Completed

Comparing Efficacy and Safety of Rinsulin® NPH and Humulin® NPH in Type 2 Diabetes Mellitus Patients

Study Aim

This study aims to compare the effectiveness and safety of Rinsulin® NPH versus Humulin® NPH in patients with Type 2 Diabetes Mellitus, focusing on the change in antibody response to human insulin from the beginning of the study.

What is being tested

Insulin Humulin® NPH

+ Insulin Rinsulin® NPH

Biological

Who is being recruted

Diabetes Mellitus+5

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

Over 18 Years

+19 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Phase 3

Interventional

Study Start: April 2017

See protocol details

Summary

Principal SponsorGeropharm

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: April 20, 2017

Actual date on which the first participant was enrolled.

This clinical trial focuses on comparing the effectiveness and safety of two insulin treatments, Rinsulin® NPH by Geropharm (Russia) and Humulin® NPH by Lilly France (France), for patients with Type 2 Diabetes Mellitus. The goal is to confirm if Rinsulin® NPH is as good as or better than Humulin® NPH. This research is important as it could potentially offer a new treatment option for individuals living with Type 2 diabetes, addressing the need for effective and safe insulin therapies. During the trial, participants receive either Rinsulin® NPH or Humulin® NPH. The study measures the body's response to these treatments by evaluating changes in the level of antibodies to human insulin from the start to the end of the trial. This helps determine how well each treatment works and assesses any potential side effects.

Official TitleAn 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

NCT04012775

Principal SponsorGeropharm

Last updated: January 27, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

201 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesHyperinsulinismInsulin ResistanceMetabolic DiseasesNutritional and Metabolic DiseasesGlucose Metabolism Disorders

Criteria

6 inclusion criteria required to participate

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)

Show More Criteria

13 exclusion criteria prevent from participating

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)

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Active Comparator

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

Group II

Experimental

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 14 locations

Suspended

Chelyabinsk Railway Clinical Hospital

Chelyabinsk, RussiaOpen Chelyabinsk Railway Clinical Hospital in Google Maps

Suspended

Moscow Endocrinological Dispensary

Moscow, Russia

Suspended

Moscow Clinical Hospital № 71

Moscow, Russia

Suspended

Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, Russia

Completed14 Study Centers