Diabetes Mellitus, Type 2, Diabetes Mellitus
Conditions
Keywords
Diabetes Mellitus, Type 2, Lispro Biphasic, Insulin
Brief 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.
Interventions
DRUGHumalog Mix25
Subcutaneus injections Humalog® Mix 25 twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
DRUGInsulin Lispro Biphasic 25
Subcutaneus injections Insulin Lispro Biphasic 25 (Geropharm) twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Sponsors
Geropharm
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response | 26 weeks | Change from baseline in titer of antibodies to human insulin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | 26 weeks | Change in HbA1c from baseline |
| Fasting Plasma Glucose Level | 26 weeks | Change in fasting plasma glucose level from baseline |
| Seven-Point Glucose Testing | 26 weeks | Change in seven-point glucose testing results from baseline |
| Adverse Events frequency and degree | 26 weeks (4+22 weeks) | Hypoglycemic episodes (glucose level \< 3.9 mmol/l) frequency Occurrence of local reactions at injection sites Occurrence allergic reactions |
| Body Mass Index | 26 weeks | Change in BMI from baseline |
| Treatment Satisfaction | 26 weeks | Change in overall treatment satisfaction (DTSQ score) from baseline |
| Insulin Dose | 26 weeks | Change in total insulin dose per body weight (U/kg) from baseline |
Countries
Russia
Outcome results
None listed