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

Early Phase 1CompletedNCT04712266

Abvance Therapeutics15 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

Interventions

GlucagonDRUG

calculated IV insulin:Glucagon molar ratio

InsulinDRUG

calculated IV Insulin dose infused at a constant rate

Eligibility

Sex: ALLMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

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: \-

Locations (1)

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

hypoglycemic excursions

\< 50mg/dl

Time frame: 180-360 minutes post meal

hyperglycemic excursions

\>150mg/dl

Time frame: 60-120 minutes post meal

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.