Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients

NCT ID: NCT04022993

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-04
• Study Completion Date: 2019-05-15

Brief Summary

The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Lantus® SoloStar®

Lantus® SoloStar® once a day, individually glucose-level based administered in stable doses, started before enrollement

Group Type: ACTIVE_COMPARATOR

Lantus Solostar, 100 Units/mL Subcutaneous Solution

Intervention Type: DRUG

4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

Insulin RinGlar®

Insulin RinGlar® once a day, individually glucose-level based administered in stable doses, started before enrollement

Group Type: EXPERIMENTAL

Insulin RinGlar, 100 Units/mL Subcutaneous Solution

Intervention Type: DRUG

4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

Interventions

Lantus Solostar, 100 Units/mL Subcutaneous Solution

4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

Intervention Type: DRUG

Insulin RinGlar, 100 Units/mL Subcutaneous Solution

4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Signed written consent
• Diabetes mellitus type 1 for at least 12 months prior to screening
• History of basis-bolus (multiple dose injection (MDI)) therapy in stable doses at least 30 days
• Glycated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
• Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive)
• Subject is able and willing to comply with the requirements of the study protocol

Exclusion Criteria

• Contraindication to the use of Insulin glargine
• Insulin resistance over 1.5 U/kg insulin pro day
• History of treatment any biosimilar insulin
• History of treatment any experimental drugs or medical devices for 3 months prior to screening
• History of treatment insulin pump for 90 days prior to signed written consent or indication for use insulin pump
• Presence of severe diabetes complications
• History of severe hypoglycemia during 6 months prior to signed written consent
• History of 15 or more episodes mild hypoglycemia during 1 month prior to signed written consent
• History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
• History of administration of glucocorticoids for 1 year prior to screening
• Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum, etc.)
• History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency
• History of hypersensitivity to any of the active or inactive ingredients of the insulin/insulin analogue preparations used in the trial, OR history of significant allergic drug reactions
• History of severe allergic reactions
• Pregnant and breast-feeding women
• Acute inflammation disease for 3 weeks prior to screening
• Deviation of the laboratory results conducted during the screening:

Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value

• History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.)
• Serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.)
• Incomplete recovery after surgery procedure
• History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year prior to screening
• History of stroke or TIA for 6 months prior to screening
• History of drug, alcohol abuse for 3 years prior to screening
• Inability follow to protocol
• History of oncological disease during 5 years prior to screening
• Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at screening.
• History of transplantation, except 3 months after corneal transplant
• History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geropharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tatyana L Karonova, MD, DSc

Role: PRINCIPAL_INVESTIGATOR

Almazov National Medical Research Centre

Locations

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, , Russia

Kazan Endocrinology Dispensary

Kazan', , Russia

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

Krasnoyarsk, , Russia

Endocrinology Research Centre (Moscow)

Moscow, , Russia

V.A. Baranov Republic Hospital

Petrozavodsk, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

Polyclinic Сomplex

Saint Petersburg, , Russia

City Diagnostic Center № 1

Saint Petersburg, , Russia

City Hospital № 2

Saint Petersburg, , Russia

City Polyclinic № 117

Saint Petersburg, , Russia

EosMed

Saint Petersburg, , Russia

Almazov National Medical Research Centre

Saint Petersburg, , Russia

Pokrovskaya Municipal Hospital

Saint Petersburg, , Russia

Clinical City Hospital № 9

Saratov, , Russia

Countries

Russia

References

Karonova TL, Mosikian AA, Mayorov AY, Makarenko IE, Zyangirova ST, Afonkina OA, Belikova TM, Zalevskaya AG, Khokhlov AL, Drai RV. Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus(R)): a randomized open-label clinical trial. J Comp Eff Res. 2020 Mar;9(4):263-273. doi: 10.2217/cer-2019-0136. Epub 2020 Feb 6.

Reference Type: DERIVED

PMID: 32027167 (View on PubMed)

Other Identifiers

GLARGIN-IM

Identifier Type: -

Identifier Source: org_study_id