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A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02213146
Recruitment Status : Completed
First Posted : August 11, 2014
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Adocia

Brief Summary:

The addition of BioChaperone to already marketed prandial human insulin preparations may accelerate the onset and shorten the duration of action due to facilitation of the insulin absorption after subcutaneous injection.

The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in subjects with type 1 diabetes under a dose of 0.2 U/kg.

This trial is a single center, randomised, double-blinded, three treatment, three-period cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3 separate dosing visits.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Drug: BioChaperone human insulin Drug: Huminsulin® Normal Drug: Humalog® Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Study Start Date : August 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: BioChaperone human insulin
BioChaperone Human Insulin
Drug: BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously

Drug: Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously

Drug: Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously

Active Comparator: Human insulin
Huminsulin® Normal
Drug: BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously

Drug: Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously

Drug: Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously

Active Comparator: Insulin lispro
Humalog®
Drug: BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously

Drug: Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously

Drug: Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously




Primary Outcome Measures :
  1. Area under the curve (AUCins(0-1h)) [ Time Frame: 1 hour ]
    Area under the human insulin serum concentration - time curve from t=0 to 1 hour


Secondary Outcome Measures :
  1. Pharmacokinetics: Early t0.5max ins/lisp [ Time Frame: up to 10 hours post administration ]
    Time to first observed half maximum serum human insulin / insulin lispro concentration

  2. Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 10 hours [ Time Frame: 10 hours ]
    Area under the glucose infusion rate - time curve from t=0 to 10 hours

  3. Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax) [ Time Frame: 10 hours ]
    Time to first observed half maximum glucose infusion rate

  4. Glucodynamics: GIRmax - Maximum glucose infusion rate [ Time Frame: 10 hours ]
    Maximum glucose infusion rate

  5. Pharmacokinetics: AUCins/lisp(0-10h): Area under the human insulin / insulin lispro serum concentration [ Time Frame: 10 hours ]
    Area under the human insulin / insulin lispro serum concentration - Time curve from t=0 to 10 hours

  6. Pharmacokinetics: Tmax(ins/lisp) - Time to maximum observed serum human insulin concentration and insulin lispro concentration [ Time Frame: 10 hours ]
    Time to maximum observed serum human insulin concentration and insulin lispro concentration

  7. Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters [ Time Frame: up to 7 weeks ]
    Adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

  8. Pharmacokinetics: Cmax(ins/lisp) [ Time Frame: up to 10 hours ]
    Maximum observed human insulin / insulin lispro serum concentration

  9. Glucodynamics: Area under the glucose infusion rate - time curve from t=0 to 2 hours [ Time Frame: 2 hours post administration ]
    Area under the glucose infusion rate - time curve from t=0 to 2 hours



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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:

  • Male subject with type 1 diabetes for at least 12 months
  • Treated with multiple daily insulin injections or insulin pump (CSII) for at least 12 months
  • Body mass index: 18.5-28.0 kg BW·m-2
  • HbA1c: ≤ 9.0%

Exclusion Criteria:

  • Diabetes mellitus type 2
  • Receipt of any investigational product within 3 months prior to first dosing of investigational product in this trial
  • 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 as per Investigator's judgement
  • Use of any tobacco or nicotine-contained product within one year 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): NCT02213146


Locations
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Germany
Profil GmbH
Neuss, Germany, 41460
Sponsors and Collaborators
Adocia
Investigators
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Principal Investigator: Grit Andersen, MD Profil GmbH

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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02213146     History of Changes
Other Study ID Numbers: BC3-CT010
First Posted: August 11, 2014    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: June 2015
Additional relevant MeSH terms:
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Insulin
Insulin, Globin Zinc
Insulin Lispro
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs