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

July 8, 2019 updated by: Geropharm

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
201

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Chelyabinsk, Russian Federation, 454000
        • Chelyabinsk Railway Clinical Hospital
      • Moscow, Russian Federation, 119034
        • Moscow Endocrinological Dispensary
      • Moscow, Russian Federation, 121374
        • Moscow Clinical Hospital № 71
      • Nizhny Novgorod, Russian Federation, 603126
        • Nizhny Novgorod Regional Clinical Hospital
      • Petrozavodsk, Russian Federation, 185000
        • V.A. Baranov Republic Hospital
      • Saint Petersburg, Russian Federation, 194354
        • City Hospital № 2
      • Saint Petersburg, Russian Federation, 196084
        • Institute of Medical Research
      • Saint Petersburg, Russian Federation, 196143
        • Research Center Eco-Safety
      • Saint Petersburg, Russian Federation, 192148
        • City Polyclinic № 6
      • Saint Petersburg, Russian Federation, 195176
        • City Polyclinic № 17
      • Saint Petersburg, Russian Federation, 196066
        • Medical Sanitary Unit № 157
      • Saint Petersburg, Russian Federation, 198260
        • Saint Petersburg State Diagnostic Center № 85
      • Samara, Russian Federation, 443067
        • Diabetes Center
      • Yaroslavl, Russian Federation, 150007
        • Clinical Hospital № 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

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

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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
Biological: Insulin Humulin® NPH
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Experimental: 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
Biological: Insulin Rinsulin® NPH
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Antibody Response
Time Frame: 24 weeks
Change from baseline in titer of antibodies to human insulin
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency
Time Frame: 28 weeks (4 + 24 weeks)
28 weeks (4 + 24 weeks)
Change in BMI from baseline
Time Frame: 24 weeks
24 weeks
Occurrence of adverse events
Time Frame: 28 weeks (4 + 24 weeks)
28 weeks (4 + 24 weeks)
Occurrence of Injection Site Reaction
Time Frame: 28 weeks (4 + 24 weeks)
28 weeks (4 + 24 weeks)
Change in HbA1c from baseline
Time Frame: 24 weeks
24 weeks
Change in fasting plasma glucose level from baseline
Time Frame: 4 weeks
4 weeks
Change in fasting plasma glucose level from baseline
Time Frame: 16 weeks
16 weeks
Change in fasting plasma glucose level from baseline
Time Frame: 28 weeks
28 weeks
Change in basal insulin dose per body weight (U/kg) from baseline
Time Frame: 24 weeks
24 weeks
Change in total basal insulin dose (U) from baseline
Time Frame: 24 weeks
24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Geropharm

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Olga A Miroshnichenko, PhD, Saint Petersburg State Diagnostic Center № 85

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 20, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 24, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 24, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 5, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 8, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RINPH-IM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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