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

Abvance Therapeutics

Status and phase: Completed; Early Phase 1

Conditions: Type 1 Diabetes Mellitus With Hypoglycemia

Treatments: Drug: Glucagon; Drug: Insulin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04712266

ABV201

Details and patient eligibility

About

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

Full 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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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15 participants in 2 patient groups

Insulin IV

Active Comparator group

Description:

calculated insulin rate

Treatment:

Drug: Insulin

Insulin and Glucagon IV

Experimental group

Description:

calculated molar ratio insulin:glucagon

Treatment:

Drug: Insulin

Drug: Glucagon