ICH GCP | Clinical Trials Registry

Geropharm 

No

No

Inclusion Criteria: - Signed written consent - Clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening - Glycosylated hemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive) - Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive) - Stable doses OADs for at least 3 months prior to treatment of experimental drug - 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: - 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.) - Contraindication to the use of insulin Lispro Biphasic 25 - Insulin resistance over 1.5 U/kg insulin pro day - Presence of insulin antibodies in the blood at the screening ˃10 U/ml - Use of 3 or more oral antidiabetic drugs (OAD) - Presence of severe diabetes complications - History or presence of uncontrolled diabetes mellitus for 6 months prior to screening - Deviation of vital signs, which can influence to results - History of administration of glucocorticoids for 1 year prior to screening - History of autoimmune disease, except controlled autoimmune thyroid disease - Pregnant and breast-feeding women - 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 - Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexatum) - Incomplete recovery after surgery procedure

All

18 Years

65 Years

No

Russian Federation

Sponsor

No

Randomized

Parallel Assignment

Treatment

None (Open Label)