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

Launched by ADOCIA · Aug 8, 2014

Keywords

ClinConnect Summary

No description provided

Gender

MALE

Eligibility criteria

• 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