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

Abvance Therapeutics1 site in 1 country15 target enrollmentSeptember 15, 2020

ConditionsType 1 Diabetes Mellitus With Hypoglycemia

InterventionsInsulin Glucagon

DrugsGlucagon Insulin

Overview

Phase: Early Phase 1
Intervention: Insulin
Conditions: Type 1 Diabetes Mellitus With Hypoglycemia
Sponsor: Abvance Therapeutics
Enrollment: 15
Locations: 1
Primary Endpoint: hyperglycemic excursions
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

September 15, 2020

End Date

January 10, 2021

Last Updated

5 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Abvance Therapeutics

Responsible Party

Sponsor

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