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

NCT02029924 | Completed Phase 1

• 1 other identifier: BC3-CT006
• Study Type: interventional
• Target: 37
• 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 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.

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUC)

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

  30 minutes

Secondary Outcomes (7)

• Pharmacokinetics: Early t0.5max(Lisp)

  up to 6 hours post administration of study drug

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

  6 hours

• Glucodynamics: Early t0.5(GIRmax)

  6 hours

• Glucodynamic: GIRmax (Maximum glucose infusion rate)

  6 hours

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

  6 hours

Study Arms (2)

BioChaperone insulin lispro

EXPERIMENTAL

BioChaperone insulin lispro

Drug: BioChaperone insulin lispro

Humalog®

ACTIVE COMPARATOR

Humalog®

Drug: Humalog®

Interventions

BioChaperone insulin lispro DRUG

Single dose of 0.2 U/Kg body weight injected subcutaneously (under the skin)

BioChaperone insulin lispro

Humalog® DRUG

Single dose of 0.2 /Kg body weight injected subcutaneously (under the skin)

Humalog®

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 or insulin pump for at least 12 months.
• Body Mass Index (BMI): 18.0-28.0 Kg/m².

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Unknown Facility

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 Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2013
• First Posted: January 8, 2014
• Study Start: December 1, 2013
• Primary Completion: March 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 1, 2017

Record last verified: 2014-09

Locations

DE (1)