Back to resultsA Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes Mellitus With Hypoglycemia
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Glucagon
Insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type 1 Diabetes Mellitus With Hypoglycemia
Eligibility 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:
-
Sites / Locations
- Atlanta Diabetes Associates
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Insulin IV
Insulin and Glucagon IV
Arm Description
calculated insulin rate
calculated molar ratio insulin:glucagon
Outcomes
Primary Outcome Measures
hypoglycemic excursions
< 50mg/dl
hyperglycemic excursions
>150mg/dl
Secondary Outcome Measures
Full Information
NCT ID
NCT04712266
First Posted
January 12, 2021
Last Updated
January 14, 2021
Sponsor
Abvance Therapeutics
Collaborators
T1D Exchange, United States
1. Study Identification
Unique Protocol Identification Number
NCT04712266
Brief Title
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
September 15, 2020 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
January 10, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abvance Therapeutics
Collaborators
T1D Exchange, United States
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus With Hypoglycemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Insulin IV
Arm Type
Active Comparator
Arm Description
calculated insulin rate
Arm Title
Insulin and Glucagon IV
Arm Type
Experimental
Arm Description
calculated molar ratio insulin:glucagon
Intervention Type
Drug
Intervention Name(s)
Glucagon
Other Intervention Name(s)
Glucagen Hypokit
Intervention Description
calculated IV insulin:Glucagon molar ratio
Intervention Type
Drug
Intervention Name(s)
Insulin
Other Intervention Name(s)
Human Insulin (Eli Lilly)
Intervention Description
calculated IV Insulin dose infused at a constant rate
Primary Outcome Measure Information:
Title
hypoglycemic excursions
Description
< 50mg/dl
Time Frame
180-360 minutes post meal
Title
hyperglycemic excursions
Description
>150mg/dl
Time Frame
60-120 minutes post meal
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruce Bode, MD
Organizational Affiliation
Atlanta Diabetes Associates
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atlanta Diabetes Associates
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30318
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes
We'll reach out to this number within 24 hrs