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

Primary Purpose

Diabetes Mellitus Type 1

Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
BioChaperone insulin lispro
Humalog®
Sponsored by
Adocia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus Type 1

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Profil GmbH

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Biochaperone Insulin Lispro

Humalog®

Arm Description

Outcomes

Primary Outcome Measures

Area under the blood glucose time curve: AUCbg(0-2h)
Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal

Secondary Outcome Measures

Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)
Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax
Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)
Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters

Full Information

First Posted
January 19, 2015
Last Updated
May 31, 2017
Sponsor
Adocia
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1. Study Identification

Unique Protocol Identification Number
NCT02344992
Brief Title
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Official Title
Blood Glucose Control With BioChaperone Insulin Lispro Compared to Insulin Lispro (Humalog®) After Ingestion of a Standardized Meal
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
January 2015 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Adocia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Biochaperone Insulin Lispro
Arm Type
Experimental
Arm Title
Humalog®
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
BioChaperone insulin lispro
Intervention Description
Single dose of 0.2 U/kg body weight injected subcutaneously
Intervention Type
Drug
Intervention Name(s)
Humalog®
Intervention Description
Single dose of 0.2 U/kg body weight injected subcutaneously
Primary Outcome Measure Information:
Title
Area under the blood glucose time curve: AUCbg(0-2h)
Description
Area under the blood glucose concentration time curve from 0-2 hours after a standardised meal
Time Frame
2 hours
Secondary Outcome Measure Information:
Title
Pharmacodynamic: Area under the blood glucose concentration time curve from 0-8 hours after a standardized meal: AUCbg(0-8h)
Time Frame
8 hours
Title
Pharmacodynamic: maximum blood glucose concentration after a standardized meal: BGmax
Time Frame
8 hours
Title
Pharmacokinetic: Area under the serum insulin lispro concentration time curve from 0-8hours: AUClisp(0-8h)
Time Frame
8 hours
Title
Pharmacokinetic: Maximum observed serum insulin lispro concentration: Cmax(lisp)
Time Frame
8 hours
Title
Safety and tolerability: adverse events, local tolerability, vital signs variation, ECG, laboratory safety parameters
Time Frame
Up to 7 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Grit Andersen, MD
Organizational Affiliation
Profil GmbH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Profil GmbH
City
Neuss
ZIP/Postal Code
41460
Country
Germany

12. IPD Sharing Statement

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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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