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NCT Number: NCT01981031

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

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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year–64 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Neuss, 41460, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Biochaperone® Combo

Drug

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

Humalog® Mix25

Drug

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

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

    Time frame: Weeks 0-10

    hypoglycemic events, local tolerability, adverse reactions

Sponsors and collaborators

Lead sponsor

Adocia

Industry

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2014
First posted
Nov 11, 2013
Registry last updated
Jun 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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