Trials / Completed
CompletedNCT04712266
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
A Randomized, Double-blinded Trial to Investigate Glycemic Excursions Following an Oral Mixed Meal Challenge in Subjects With Type 1 Diabetes When Concomitantly Treated With Insulin Alone or Co-administered Insulin and Glucagon
- Status
- Completed
- Phase
- EARLY_Phase 1
- Study type
- Interventional
- Enrollment
- 15 (actual)
- Sponsor
- Abvance Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
Detailed description
Subjects were be studied on two occasions, in randomized sequence, whereby glycemic excursions are assessed following an oral mixed meal challenge while treated with either insulin alone or co-administered insulin and glucagon.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Glucagon | calculated IV insulin:Glucagon molar ratio |
| DRUG | Insulin | calculated IV Insulin dose infused at a constant rate |
Timeline
- Start date
- 2020-09-15
- Primary completion
- 2020-12-15
- Completion
- 2021-01-10
- First posted
- 2021-01-15
- Last updated
- 2021-01-15
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04712266. Inclusion in this directory is not an endorsement.