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

Geropharm

Status and phase

Completed

Phase 3

Conditions

Diabetes Mellitus, Type 1

Diabetes Mellitus

Treatments

Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution

Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution

Study type

Interventional

Funder types

Industry

Identifiers

NCT04022993

GLARGIN-IM

Details and patient eligibility

About

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

Enrollment

180 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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