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

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Adocia

Status and phase

Completed
Phase 1

Conditions

Diabetes Mellitus, Type 1
Diabetes

Treatments

Drug: Humalog® Mix25
Drug: BioChaperone® Combo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01981031
BC3-CT005

Details and patient eligibility

About

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.

Enrollment

21 patients

Sex

Male

Ages

18 to 64 years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

21 participants in 2 patient groups

A
Experimental group
Description:
Drug: BioChaperone® Combo
Treatment:
Drug: BioChaperone® Combo
B
Active Comparator group
Description:
Drug: Humalog® Mix25
Treatment:
Drug: Humalog® Mix25

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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