Diabetes Mellitus, Type 2
Conditions
Keywords
diabetes mellitus, insulin
Brief summary
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.
Interventions
BIOLOGICALInsulin Humulin® NPH
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
BIOLOGICALInsulin Rinsulin® NPH
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 No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Antibody Response | 24 weeks | Change from baseline in titer of antibodies to human insulin |
Secondary
| Measure | Time frame |
|---|---|
| Change in basal insulin dose per body weight (U/kg) from baseline | 24 weeks |
| Change in total basal insulin dose (U) from baseline | 24 weeks |
| Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency | 28 weeks (4 + 24 weeks) |
| Change in fasting plasma glucose level from baseline | 4 weeks |
| Occurrence of adverse events | 28 weeks (4 + 24 weeks) |
| Occurrence of Injection Site Reaction | 28 weeks (4 + 24 weeks) |
| Change in HbA1c from baseline | 24 weeks |
| Change in BMI from baseline | 24 weeks |
Countries
Russia
Outcome results
None listed