NCT04226105 - Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients | Biotech Hunter

Enrollment

264

Participants

Timeline

Start Date

January 20, 2020

Primary Completion Date

September 30, 2020

Study Completion Date

December 25, 2020

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Interventions

DRUG

GP40081

1 ml of the GP40081 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.

DRUG

NovoMix 30

1 ml of the NovoMix 30 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.

Trial Locations (14)

163045

Arkhangelsk Regional Clinical Hospital, Arkhangelsk

185000

V.A. Baranov Republic Hospital, Petrozavodsk

194354

City Diagnostic Center № 1, Saint Petersburg

City Hospital № 2, Saint Petersburg

194358

City Polyclinic № 117, Saint Petersburg

195197

EosMed, Saint Petersburg

196084

Institute of Medical Research, Saint Petersburg

196143

Research Center Eco-Safety, Saint Petersburg

197341

Almazov National Medical Research Centre, Saint Petersburg

199106

Pokrovskaya Municipal Hospital, Saint Petersburg

400081

Volgograd Region Clinical Hospital №1, Volgograd

420073

Kazan Endocrinology Dispensary, Kazan'

443067

Diabetes Center, Samara

660022

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