AT278 and NovoRapid® in Glucose Clamp Study

Arecor Limited38 enrolled

Overview

A phase 1, randomised, single-centre, double-blind, single-dose, two period balanced cross over study in a glucose clamp setting. The study compares the pharmacodynamic, pharmacokinetic and safety characteristics of AT278 and NovoRapid® in male participants with type 1 diabetes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

AT278DRUG

Concentrated rapid acting insulin aspart

NovoRapidDRUG

Rapid acting insulin aspart

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of type 1 diabetes for at least 12 months 2. Receiving treatment with multiple daily insulin injections or insulin pump therapy for at least 12 months 3. HbA1c concentration ≤8.5% at screening 4. Weight within the range 75kg - 100kg (both inclusive) Exclusion Criteria: 1. Known or suspected hypersensitivity to Investigational Medicinal Products 2. Clinically significant concomitant disease or abnormal lab values 3. Supine systolic BP outside range 95-140mmHg and/or diastolic BP greater than 90mmHG

Locations (1)

Clinical Trials Unit, Medical University of Graz

Graz, Austria

Outcomes

Primary Outcomes

Area under the glucose infusion-rate curve of insulin aspart

Time frame: 0 - 8 hours

Data from ClinicalTrials.gov

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