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

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

Status

Completed

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04712266

Enrollment

Registered

2021-01-15

Start date

2020-09-15

Completion date

2021-01-10

Last updated

2021-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia

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.

Interventions

DRUGGlucagon

calculated IV insulin:Glucagon molar ratio

DRUGInsulin

calculated IV Insulin dose infused at a constant rate

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 64 Years

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026