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

Early Phase 1

Completed

• Conditions: Type 1 Diabetes Mellitus With Hypoglycemia
• Interventions: Drug: Insulin; Drug: Glucagon

• Registration Number: NCT04712266
• Lead Sponsor: Abvance Therapeutics

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.

Study Timeline

• Study Start: 2020-09-15
• Primary Completion: 2020-12-15
• Status Verified: 2021-01
• Study Completion: 2021-01-10
• Study First Submitted: 2021-01-12
• Study First Submitted QC: 2021-01-14
• Last Update Submitted: 2021-01-14
• Study First Posted: 2021-01-15
• Last Update Posted: 2021-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Insulin IV	Insulin	calculated insulin rate
Insulin and Glucagon IV	Insulin	calculated molar ratio insulin:glucagon
Insulin and Glucagon IV	Glucagon	calculated molar ratio insulin:glucagon

Primary Outcome Measures

Name	Time	Method
hyperglycemic excursions	60-120 minutes post meal	\>150mg/dl
hypoglycemic excursions	180-360 minutes post meal	\< 50mg/dl

Trial Locations

Locations (1)

Atlanta Diabetes Associates; 🇺🇸 Atlanta, Georgia, United States