G-Pen™ for Hypoglycemia Rescue in T1D
| Status: | Completed |
|---|---|
| Conditions: | Endocrine |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/21/2016 |
| Start Date: | April 2015 |
| End Date: | June 2015 |
G-Pen™ (Glucagon Injection) for Induced Hypoglycemia Rescue in Adult Patients With T1D
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.
two daytime clinical research center visits 7-14 days apart. Subjects will receive a single
injection of G-Pen™ (glucagon injection) at each visit.
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
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