A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

NCT02213146 | Completed Phase 1

• 1 other identifier: BC3-CT010
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection. The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg. This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.

Conditions

Diabetes Mellitus Type 1

Outcome Measures

Primary Outcomes (1)

• Area under the curve (AUCins(0-1h))

  Area under the human insulin serum concentration - time curve from t=0 to 1 hour

  1 hour

Secondary Outcomes (9)

• Pharmacokinetics: Early t0.5max ins/lisp

  up to 10 hours post administration

• Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours

  10 hours

• Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax)

  10 hours

• Glucodynamics: GIRmax - Maximum glucose infusion rate

  10 hours

• Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration

  10 hours

Study Arms (3)

BioChaperone human insulin

EXPERIMENTAL

BioChaperone Human Insulin

Drug: BioChaperone human insulin; Drug: Huminsulin® Normal; Drug: Humalog®

Human insulin

ACTIVE COMPARATOR

Huminsulin® Normal

Drug: BioChaperone human insulin; Drug: Huminsulin® Normal; Drug: Humalog®

Insulin lispro

ACTIVE COMPARATOR

Humalog®

Drug: BioChaperone human insulin; Drug: Huminsulin® Normal; Drug: Humalog®

Interventions

BioChaperone human insulin DRUG

Single dose of 0.2 U/kg body weight injected subcutaneously

BioChaperone human insulin; Human insulin; Insulin lispro

Huminsulin® Normal DRUG

Single dose of 0.2 U/kg body weight injected subcutaneously

BioChaperone human insulin; Human insulin; Insulin lispro

Humalog® DRUG

Single dose of 0.2 U/kg body weight injected subcutaneously

BioChaperone human insulin; Human insulin; Insulin lispro

Eligibility Criteria

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

You may qualify if:

• Male subject with type 1 diabetes for at least 12 months
• Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
• Body mass index: 18.5-28.0 kg BW·m-2
• HbA1c: ≤ 9.0%

You may not qualify if:

• Diabetes mellitus type 2
• Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
• 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 any tobacco or nicotine-contained product within one year prior to screening

Sponsors & Collaborators

• Adocia: lead

Study Sites (1)

Profil 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 GmbH

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• 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: August 8, 2014
• First Posted: August 11, 2014
• Study Start: August 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: June 1, 2015
• Last Updated: June 1, 2017

Record last verified: 2015-06

Locations

DE (1)