Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

• Status: Completed
• Trial end date: 2019-04-18
• Target enrollment: 0
• Participant gender: All

Summary

The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Geropharm
• Treatments: Biphasic Insulins; Insulin; Insulin Lispro; Insulin, Globin Zinc; Insulin, Isophane

Criteria

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