Status:
COMPLETED
Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Geropharm
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 20 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 24 2018
Estimated Enrollment :
201 Patients enrolled
Trial Details
Trial ID
NCT04012775
Start Date
April 20 2017
End Date
September 24 2018
Last Update
July 9 2019
Active Locations (14)
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1
Chelyabinsk Railway Clinical Hospital
Chelyabinsk, Russia, 454000
2
Moscow Endocrinological Dispensary
Moscow, Russia, 119034
3
Moscow Clinical Hospital № 71
Moscow, Russia, 121374
4
Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, Russia, 603126