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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-15

Study Completion Date

2021-01-10

Brief Summary

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

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Detailed Description

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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.

Conditions

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Type 1 Diabetes Mellitus With Hypoglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Insulin IV

calculated insulin rate

Group Type ACTIVE_COMPARATOR

Insulin

Intervention Type DRUG

calculated IV Insulin dose infused at a constant rate

Insulin and Glucagon IV

calculated molar ratio insulin:glucagon

Group Type EXPERIMENTAL

Glucagon

Intervention Type DRUG

calculated IV insulin:Glucagon molar ratio

Insulin

Intervention Type DRUG

calculated IV Insulin dose infused at a constant rate

Interventions

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Glucagon

calculated IV insulin:Glucagon molar ratio

Intervention Type DRUG

Insulin

calculated IV Insulin dose infused at a constant rate

Intervention Type DRUG

Other Intervention Names

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Glucagen Hypokit Human Insulin (Eli Lilly)

Eligibility Criteria

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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