Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients

An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients

The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.

Inclusion Criteria:

• Signed written consent
• Diabetes mellitus type 2
• Indications for Rinsulin NPH / Humalog NPH treatment
• Glycosylated 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).
• Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion.

Exclusion Criteria:

• Age less than 18 years old at screening
• Pregnant and breast-feeding women
• Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
• Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
• Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening.
• 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 hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.).
• History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
• Presence of severe diabetes complications
• Receipt of another investigational drug in the 3 months prior to screening
• Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening
• History or presence of drug abuse
• Positive test for addictive substance in urine at screening