A Double-blinded, Randomised, Four-period Crossover Euglycemic Clamp Trial Investigating the Dose-response and Dose-exposure Relationship of BioChaperone Insulin Lispro in Three Different Doses in Subjects With Type 1 Diabetes
Overview
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Adocia
- Enrollment
- 38
- Locations
- 1
- Primary Endpoint
- Glucodynamic endpoint: Area Under the Curve GIR(0-last)
Overview
Brief Summary
The addition of BioChaperone to insulin lispro may accelerate the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.
The aim of the trial is to investigate the dose-response and the dose-exposure relationships of BioChaperone insulin lispro under 3 doses, to compare the pharmacokinetics and glucodynamic action of BioChaperone insulin lispro at 0.2U/Kg with Humalog® at 0.2 U/Kg and to assess safety and tolerability of BioChaperone insulin lispro and Humalog®.
This is a double-blinded, randomised, four-period crossover phase 2 trial using automated 12-hour euglycemic clamps in subject with type 1 diabetes mellitus.
Each subject will be randomly allocated to a sequence of 4 treatments, i.e. with one of three single doses of BioChaperone insulin lispro (0.1, 0.2 and 0.4 U/Kg) or one single dose of Humalog® (0.2 U/Kg) on 4 separate dosing visits.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 64 Years (Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Type 1 diabetes mellitus for at least 12 months
- •Treated with multiple daily insulin injections of insulin pump for at least 12 months
- •Body Mass Index (BMI): 18.5-28.0 Kg.m²
Exclusion Criteria
- •Type 2 diabetes mellitus
- •Receipt of any investigational product within 3 months prior 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 1 year prior to screening
- •Blood or plasma donation in the past month or more than 500ml within 3 months prior to screening
Arms & Interventions
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
Intervention: BioChaperone insulin lispro 0.2U/Kg (Drug)
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
Intervention: BioChaperone insulin lispro 0.1U/Kg (Drug)
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
Intervention: BioChaperone insulin lispro 0.4U/Kg (Drug)
BioChaperone insulin lispro 0.2U/Kg
BioChaperone insulin lispro 0.2U/Kg
Intervention: Humalog® (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
Intervention: BioChaperone insulin lispro 0.2U/Kg (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
Intervention: BioChaperone insulin lispro 0.1U/Kg (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
Intervention: BioChaperone insulin lispro 0.4U/Kg (Drug)
BioChaperone insulin lispro 0.1U/Kg
BioChaperone insulin lispro 0.1U/Kg
Intervention: Humalog® (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
Intervention: BioChaperone insulin lispro 0.2U/Kg (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
Intervention: BioChaperone insulin lispro 0.1U/Kg (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
Intervention: BioChaperone insulin lispro 0.4U/Kg (Drug)
BioChaperone insulin lispro 0.4U/Kg
BioChaperone insulin lispro 0.4U/Kg
Intervention: Humalog® (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
Intervention: BioChaperone insulin lispro 0.2U/Kg (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
Intervention: BioChaperone insulin lispro 0.1U/Kg (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
Intervention: BioChaperone insulin lispro 0.4U/Kg (Drug)
Humalog® 0.2U/Kg
Humalog® 0.2U/Kg
Intervention: Humalog® (Drug)
Outcomes
Primary Outcomes
Glucodynamic endpoint: Area Under the Curve GIR(0-last)
Time Frame: 12 hours
Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp
Glucodynamic endpoint: GIRMax
Time Frame: 12 hours
Maximum Glucose Infusion Rate
Pharmacokinetic endpoint: AUC Lisp(0-last)
Time Frame: 12 hours
Area under the insulin lispro serum concentration - time curve over the clamp procedure.
Pharmacokinetic endpoint: Cmax(Lisp)
Time Frame: 12 hours
Maximum observed serum insulin lispro concentration
Secondary Outcomes
- Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.(12 weeks)
- Pharmacokinetics: Tmax(lisp)(12 hours)
- Glucodynamic: TGIRmax(12 hours)
- Tonset of action(12 hours)