Status:
COMPLETED
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
Lead Sponsor:
Adocia
Conditions:
Diabetes Mellitus Type 1
Eligibility:
MALE
18-64 years
Phase:
PHASE1
PHASE2
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 sub...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2015
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02213146
Start Date
August 1 2014
End Date
June 1 2015
Last Update
June 1 2017
Active Locations (1)
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1
Profil GmbH
Neuss, Germany, 41460