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

January 14, 2021 updated by: Abvance Therapeutics

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

This is a single center, double-blind, randomized trial in subjects with type 1 diabetes mellitus applying an adaptive design approach.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associates

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoglycemic excursions
Time Frame: 180-360 minutes post meal
< 50mg/dl
180-360 minutes post meal
hyperglycemic excursions
Time Frame: 60-120 minutes post meal
>150mg/dl
60-120 minutes post meal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abvance Therapeutics

Collaborators

T1D Exchange, United States

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

December 15, 2020

Study Completion (Actual)

January 10, 2021

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 14, 2021

First Posted (Actual)

January 15, 2021

Study Record Updates

Last Update Posted (Actual)

January 15, 2021

Last Update Submitted That Met QC Criteria

January 14, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABV201

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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