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CompletedNCT02146651Updated Dec 10, 2014

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

A Phase 2 interventional study of BioChaperone insulin lispro 0.2U/Kg and BioChaperone insulin lispro 0.1U/Kg in Diabetes Mellitus Type 1, sponsored by Adocia. Completed at 1 site in Germany. Open to male participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2014-12-10.

Sponsored by Adocia · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
38
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Male
01

Study 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.

02

Conditions studied

  • Diabetes Mellitus Type 1
03

In context

Diabetes Mellitus, Type 1

3,614 studies on the registry are indexed under Diabetes Mellitus, Type 1; 586 are open to participants now.

This study's enrollment of 38 is close to the median of 40 across 2,718 interventional studies indexed under Diabetes Mellitus, Type 1.

Browse Diabetes Mellitus, Type 1 studies →

Lead sponsor

Adocia is the lead sponsor of 27 studies on the registry; none are open to participants now.

Browse Adocia studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 64 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
38 participants (actual)

Study arms

  • Experimental
    BioChaperone insulin lispro 0.2U/Kg

    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®

  • Experimental
    BioChaperone insulin lispro 0.1U/Kg

    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®

  • Experimental
    BioChaperone insulin lispro 0.4U/Kg

    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®

  • Active comparator
    Humalog® 0.2U/Kg

    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

  • DrugBioChaperone insulin lispro 0.2U/Kg

    Single dose of 0.2U/Kg body weight injected subcutaneously

  • DrugBioChaperone insulin lispro 0.1U/Kg

    Single dose of 0.1U/Kg body weight injected subcutaneously

  • DrugBioChaperone insulin lispro 0.4U/Kg

    Single dose of 0.4U/Kg body weight injected subcutaneously

  • DrugHumalog®

    Single dose of 0.2U/Kg body weight injected subcutaneously

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 hours

  2. Glucodynamic endpoint: GIRMax

    Maximum Glucose Infusion Rate

    Time frame: 12 hours

  3. Pharmacokinetic endpoint: AUC Lisp(0-last)

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

    Time frame: 12 hours

  4. Pharmacokinetic endpoint: Cmax(Lisp)

    Maximum observed serum insulin lispro concentration

    Time frame: 12 hours

Secondary outcomes

  1. Pharmacokinetics: Tmax(lisp)

    Time to maximum observed serum insulin lispro concentration

    Time frame: 12 hours

  2. Glucodynamic: TGIRmax

    Time to maximum Glucose Infusion Rate

    Time frame: 12 hours

  3. Tonset of action

    Time from t=0 until blood glucose concentration has decreased by 5mg.dL (0.3mmol.L) from baseline.

    Time frame: 12 hours

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

    Time frame: 12 weeks

07

Study locations

1 site
  • Profil Institut für stoffwechselforschung GmbH
    Neuss, 41460, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02146651
Lead sponsor
Adocia
Responsible party
Sponsor
First posted
May 26, 2014
Start date
May 2014
Primary completion
Jul 2014
Completion
Dec 2014
Last update
Dec 10, 2014

Study contacts

Grit Andersen, MD
principal investigator · Profil Institut für Stoffwechselfforschung GmbH

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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