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Type 1 Diabetes MellitisPhase 3NCT07070752

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

A Phase 3 study testing GP40321, Apidra® SoloStar® and RinGlar® in people with Type 1 Diabetes Mellitis, run by Geropharm at 17 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 1 Diabetes Mellitis
What is being tested?
GP40321, Apidra® SoloStar® and RinGlar®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
17 sitesRussia
Study dates
14 Apr 2023to 28 Nov 2023
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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:
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  • 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.

Who cannot join

  • 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.
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  • 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.).
  • Acute T1DM complications within 3 months prior to Screening or identified during screening, including:
  • Episode of severe hypoglycemia (which required the help of another person or hospitalization);
  • Episode of diabetic ketoacidosis;
  • Episode of hyperosmolar hyperglycemic state.
  • More than 15 episodes of mild hypoglycemia (symptomatic or asymptomatic) within 1 month prior to Screening or identified during screening.
  • Related to comorbidities and subject health risk
  • Conditions affecting hemoglobin level assessment (e.g., history of hemoglobinopathy or hemolytic anemia, blood transfusion within 3 months prior to Screening); anemia that cannot be corrected before subject enrollment.
  • Significant blood loss within 3 months prior to Screening, including but not limited to:
  • Blood donation;
  • Extensive surgery or trauma resulting in significant blood loss.
  • Abnormal results of the following screening laboratory tests:
  • hemoglobin level <9.0 g/dL (SI system: <90 g/L);
  • hematocrit <30%;
  • ALT or AST >2 upper limits of normal (ULN) or either ALT or AST >3× ULN;
  • serum bilirubin level >2 ULN (excluding subjects with previously diagnosed Gilbert's syndrome).
  • History of or clinically significant condition identified during screening, including but not limited to:
  • Unstable angina, myocardial infarction, arrhythmia requiring medical treatment, or congestive heart failure class III or IV according to the New York Heart Association (NYHA) classification within 1 year prior to the Screening Visit;
  • Stroke or transient ischemic attack within 6 months prior to the Screening Visit.
  • Pregnancy or breastfeeding.
  • Related to immunogenicity assessment
  • Regular use of immunotropic therapy or any other medications that may affect the patient's immune status.
  • Vaccination within 3 months prior to the anticipated randomization date or planned during the study period.
  • History of autoimmune diseases other than vitiligo and controlled autoimmune diseases that are part of autoimmune polyglandular syndrome (types 1-3), with the exception of adrenal insufficiency.
  • A burdened allergic history, which, according to the Investigator, may affect the results of the study or endanger the patient's safety.
  • Full recovery from an acute inflammatory illness less than 4 weeks before the Screening Visit.
  • Incomplete recovery from surgery or surgical intervention planned for the period of the patient's participation in the study.
  • Positive serological test results for infections:
  • Human immunodeficiency virus (HIV-1/2 antibodies);
  • Hepatitis B (surface antigen);
  • Hepatitis C (antibodies to hepatitis C virus antigens).
  • History or presence of oncological and/or oncohematological diseases not in full 5-year remission at the Screening Visit.
  • History of organ and/or bone marrow transplantation (except for corneal transplantation performed ≥3 months prior to Screening).
  • Related to risk of protocol non-compliance
  • Planned hospitalization for any reason during the study period.
  • Mental, physical, or other conditions that prevent the subject from adequately assessing their behavior or properly complying with the study protocol, including a history of mental illness.
  • Current or past (within three years prior to the first administration of the investigational product) history of alcohol, drug, medication, and/or substance abuse.
  • Participation in another clinical study within 28 days prior to Screening or planned participation during the current study.
  • Any other conditions that, in the opinion of the Investigator, represent a contraindication for study participation (i.e., may adversely affect the subject's condition if they participate, may interfere with study procedures, or affect the interpretation of study results). In case of doubt, the Investigator should consult the Medical Expert for the study.

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

Russia17 sites

  • RZD-Medicine Clinical Hospital of Chelyabinsk

    Chelyabinsk, 454091

  • Interregional Clinical and Diagnostic Center

    Kazan', 420101

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

    Krasnoyarsk, 660041

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

    Moscow, 117292

  • "Endocrinological Dispensary of the Moscow City Health Department"

    Moscow, 119034

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

    Saint Petersburg, 194156

  • X7 Research, LLC

    Saint Petersburg, 194156

  • City Multidisciplinary Hospital No. 2

    Saint Petersburg, 194354

  • "City polyclinic No. 117"

    Saint Petersburg, 194358

  • St. Elizabeth City Hospital of the Holy Martyr

    Saint Petersburg, 195257

  • "City polyclinic No. 112"

    Saint Petersburg, 195297

  • "City polyclinic No. 112"

    Saint Petersburg, 195427

  • "Eco-Safety" Research Center, LLC

    Saint Petersburg, 196143

  • City Pokrovskaya Hospital

    Saint Petersburg, 199106

  • "City polyclinic No. 4"

    Saint Petersburg, 199178

  • "Diabetes Center", LLC

    Samara, 443041

  • Volgograd Regional Clinical Hospital No. 1

    Volgograd, 400081

Other trials in Russia

About this study

Official title: Multicenter, Open-Label, Randomized, Controlled Study of Non-Inferior Immunogenicity of GP40321 (Solution for Subcutaneous Injection, 100 U/mL; GEROPHARM LLC, Russia) and Apidra® SoloStar® (Solution for Subcutaneous Injection, 100 U/mL; Sanofi-Aventis Deutschland GmbH, Germany) in Type 1 Diabetes Mellitus Patients

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.
Being tested
GP40321, Apidra® SoloStar®, RinGlar®

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GP40321Drug

    Also called insulin glulisine

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

  • Apidra® SoloStar®Drug

    Also called insulin glulisine

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

  • RinGlar®Drug

    Also called insulin glargine

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

Study groups in NCT07070752
Study groupRoleWhat they receive
GP40321ExperimentalNot described
Receives: Drug: GP40321; Drug: RinGlar®
Apidra® SoloStar®Active comparatorNot described
Receives: Drug: Apidra® SoloStar®; Drug: RinGlar®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Proportion of patients who develop an immune response

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

    Measured: From screening to the end of treatment at Week 26

Secondary outcomes (14)

  1. Change in mean anti-insulin antibodies (AIA) level

    Change in mean anti-insulin antibodies (AIA) level after 26 weeks compared with baseline at Screening.

    Measured: From screening to the end of treatment at Week 26

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

    Change in mean neutralizing anti-insulin antibodies (nAIA) level after 26 weeks compared with baseline at Screening.

    Measured: From screening to the end of treatment at Week 26

  3. Incidence of nAIA in nAIA-naïve subjects

    Incidence of nAIA during 26 weeks of insulin therapy in nAIA-naïve subjects.

    Measured: From screening to the end of treatment at Week 26

  4. Proportion of patients with clinically significant immune response

    Proportion of patients who develop a clinically significant immune response within 26 weeks.

    Measured: From screening to the end of treatment at Week 26

  5. Change in mean HbA1c level

    Change in mean HbA1c level after 26 weeks compared with baseline at Screening.

    Measured: From screening to the end of treatment at Week 26

  6. Proportion of patients with HbA1c ≤7.0%

    Proportion of patients with HbA1c ≤7.0% in the absence of nocturnal and severe hypoglycemia after 26 weeks.

    Measured: From screening to the end of treatment at Week 26

  7. Proportion of patients with reached individual target HbA1c

    Proportion of patients who reach their individual target HbA1c after 26 weeks.

    Measured: From screening to the end of treatment at Week 26

  8. Change in mean fasting plasma glucose (FPG)

    Change in mean fasting plasma glucose (FPG) after 26 weeks compared with baseline at Screening.

    Measured: From screening to the end of treatment at Week 26

  9. Change in mean values of the 7-point glycemic profile

    Change in mean values of the 7-point glycemic profile after 22 weeks of stable-dose insulin therapy compared with baseline at Screening.

    Measured: From screening to the end of treatment at Week 26

  10. Change in mean values of the 7-point glycemic profile

    Change in mean values of the 7-point glycemic profile after 22 weeks of stable-dose insulin therapy compared with the end of the titration period.

    Measured: From the end of the dose titration period to the end of treatment at Week 26

  11. Change in mean total daily insulin dose

    Change in mean total daily insulin dose after 22 weeks of stable-dose insulin therapy compared with the end of the titration period.

    Measured: From the end of the dose titration period to the end of treatment at Week 26

  12. Change in mean body weight

    Change in mean body weight at Week 26 compared with baseline at Screening.

    Measured: From screening to the end of treatment at Week 26

  13. Treatment satisfaction

    Assessment of satisfaction with diabetes mellitus treatment using the DTSQs questionnaire after 26 weeks.

    Measured: From screening to the end of treatment at Week 26

  14. Assessment of safety

    • Frequency and severity of adverse events (AE)/serious adverse events (SAE) based on abnormalities in vital signs, ECG readings, and laboratory tests. -Separate assessment of the following AE/SAE: a. the frequency of hypoglycemia; b. the frequency of ketoacidosis; c. the frequency of injection site reactions; d. the frequency of allergic reactions. - Changes in vital signs compared to baseline. - Changes in laboratory test results compared to baseline.

    Measured: From screening to the end of treatment at Week 26

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2025
  2. Study start14 Apr 2023
  3. Primary completion28 Nov 2023
  4. Study completion28 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
224 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07070752
Sponsor's protocol ID
GP40321-P4-03-01
Status last verified
Jul 2025
First submitted
9 Jul 2025
Last updated
22 Jul 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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. 2026 Mar;28(3):1791-1799. doi: 10.1111/dom.70360. Epub 2025 Dec 9.

    PubMed 41366610

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP40321, Apidra® SoloStar® and RinGlar® in people with Type 1 Diabetes Mellitis, run by Geropharm at 17 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of patients who develop an immune response (time frame: From screening to the end of treatment at Week 26). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07070752, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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