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

NCT07070752 | Completed Phase 3

• 1 other identifier: GP40321-P4-03-01
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 17

Brief Summary

The goal of this clinical trial is to demonstrate the non-inferior immunogenicity of GP40321 compared to Apidra® SoloStar® at a concentration of 100 U/mL in type 1 diabetes mellitus patients. The main questions it aims to answer are:

• What is the immunogenicity of GP40321 and Apidra® SoloStar®?
• What are the efficacy and safety of GP40321 and Apidra® SoloStar®? Researchers will compare the immunogenicity, efficacy and safety parameters of GP40321 and Apidra® SoloStar®. Participants will:
• Visit the clinic 9 times: once for screening, 3 times during dose titration (plus 2 telephone contacts) and 5 times during the stable dose treatment period.

Conditions

Type 1 Diabetes Mellitis

Outcome Measures

Primary Outcomes (1)

• Proportion of patients who develop an immune response

  The proportion of patients who develop an immune response during the study.

  From screening to the end of treatment at Week 26

Secondary Outcomes (14)

• Change in mean anti-insulin antibodies (AIA) level

  From screening to the end of treatment at Week 26

• Change in mean neutralizing anti-insulin antibodies (nAIA) level

  From screening to the end of treatment at Week 26

• Incidence of nAIA in nAIA-naïve subjects

  From screening to the end of treatment at Week 26

• Proportion of patients with clinically significant immune response

  From screening to the end of treatment at Week 26

• Change in mean HbA1c level

  From screening to the end of treatment at Week 26

Study Arms (2)

GP40321

EXPERIMENTAL

Drug: GP40321; Drug: RinGlar®

Apidra® SoloStar®

ACTIVE COMPARATOR

Drug: Apidra® SoloStar®; Drug: RinGlar®

Interventions

GP40321 DRUG

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

Also known as: insulin glulisine

GP40321

Apidra® SoloStar® DRUG

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

Also known as: insulin glulisine

Apidra® SoloStar®

RinGlar® DRUG

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

Also known as: insulin glargine

Apidra® SoloStar®; GP40321

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent to participate in the study.
• Male or female sex.
• Age ≥18 years at the time of providing informed consent.
• Diagnosis of type 1 diabetes mellitus (T1DM) for ≥12 months prior to the Screening Visit.
• Body Mass Index (BMI) between 18.5-35.0 kg/m² at the Screening Visit.
• Stable basal-bolus insulin therapy for ≥6 months prior to the Screening Visit, including:
• Insulin glargine (100 U/mL)
• IN COMBINATION WITH
• Insulin aspart (100 U/mL) OR
• Insulin lispro (100 U/mL) OR
• Insulin glulisine (100 U/mL)
• HbA1c level ≥6.5% and ≤10%, measured at screening.
• Willingness and ability to comply with study procedures, including the 7-point glycemic profile and self-monitoring of blood glucose, as well as protocol-specified restrictions and prohibitions.

You may not qualify if:

• Related to Insulin Therapy
• Contraindications to insulin glulisine or insulin glargine therapy.
• History of hypersensitivity to any component of the investigational product or significant allergic reactions to medications, including any type of insulin.
• Severe insulin resistance (defined as insulin requirement \>1.5 U/kg/day).
• Change of the INN (International Nonproprietary Name) of bolus or basal insulin within 6 months prior to Screening.
• Use of biosimilar insulin products within 6 months prior to Screening, except for those from GEROPHARM LLC.
• Use of insulin pump therapy within 6 months prior to Screening or planned initiation during the study.
• Use of systemic glucocorticoids at supraphysiologic doses for ≥7 days within 3 months prior to Screening.
• Use of hypoglycemic drugs other than insulin products, including injectable glucagon-like peptide-1 receptor agonists (aGLP-1), within 3 months prior to Screening or planned initiation during the study.
• Related to T1DM progression and subject health risk
• History of or screening-identified chronic T1DM complications, including:
• Proliferative diabetic retinopathy, which may require intervention during the study period (laser ablation, surgical treatment, injectable drugs, etc.), in the opinion of the Investigator;
• Severe diabetic peripheral or autonomic neuropathy, in the opinion of the Investigator;
• Chronic kidney disease (including diabetic nephropathy) with an estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m²;
• Current diabetic foot syndrome that may require intervention during the study period (surgical treatment, wound rehabilitation, limb relief, adjuvant therapy, antibacterial therapy, etc.).

Sponsors & Collaborators

• Geropharm: lead

Study Sites (17)

RZD-Medicine Clinical Hospital of Chelyabinsk

Chelyabinsk, 454091, Russia

Location

Interregional Clinical and Diagnostic Center

Kazan', 420101, Russia

Location

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

Krasnoyarsk, 660041, Russia

Location

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

Moscow, 117292, Russia

Location

"Endocrinological Dispensary of the Moscow City Health Department"

Moscow, 119034, Russia

Location

Almazov National Medical Research Center of the Ministry of Health of the Russian Federation

Saint Petersburg, 194156, Russia

Location

X7 Research, LLC

Saint Petersburg, 194156, Russia

Location

City Multidisciplinary Hospital No. 2

Saint Petersburg, 194354, Russia

Location

"City polyclinic No. 117"

Saint Petersburg, 194358, Russia

Location

St. Elizabeth City Hospital of the Holy Martyr

Saint Petersburg, 195257, Russia

Location

"City polyclinic No. 112"

Saint Petersburg, 195297, Russia

Location

"City polyclinic No. 112"

Saint Petersburg, 195427, Russia

Location

"Eco-Safety" Research Center, LLC

Saint Petersburg, 196143, Russia

Location

City Pokrovskaya Hospital

Saint Petersburg, 199106, Russia

Location

"City polyclinic No. 4"

Saint Petersburg, 199178, Russia

Location

"Diabetes Center", LLC

Samara, 443041, Russia

Location

Volgograd Regional Clinical Hospital No. 1

Volgograd, 400081, Russia

Location

Related Publications (1)

• Drai R, Galstyan G, Karonova T, Protsenko E, Parfenova T, Arefeva A, Matvienko I, Iliushchenko D, Makarenko I. Immunogenicity, efficacy and safety of a biosimilar insulin glulisine compared with originator in adults with type 1 diabetes mellitus: A phase III randomised clinical trial. Diabetes Obes Metab. 2025 Dec 9. doi: 10.1111/dom.70360. Online ahead of print.

  PMID: 41366610 DERIVED

MeSH Terms

Interventions

insulin glulisine; Insulin Glargine

Intervention Hierarchy (Ancestors)

Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2025
• First Posted: July 17, 2025
• Study Start: April 14, 2023
• Primary Completion: November 28, 2023
• Study Completion: November 28, 2023
• Last Updated: July 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (17)