Skip to main content
OpenTrials
Completed

NCT Number: NCT04712266

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

-

Treatment and study plan

glucagon

Drug

calculated IV insulin:Glucagon molar ratio

Other names: Glucagen Hypokit

Insulin

Drug

calculated IV Insulin dose infused at a constant rate

Other names: Human Insulin (Eli Lilly)

Primary outcomes

  1. hypoglycemic excursions

    Time frame: 180-360 minutes post meal

    < 50mg/dl

  2. hyperglycemic excursions

    Time frame: 60-120 minutes post meal

    >150mg/dl

Sponsors and collaborators

Lead sponsor

Abvance Therapeutics

Industry

Collaborators

  • T1D Exchange, United States

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Jan 15, 2021
Registry last updated
Jan 15, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.