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

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

Official Title
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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

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Biological: Insulin Humulin® NPH
* Biological: Insulin Rinsulin® NPH


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin Humulin® NPH<br>Insulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment | Biological: Insulin Humulin® NPH<br>* 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses<br>|
| Experimental: Insulin Rinsulin® NPH<br>Insulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment | Biological: Insulin Rinsulin® NPH<br>* 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody Response | Change from baseline in titer of antibodies to human insulin | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency |  | 28 weeks (4 + 24 weeks) | 
| Change in BMI from baseline |  | 24 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 fasting plasma glucose level from baseline |  | 4 weeks | 
| Change in fasting plasma glucose level from baseline |  | 16 weeks | 
| Change in fasting plasma glucose level from baseline |  | 28 weeks | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes mellitus, insulin