A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Study Details
Study Description
Brief Summary
This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
Early Phase 1 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Active Comparator: Insulin IV calculated insulin rate |
Drug: Insulin
calculated IV Insulin dose infused at a constant rate
Other Names:
|
Experimental: Insulin and Glucagon IV calculated molar ratio insulin:glucagon |
Drug: Glucagon
calculated IV insulin:Glucagon molar ratio
Other Names:
Drug: Insulin
calculated IV Insulin dose infused at a constant rate
Other Names:
|
Outcome Measures
Primary Outcome Measures
- hypoglycemic excursions [180-360 minutes post meal]
< 50mg/dl
- hyperglycemic excursions [60-120 minutes post meal]
>150mg/dl
Eligibility Criteria
Criteria
Inclusion Criteria:
-
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 Criteria:
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Atlanta Diabetes Associates | Atlanta | Georgia | United States | 30318 |
Sponsors and Collaborators
- Abvance Therapeutics
- T1D Exchange, United States
Investigators
- Principal Investigator: Bruce Bode, MD, Atlanta Diabetes Associates
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ABV201