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

NCT02146651 | Completed Phase 2

• 1 other identifier: BC3-CT008
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (4)

• Glucodynamic endpoint: Area Under the Curve GIR(0-last)

  Area under the Glucose Infusion Rate time curve from 0 hours until the end of the clamp

  12 hours

• Glucodynamic endpoint: GIRMax

  Maximum Glucose Infusion Rate

  12 hours

• Pharmacokinetic endpoint: AUC Lisp(0-last)

  Area under the insulin lispro serum concentration - time curve over the clamp procedure.

  12 hours

• Pharmacokinetic endpoint: Cmax(Lisp)

  Maximum observed serum insulin lispro concentration

  12 hours

Secondary Outcomes (4)

• Pharmacokinetics: Tmax(lisp)

  12 hours

• Glucodynamic: TGIRmax

  12 hours

• Tonset of action

  12 hours

• Safety and Tolerability: adverse events, local tolerability, vital signs variations, ECG, laboratory safety parameters.

  12 weeks

Study Arms (4)

BioChaperone insulin lispro 0.2U/Kg

EXPERIMENTAL

BioChaperone insulin lispro 0.2U/Kg

Drug: BioChaperone insulin lispro 0.2U/Kg; Drug: BioChaperone insulin lispro 0.1U/Kg; Drug: BioChaperone insulin lispro 0.4U/Kg; Drug: Humalog®

BioChaperone insulin lispro 0.1U/Kg

EXPERIMENTAL

BioChaperone insulin lispro 0.1U/Kg

Drug: BioChaperone insulin lispro 0.2U/Kg; Drug: BioChaperone insulin lispro 0.1U/Kg; Drug: BioChaperone insulin lispro 0.4U/Kg; Drug: Humalog®

BioChaperone insulin lispro 0.4U/Kg

EXPERIMENTAL

BioChaperone insulin lispro 0.4U/Kg

Drug: BioChaperone insulin lispro 0.2U/Kg; Drug: BioChaperone insulin lispro 0.1U/Kg; Drug: BioChaperone insulin lispro 0.4U/Kg; Drug: Humalog®

Humalog® 0.2U/Kg

ACTIVE COMPARATOR

Humalog® 0.2U/Kg

Drug: BioChaperone insulin lispro 0.2U/Kg; Drug: BioChaperone insulin lispro 0.1U/Kg; Drug: BioChaperone insulin lispro 0.4U/Kg; Drug: Humalog®

Interventions

BioChaperone insulin lispro 0.2U/Kg DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg; BioChaperone insulin lispro 0.2U/Kg; BioChaperone insulin lispro 0.4U/Kg; Humalog® 0.2U/Kg

BioChaperone insulin lispro 0.1U/Kg DRUG

Single dose of 0.1U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg; BioChaperone insulin lispro 0.2U/Kg; BioChaperone insulin lispro 0.4U/Kg; Humalog® 0.2U/Kg

BioChaperone insulin lispro 0.4U/Kg DRUG

Single dose of 0.4U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg; BioChaperone insulin lispro 0.2U/Kg; BioChaperone insulin lispro 0.4U/Kg; Humalog® 0.2U/Kg

Humalog® DRUG

Single dose of 0.2U/Kg body weight injected subcutaneously

BioChaperone insulin lispro 0.1U/Kg; BioChaperone insulin lispro 0.2U/Kg; BioChaperone insulin lispro 0.4U/Kg; Humalog® 0.2U/Kg

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil Institut für stoffwechselforschung GmbH

Neuss, 41460, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Grit Andersen, MD

  Profil Institut für Stoffwechselfforschung GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2014
• First Posted: May 26, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 10, 2014

Record last verified: 2014-05

Locations

DE (1)