Status:
COMPLETED
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Lead Sponsor:
Abvance Therapeutics
Collaborating Sponsors:
T1D Exchange, United States
Conditions:
Type 1 Diabetes Mellitus With Hypoglycemia
Eligibility:
All Genders
18-64 years
Phase:
EARLY_PHASE1
Brief 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-adminis...
Eligibility Criteria
Inclusion
- Male or female patients aged between 18 and 64 years (both inclusive)
- Type 1 diabetes mellitus (as diagnosed clinically) ≥ 12 months prior to the screening visit
- Treated with daily insulin for T1DM ≥ 12 months prior to the screening visit
Exclusion
- \-
Key Trial Info
Start Date :
September 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 10 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT04712266
Start Date
September 15 2020
End Date
January 10 2021
Last Update
January 15 2021
Active Locations (1)
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1
Atlanta Diabetes Associates
Atlanta, Georgia, United States, 30318