G-Pen™ for Hypoglycemia Rescue in T1D Patients

Completed · Phase 2

Conditions studied: Hypoglycemia

In brief

This is an open-label, exploratory pilot study in patients with T1D. The study will involve two daytime clinical research center visits 7-14 days apart. Subjects will receive a single injection of G-Pen™ (glucagon injection) at each visit.

Key facts

Study ID

NCT02423980

Run by

Xeris Pharmaceuticals

People needed

7

Starts

2015-04-01

Expected to finish

2015-06-01

Last updated by the study team

2017-07-07

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Type 1 diabetes mellitus for at least 24 months

You may not qualify if…

• Pregnant or Lactating
• HbA1c >10.5% at screening
• Use of > 2.0 U/kg total insulin dose per day
• Inadequate bilateral venous access in both arms
• Renal insufficiency
• Congestive heart failure, NYHA class II, III or IV
• Active malignancy within 5 years from screening
• Major surgical operation within 30 days prior to screening
• Seizure or bleeding disorder
• Glycogen storage disease
• Active substance or alchohol abuse

Where it is running

• Diablo Clinical Research, Inc. — Walnut Creek, California, United States

Full record on ClinicalTrials.gov

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