G-Pen™ for Hypoglycemia Rescue in T1D

Hypoglycemia Clinical Trial

Official title:

G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02423980
• Other study ID #: XSGP-202
• Status: Completed
• Phase: Phase 2
• First received: April 9, 2015
• Last updated: October 25, 2015
• Start date: April 2015
• Est. completion date: June 2015

Study information

• Verified date: October 2015
• Source: Xeris Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: June 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Type 1 diabetes mellitus for at least 24 months

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypoglycemia

Intervention

Drug:
• Glucagon

Locations

Country	Name	City	State
United States	Diablo Clinical Research, Inc.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Xeris Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with plasma glucose > 70 mg/dl at 30 minutes post-treatment	For 90 minutes following treatment, plasma glucose with be measured every 5 minutes with an increase in plasma glucose to >70 mg/dl within 30 minutes of treatment being considered a positive response.	0-90 minutes	No
Secondary	Time to plasma glucose > 70 mg/dl	Following treatment, time in minutes required for plasma glucose to reach a concentration >70 mg/dl will be determined for each subject.	0-90 minutes	No
Secondary	Changes in hypoglycemia symptom scores from baseline to 30 minutes post-treatment will be assessed with a hypoglycemia symptom questionnaire.		0-30 minutes	No