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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

Tracking Information
First Submitted Date  ICMJE August 8, 2014
First Posted Date  ICMJE August 11, 2014
Last Update Posted Date June 1, 2017
Study Start Date  ICMJE August 2014
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02213146 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 8, 2014)
  • 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
  • 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
  • Glucodynamics: Early t0.5 Glucose Infusion Rate max (GIRmax) [ Time Frame: 10 hours ]
    Time to first observed half maximum glucose infusion rate
  • Glucodynamics: GIRmax - Maximum glucose infusion rate [ Time Frame: 10 hours ]
    Maximum glucose infusion rate
  • 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
  • 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
  • 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
  • Pharmacokinetics: Cmax(ins/lisp) [ Time Frame: up to 10 hours ]
    Maximum observed human insulin / insulin lispro serum concentration
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus Type 1
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: BioChaperone human insulin
    BioChaperone Human Insulin
    Interventions:
    • Drug: BioChaperone human insulin
    • Drug: Huminsulin® Normal
    • Drug: Humalog®
  • Active Comparator: Human insulin
    Huminsulin® Normal
    Interventions:
    • Drug: BioChaperone human insulin
    • Drug: Huminsulin® Normal
    • Drug: Humalog®
  • Active Comparator: Insulin lispro
    Humalog®
    Interventions:
    • Drug: BioChaperone human insulin
    • Drug: Huminsulin® Normal
    • Drug: Humalog®
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 16, 2015)
38
Original Estimated Enrollment  ICMJE
 (submitted: August 8, 2014)
36
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date December 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02213146
Other Study ID Numbers  ICMJE BC3-CT010
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Adocia
Study Sponsor  ICMJE Adocia
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Grit Andersen, MD Profil GmbH
PRS Account Adocia
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP