A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
NCT04712266 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15
Last updated 2021-01-15
Summary
This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
Conditions
- Type 1 Diabetes Mellitus With Hypoglycemia
Interventions
- DRUG
-
Glucagon
calculated IV insulin:Glucagon molar ratio
- DRUG
-
calculated IV Insulin dose infused at a constant rate
Sponsors & Collaborators
-
T1D Exchange, United States
collaborator OTHER -
Abvance Therapeutics
lead INDUSTRY
Principal Investigators
-
Bruce Bode, MD · Atlanta Diabetes Associates
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-09-15
- Primary Completion
- 2020-12-15
- Completion
- 2021-01-10
- FDA Drug
- Yes
Countries
- United States
Study Locations
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