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CompletedNCT01981031Updated Jun 1, 2017

A Trial to Assess the Efficacy and Safety of BioChaperone Combo and Humalog Mix 25 in Subjects With Type 1 Diabetes

A Phase 1 interventional study of BioChaperone® Combo and Humalog® Mix25 in Diabetes and 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 2017-06-01.

Sponsored by Adocia · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
21
Allocation
Randomized
Ages
18 Years to 64 Years
Sex
Male
01

Study summary

BioChaperone Combo is a liquid formulation containing both Insulin Glargine and Insulin Lispro.

The aim of this trial is to assess the efficacy and safety of BioChaperone® Combo in subjects with type 1 diabetes under a dose of 0.8 U/kg.

This trial is a phase 1 single-center, randomized, double-blinded, two-treatment, two-period cross-over, 30-hour euglycaemic glucose clamp trial in subjects with type 1 diabetes mellitus. Each subject will be randomly allocated to one single dose of 0.8 U/kg of BioChaperone® Combo and to one single dose of 0.8 U/kg of Humalog® Mix 25 on two separate dosing visits.

02

Conditions studied

  • Diabetes
  • Diabetes Mellitus, Type 1
03

In context

Diabetes Mellitus

10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 21 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Adocia is the lead sponsor of 26 studies on the registry; none are open to participants now.

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

Inclusion criteria

  • Type 1 diabetes mellitus for at least (or equal to ) 12 months,
  • Treated with multiple daily insulin injections or insulin pump treatment for at least (or equal to) 12 months,
  • Body Mass Index (BMI): 18.0-28.0kg/m2 (both inclusive)

Exclusion criteria

Exclusion Criteria:

  • Type 2 diabetes mellitus,
  • The receipt of any investigational product within 3 month 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 and any tobacco product within 5 years 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 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
21 participants (actual)

Study arms

  • Experimental
    A

    Drug: BioChaperone® Combo

    Drug: BioChaperone® Combo

  • Active comparator
    B

    Drug: Humalog® Mix25

    Drug: Humalog® Mix25

Interventions

  • DrugBioChaperone® Combo

    Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

  • DrugHumalog® Mix25

    Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)

06

What researchers measure

Primary outcomes

  1. End of action of 0.8 U/kg BioChaperone® Combo (time from administration until blood glucose concentration is consistently above 8.3 mmol/L during the glucose clamp procedure)

    Time frame: from 0 to 30 hours after a single-dose administration

Secondary outcomes

  1. Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25

    Time frame: from 0 to 30 hours after a single-dose administration

  2. Number of Adverse Events

    hypoglycemic events, local tolerability, adverse reactions

    Time frame: Weeks 0-10

07

Study locations

1 site
  • Neuss, 41460, Germany
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 1, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01981031
Lead sponsor
Adocia
Responsible party
Sponsor
First posted
Nov 11, 2013
Start date
Nov 2013
Primary completion
Dec 2013
Completion
Aug 2014
Last update
Jun 1, 2017

Oversight

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

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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