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

Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01981031

Enrollment

Registered

2013-11-11

Start date

2013-11-30

Completion date

2014-08-31

Last updated

2017-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief 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.

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)

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

MALE

Age

18 Years to 64 Years

Healthy volunteers

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

* 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Compare pharmacodynamics and pharmacokinetics profiles between BioChaperone® Combo and Humalog® Mix25	from 0 to 30 hours after a single-dose administration	—
Number of Adverse Events	Weeks 0-10	hypoglycemic events, local tolerability, adverse reactions

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026