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Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal

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ClinicalTrials.gov Identifier: NCT02344992
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : June 1, 2017
Sponsor:
Information provided by (Responsible Party):
Adocia

Study Description
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Brief Summary:

The addition of BioChaperone to already marketed prandial insulin analogue accelerates the onset and shorten the duration of action of insulin lispro due to facilitation of the absorption of the insulin after subcutaneous injection.

This trial is intented to compare the post-prandial blood glucose control of BioChaperone insulin lispro and Humalog® when injected after a standardized meal as well as the pharmacokinetic profile of BioChaperone insulin lispro and Humalog® in subjects with type 1 diabetes mellitus.

This is a double-blinded, randomized, controlled, two-period crossover phase Ib trial to compare the blood glucose control after ingestion of a standardized meal, with BioChaperone Lispro at 0.2U/Kg and Humalog at 0.2U/Kg.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus Type 1 Drug: BioChaperone insulin lispro Drug: Humalog® Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Study Start Date : January 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Arms and Interventions
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Arm Intervention/treatment
Experimental: Biochaperone Insulin Lispro Drug: BioChaperone insulin lispro
Single dose of 0.2 U/kg body weight injected subcutaneously
Active Comparator: Humalog® Drug: Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously


Outcome Measures
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Primary Outcome Measures :
  1. Area under the blood glucose time curve: AUCbg(0-2h) [ Time Frame: 2 hours ]
    Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal


Secondary Outcome Measures :
  1. Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h) [ Time Frame: 8 hours ]
  2. Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax [ Time Frame: 8 hours ]
  3. Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h) [ Time Frame: 8 hours ]
  4. Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp) [ Time Frame: 8 hours ]
  5. Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters [ Time Frame: Up to 7 weeks ]

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

Inclusion Criteria:

  • Type 1 Diabetes Mellitus ≥ 12 months
  • Treated with multiple daily insulin injections or CSII ≥ 12 months
  • BMI 18.5-28.0 kg/m² (both inclusive)
  • HbA1C%≤9%

Exclusion Criteria:

  • Type 2 Diabetes Mellitus
  • Receipt of any trial product within 60 days prior to this trial
  • Clinically significant abnormal haematology, biochemistry, lipids or urinalysis screening tests as judged by the investigator considering the underlying disease
  • Presence of clinically significant acute gastroinstestinal symptoms as judged by the investigator
  • Known slowing of gastric emptying and or gastrointestinal surgery that in the opinion of the investigator might change gastrointestinal motility and food absorption.
  • Any systemic treatment with drugs known to interfere with glucose metabolism
  • Use of any tobacco or nicotine-contained product within one year prior to screening
Contacts and Locations
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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): NCT02344992


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
More Information
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Responsible Party: Adocia
ClinicalTrials.gov Identifier: NCT02344992    
Other Study ID Numbers: BC3-CT011
2014-005028-92 ( EudraCT Number )
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: June 1, 2017
Last Verified: June 2015
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs