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

NCT07070752 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 224

Last updated 2025-07-22

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Geropharm

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-14
Primary Completion
2023-11-28
Completion
2023-11-28

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070752 on ClinicalTrials.gov