AT278, NovoRapid® and Humulin® R (U500) in Glucose Clamp Study

Arecor Limited41 enrolled

Overview

This is a phase 1, single dose, randomised, double-blind, two-way crossover study to compare ultra-rapid-acting concentrated insulin aspart AT278 (U500/mL) with standard insulin aspart NovoRapid® (U100/mL) in participants with T2D. Participants and Investigators will be blinded to both study interventions. Humulin® R U-500 (U500/mL), a highly concentrated regular human insulin, will be used as an open-label comparator.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus, Type 2

Interventions

AT278DRUG

Concentrated rapid acting insulin aspart

NovoRapidDRUG

Rapid-acting insulin aspart

Humulin R 500 UNT/ML Injectable SolutionDRUG

Regular human insulin

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of type 2 diabetes for at least 180 days prior to the day of screening * Haemoglobin A1C (HbA1c) concentration of ≤9.5% (≤80 mmol/mol) at screening. * BMI within the range of 25 - 45 kg/m2 (both inclusive) Exclusion Criteria: * Known or suspected hypersensitivity to IMPs or related products * Clinically significant concomitant disease or abnormal lab values * Severe asthma or chronic obstructive pulmonary disease (GOLD III and IV), or lower if requiring high dose of corticosteroids or beta2-adrenergic agonists

Locations (1)

Clinical Trials Unit, Medical University of Graz

Graz, Austria

Outcomes

Primary Outcomes

Area under the glucose infusion rate-time curve of insulin aspart

Time frame: 0 to 60 minutes

Data from ClinicalTrials.gov

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