Evaluation of Insulin Glulisine (GP40321) Compared to Insulin Glulisine (Apidra® SoloStar®) in Type 1 Diabetes Mellitus Patients

PHASE3CompletedINTERVENTIONAL
Enrollment

224

Participants

Timeline

Start Date

April 14, 2023

Primary Completion Date

November 28, 2023

Study Completion Date

November 28, 2023

Conditions
Type 1 Diabetes Mellitis
Interventions
DRUG

GP40321

GP40321, solution for subcutaneous injection, 100 U/mL (GEROPHARM LLC, Russia)

DRUG

Apidra® SoloStar®

Apidra® SoloStar®, solution for subcutaneous injection, 100 U/mL (Sanofi-Aventis Deutschland GmbH, Germany)

DRUG

RinGlar®

Patients also receive long-acting basal insulin therapy (insulin glargine 100 U/mL) throughout the study

Trial Locations (17)

117292

National Medical Research Center of Endocrinology of the Ministry of Health of the Russian Federation, Moscow

119034

"Endocrinological Dispensary of the Moscow City Health Department", Moscow

194156

Almazov National Medical Research Center of the Ministry of Health of the Russian Federation, Saint Petersburg

X7 Research, LLC, Saint Petersburg

194354

City Multidisciplinary Hospital No. 2, Saint Petersburg

194358

"City polyclinic No. 117", Saint Petersburg

195257

St. Elizabeth City Hospital of the Holy Martyr, Saint Petersburg

195297

"City polyclinic No. 112", Saint Petersburg

195427

"City polyclinic No. 112", Saint Petersburg

196143

"Eco-Safety Research Center, LLC", Saint Petersburg

199106

City Pokrovskaya Hospital, Saint Petersburg

199178

"City polyclinic No. 4", Saint Petersburg

400081

Volgograd Regional Clinical Hospital No. 1, Volgograd

420101

Interregional Clinical and Diagnostic Center, Kazan'

443041

"Diabetes Center, LLC", Samara

454091

RZD-Medicine Clinical Hospital of Chelyabinsk, Chelyabinsk

660041

Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky, Ministry of Health of the Russian Federation, Krasnoyarsk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Geropharm

INDUSTRY