Detail of the clinical trial

Title of the trial A 6-Month, Multicenter, Randomized, Open-label, Parallel-group study comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus Injected in the Morning or Evening in Patients with Type 1 Diabetes Mellitus with a 6-month safety extension Period
EudraCT number 2012-001524-35
Protocol number EFC12456
Sponsor sanofi-aventis recherche & development, 1 Avenue Pierre Brossolette, Chilly-Mazarin, 91385 France
Indications Diabetology
Diagnosis Type 1diabetes Mellitus
Population in clinical trial Adults (18-65 years)
Elderly ( > 65 years)
Year of receiving the request to Institute (SÚKL) 2012
Date of approval by Institute (SÚKL) 30.11.2012
Date of approval by EC 7.11.2012
Date of initiation CT in ČR 29.1.2013
Date of ending CT in ČR 4.4.2014
Sites ResTrial, s.r.o., Mazurská 484/2, Praha 8 181 00
FN u sv. Anny v Brně, 2. interní klinika, Pekařská 53, Brno 656 91
FN Brno, Diabetologické centrum, Jihlavská 20, Brno, 625 00
FNKV, II. interní klinika, diabetologie, Šrobárova 50, Praha 10 100 34

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