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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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ClinicalTrials.gov Identifier: NCT01981031
Recruitment Status : Completed
First Posted : November 11, 2013
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Adocia

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.


Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: BioChaperone® Combo Drug: Humalog® Mix25 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Phase 1 Study to Assess the Efficacy and Safety of BioChaperone® Combo and Humalog® Mix 25 in Subjects With Type 1 Diabetes
Study Start Date : November 2013
Actual Primary Completion Date : December 2013
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
U.S. FDA Resources

Arm Intervention/treatment
Experimental: A
Drug: BioChaperone® Combo
Drug: BioChaperone® Combo
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)
Active Comparator: B
Drug: Humalog® Mix25
Drug: Humalog® Mix25
Single dose of 0.8U/kg body weight injected subcutaneously (under the skin)



Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01981031


Locations
Germany
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia

Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT01981031     History of Changes
Other Study ID Numbers: BC3-CT005
First Posted: November 11, 2013    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: September 2014

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Insulin, Isophane
Biphasic Insulins
Hypoglycemic Agents
Physiological Effects of Drugs