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Diabetes Mellitus Type 1Phase 2NCT02146651

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 study testing BioChaperone insulin lispro 0.2U/Kg, BioChaperone insulin lispro 0.1U/Kg and BioChaperone insulin lispro 0.4U/Kg in people with Diabetes Mellitus Type 1, run by Adocia at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 64 years, men only
Conditions the study is for
Diabetes Mellitus Type 1
What is being tested?
BioChaperone insulin lispro 0.2U/Kg, BioChaperone insulin lispro 0.1U/Kg and BioChaperone insulin lispro 0.4U/Kg
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
38 participants
Where
1 siteGermany
Study dates
May 2014to Dec 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 64 years
  • Men only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Profil Institut für stoffwechselforschung GmbH

    Neuss, 41460

Other trials in Germany

About this study

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®.

Read more

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.

Being tested
BioChaperone insulin lispro 0.2U/Kg, BioChaperone insulin lispro 0.1U/Kg, BioChaperone insulin lispro 0.4U/Kg, Humalog®
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BioChaperone insulin lispro 0.2U/KgDrug

    Single dose of 0.2U/Kg body weight injected subcutaneously

  • BioChaperone insulin lispro 0.1U/KgDrug

    Single dose of 0.1U/Kg body weight injected subcutaneously

  • BioChaperone insulin lispro 0.4U/KgDrug

    Single dose of 0.4U/Kg body weight injected subcutaneously

  • Humalog®Drug

    Single dose of 0.2U/Kg body weight injected subcutaneously

Study groups in NCT02146651
Study groupRoleWhat they receive
BioChaperone insulin lispro 0.2U/KgExperimentalBioChaperone insulin lispro 0.2U/Kg
Receives: 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/KgExperimentalBioChaperone insulin lispro 0.1U/Kg
Receives: 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/KgExperimentalBioChaperone insulin lispro 0.4U/Kg
Receives: 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/KgActive comparatorHumalog® 0.2U/Kg
Receives: Drug: BioChaperone insulin lispro 0.2U/Kg; Drug: BioChaperone insulin lispro 0.1U/Kg; Drug: BioChaperone insulin lispro 0.4U/Kg; Drug: Humalog®

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 12 hours

  2. Glucodynamic endpoint: GIRMax

    Maximum Glucose Infusion Rate

    Measured: 12 hours

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

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

    Measured: 12 hours

  4. Pharmacokinetic endpoint: Cmax(Lisp)

    Maximum observed serum insulin lispro concentration

    Measured: 12 hours

Secondary outcomes (4)

  1. Pharmacokinetics: Tmax(lisp)

    Time to maximum observed serum insulin lispro concentration

    Measured: 12 hours

  2. Glucodynamic: TGIRmax

    Time to maximum Glucose Infusion Rate

    Measured: 12 hours

  3. Tonset of action

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

    Measured: 12 hours

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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2014 (estimated)
  2. Study startMay 2014
  3. Primary completionJul 2014
  4. Study completionDec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
38 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146651
Sponsor's protocol ID
BC3-CT008
Status last verified
May 2014
First submitted
20 May 2014
Last updated
10 Dec 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BioChaperone insulin lispro 0.2U/Kg, BioChaperone insulin lispro 0.1U/Kg and BioChaperone insulin lispro 0.4U/Kg in people with Diabetes Mellitus Type 1, run by Adocia at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Glucodynamic endpoint: Area Under the Curve GIR(0-last) (time frame: 12 hours). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02146651.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Dec 2014.

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