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

Phase 3

Completed

• Conditions: Diabetes Mellitus, Type 2
• Interventions: Biological: Insulin Rinsulin® NPH; Biological: Insulin Humulin® NPH

• Registration Number: NCT04012775
• Lead Sponsor: Geropharm

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2017-04-20
• Primary Completion: 2018-09-24
• Study Completion: 2018-09-24
• Status Verified: 2019-01
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-08
• Last Update Submitted: 2019-07-08
• Study First Posted: 2019-07-09
• Last Update Posted: 2019-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Insulin Rinsulin® NPH	Insulin Rinsulin® NPH	Insulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment
Insulin Humulin® NPH	Insulin Humulin® NPH	Insulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment

Primary Outcome Measures

Name	Time	Method
Antibody Response	24 weeks	Change from baseline in titer of antibodies to human insulin

Secondary Outcome Measures

Name	Time	Method
Occurrence of adverse events	28 weeks (4 + 24 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
Change in fasting plasma glucose level from baseline	28 weeks
Change in BMI from baseline	24 weeks
Occurrence of Injection Site Reaction	28 weeks (4 + 24 weeks)
Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency	28 weeks (4 + 24 weeks)
Change in HbA1c from baseline	24 weeks

Trial Locations

Locations (14)

Moscow Endocrinological Dispensary; 🇷🇺 Moscow, Russian Federation

Nizhny Novgorod Regional Clinical Hospital; 🇷🇺 Nizhny Novgorod, Russian Federation

V.A. Baranov Republic Hospital; 🇷🇺 Petrozavodsk, Russian Federation

City Polyclinic № 17; 🇷🇺 Saint Petersburg, Russian Federation

Medical Sanitary Unit № 157; 🇷🇺 Saint Petersburg, Russian Federation

Saint Petersburg State Diagnostic Center № 85; 🇷🇺 Saint Petersburg, Russian Federation

Institute of Medical Research; 🇷🇺 Saint Petersburg, Russian Federation

Research Center Eco-Safety; 🇷🇺 Saint Petersburg, Russian Federation

Diabetes Center; 🇷🇺 Samara, Russian Federation

Clinical Hospital № 3; 🇷🇺 Yaroslavl, Russian Federation

Chelyabinsk Railway Clinical Hospital; 🇷🇺 Chelyabinsk, Russian Federation

Moscow Clinical Hospital № 71; 🇷🇺 Moscow, Russian Federation

City Polyclinic № 6; 🇷🇺 Saint Petersburg, Russian Federation

City Hospital № 2; 🇷🇺 Saint Petersburg, Russian Federation