuticals are safe and effective as a treatment for mild to moderate hypoglycemia, a complication of diabetes.

Conditions

Interventions

TypeNameDescription
DRUGG-Pen Mini™ (glucagon injection)stable, pre-mixed, liquid glucagon for subcutaneous injection

Timeline

Start date
2014-03-01
Primary completion
2014-11-01
Completion
2014-11-01
First posted
2014-03-07
Last updated
2018-04-05
Results posted
2016-05-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02081014. Inclusion in this directory is not an endorsement.