A Trial to Investigate Hyperglycemic and Hypoglycemic Excursions in Subjects With Type 1 Diabetes

Sponsor
Abvance Therapeutics (Industry)
Overall Status
Completed
CT.gov ID
NCT04712266
Collaborator
T1D Exchange, United States (Other)
15
1
2
3.8
3.9

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

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Sep 15, 2020
Actual Primary Completion Date :
Dec 15, 2020
Actual Study Completion Date :
Jan 10, 2021

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:
  • Human Insulin (Eli Lilly)
  • Experimental: Insulin and Glucagon IV

    calculated molar ratio insulin:glucagon

    Drug: Glucagon
    calculated IV insulin:Glucagon molar ratio
    Other Names:
  • Glucagen Hypokit
  • Drug: Insulin
    calculated IV Insulin dose infused at a constant rate
    Other Names:
  • Human Insulin (Eli Lilly)
  • Outcome Measures

    Primary Outcome Measures

    1. hypoglycemic excursions [180-360 minutes post meal]

      < 50mg/dl

    2. hyperglycemic excursions [60-120 minutes post meal]

      >150mg/dl

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 64 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.
    Responsible Party:
    Abvance Therapeutics
    ClinicalTrials.gov Identifier:
    NCT04712266
    Other Study ID Numbers:
    • ABV201
    First Posted:
    Jan 15, 2021
    Last Update Posted:
    Jan 15, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jan 15, 2021