A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Phase 1CompletedNCT02029924

Adocia37 enrolled

Overview

The addition of Biochaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to a facilitation of the absorption of the insulin after subcutaneous injection. The aim of the trial is to assess the efficacy and safety of BioChaperone insulin lispro in subjects with Type 1 diabetes under a dose of 0.2 U/Kg. This trial is a single-center, randomised, double-blinded, two-treatment, two-period cross-over, 6-hour euglycaemic glucose clamp trial in subjects with Type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone insulin lispro 0.2 U/Kg and a single dose of Humalog® 0.2 U/Kg on 2 separate dosing visits.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Diabetes Mellitus Type 1

Interventions

Eligibility

Sex: MALEMin age: 18 YearsMax age: 64 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Type 1 diabetes mellitus for at least 12 months. * Treated with multiple daily insulin injections or insulin pump for at least 12 months. * Body Mass Index (BMI): 18.0-28.0 Kg/m². Exclusion Criteria: * Type 2 diabetes mellitus. * Receipt of any investigational product within 3 months prior to first dosing. * Clinically significant abnormalities as judged by the investigator. * Any systemic treatment with drugs known to interfere with glucose metabolism. * History of alcoholism, or drug/chemical abuse as per Investigator's judgement. * Use of tobacco or nicotine-contained product within 5 years prior to screening. * Blood or plasma donation in the past month or more than 500 mL within 3 months prior to screening.

Outcomes

Primary Outcomes

Area under the curve (AUC)

Area under the curve of the insulin lispro concentration - time curve from 0 to 30 minutes

Time frame: 30 minutes

Secondary Outcomes

Pharmacokinetics: Early t0.5max(Lisp)

Time to first observed half maximum observed insulin lispro concentration

Time frame: up to 6 hours post administration of study drug

Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 6 hours

Time frame: 6 hours

Glucodynamics: Early t0.5(GIRmax)

Time to first observed half maximum glucose infusion rate

Time frame: 6 hours

Glucodynamic: GIRmax (Maximum glucose infusion rate)

Time frame: 6 hours

Pharmacokinetics: Area under the insulin lispro serum concentration. Time curve from t=0 to 6 hours

Time frame: 6 hours

Pharmacokinetics: tmax(Lisp) - Time from t=0 hours to maximum observed insulin lispro concentration

Time frame: 6 hours

Safety and Tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

Time frame: 8 weeks

A Double-blinded, Randomised, Two -Period Crossover Euglycemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Insulin Lispro and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes