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
NCT ID: NCT02213146
Last Updated: 2017-06-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2014-08-31
2015-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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BioChaperone human insulin
BioChaperone Human Insulin
BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously
Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously
Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously
Human insulin
Huminsulin® Normal
BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously
Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously
Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously
Insulin lispro
Humalog®
BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously
Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously
Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously
Interventions
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BioChaperone human insulin
Single dose of 0.2 U/kg body weight injected subcutaneously
Huminsulin® Normal
Single dose of 0.2 U/kg body weight injected subcutaneously
Humalog®
Single dose of 0.2 U/kg body weight injected subcutaneously
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
64 Years
MALE
No
Sponsors
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Adocia
INDUSTRY
Responsible Party
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Principal Investigators
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Grit Andersen, MD
Role: PRINCIPAL_INVESTIGATOR
Profil GmbH
Locations
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Profil GmbH
Neuss, , Germany
Countries
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Other Identifiers
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BC3-CT010
Identifier Type: -
Identifier Source: org_study_id
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