Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

264

Participants

Timeline

Start Date

June 3, 2019

Primary Completion Date

January 21, 2020

Study Completion Date

January 21, 2020

Conditions
DiabetesDiabetes Mellitus, Type 1
Interventions
DRUG

GP40071

GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.

DRUG

NovoRapid® Penfill®

NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.

Trial Locations (14)

117036

Endocrinology Research Centre (Moscow), Moscow

163045

Arkhangelsk Regional Clinical Hospital, Arkhangelsk

190013

Polyclinic Сomplex, Saint Petersburg

194354

City Diagnostic Center № 1, Saint Petersburg

194358

City Polyclinic № 117, Saint Petersburg

195197

EosMed, Saint Petersburg

196084

Institute of Medical Research, Saint Petersburg

197341

Almazov National Medical Research Centre, Saint Petersburg

199106

Pokrovskaya Municipal Hospital, Saint Petersburg

344022

Rostov State Medical University, Rostov-on-Don

410030

Clinical City Hospital № 9, Saratov

420073

Kazan Endocrinology Dispensary, Kazan'

443067

Diabetes Center, Samara

660022

Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky, Krasnoyarsk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Geropharm

INDUSTRY