Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

July 16, 2019 updated by: Geropharm

An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Insulin Lispro Biphasic 25 ("Geropharm", Russia) Humalog® Mix 25 ("Lilly France", France) in Type 2 Diabetes Mellitus Patients

The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.

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.
210

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, 117036
        • Endocrinology Research Centre (Moscow)
      • Moscow, Russian Federation, 119034
        • Moscow Endocrinological Dispensary
      • Moscow, Russian Federation, 109386
        • Railway Clinical Hospital N.A. Semashko
      • Nizhny Novgorod, Russian Federation, 603126
        • Nizhny Novgorod Regional Clinical Hospital
      • Petrozavodsk, Russian Federation, 185000
        • V.A. Baranov Republic Hospital
      • Rostov-on-Don, Russian Federation, 344022
        • Rostov State Medical University
      • Saint Petersburg, Russian Federation, 194354
        • City Hospital № 2
      • Saint Petersburg, Russian Federation, 194358
        • City Polyclinic № 117
      • Saint Petersburg, Russian Federation, 196084
        • Institute of Medical Research
      • Saint Petersburg, Russian Federation, 196143
        • Research Center Eco-Safety
      • Saint Petersburg, Russian Federation, 199106
        • Pokrovskaya Municipal Hospital
      • Saint Petersburg, Russian Federation, 195176
        • City Polyclinic № 17
      • Saint Petersburg, Russian Federation, 192177
        • City Polyclinic № 77
      • Saint Petersburg, Russian Federation, 197706
        • City Hospital №40
      • Samara, Russian Federation, 443067
        • Diabetes Center
      • Saratov, Russian Federation, 410030
        • Clinical City Hospital № 9
      • Tomsk, Russian Federation, 634050
        • Siberian State Medical University

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Signed written consent
  • Clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
  • Glycosylated hemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive)
  • Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive)
  • Stable doses OADs for at least 3 months prior to treatment of experimental drug
  • 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:

  • Acute inflammation disease for 3 weeks prior to screening
  • Deviation of the laboratory results conducted during the screening:

Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds as high as maximal normal value; Serum bilirubin value > 1.5 folds as high as maximal normal value

  • History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.)
  • Serious blood loss for 3 months prior to screening (blood donation, surgery procedure, etc.)
  • Contraindication to the use of insulin Lispro Biphasic 25
  • Insulin resistance over 1.5 U/kg insulin pro day
  • Presence of insulin antibodies in the blood at the screening ˃10 U/ml
  • Use of 3 or more oral antidiabetic drugs (OAD)
  • Presence of severe diabetes complications
  • History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
  • Deviation of vital signs, which can influence to results
  • History of administration of glucocorticoids for 1 year prior to screening
  • History of autoimmune disease, except controlled autoimmune thyroid disease
  • Pregnant and breast-feeding women
  • 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
  • Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexatum)
  • Incomplete recovery after surgery procedure

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: Humalog® Mix 25
Insulin Humalog® Mix 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
Drug: Humalog Mix25
Subcutaneus injections Humalog® Mix 25 twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Experimental: Insulin Lispro Biphasic 25
Insulin Lispro Biphasic 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
Drug: Insulin Lispro Biphasic 25
Subcutaneus injections Insulin Lispro Biphasic 25 ("Geropharm") twice daily during 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: 26 weeks
Change from baseline in titer of antibodies to human insulin
26 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
Measure Description
Time Frame
Fasting Plasma Glucose Level
Time Frame: 26 weeks
Change in fasting plasma glucose level from baseline
26 weeks
Body Mass Index
Time Frame: 26 weeks
Change in BMI from baseline
26 weeks
Seven-Point Glucose Testing
Time Frame: 26 weeks
Change in seven-point glucose testing results from baseline
26 weeks
Treatment Satisfaction
Time Frame: 26 weeks
Change in overall treatment satisfaction (DTSQ score) from baseline
26 weeks
Adverse Events frequency and degree
Time Frame: 26 weeks (4+22 weeks)
Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency Occurrence of local reactions at injection sites Occurrence allergic reactions
26 weeks (4+22 weeks)
HbA1c
Time Frame: 26 weeks
Change in HbA1c from baseline
26 weeks
Insulin Dose
Time Frame: 26 weeks
Change in total insulin dose per body weight (U/kg) from baseline
26 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: Aleksandr Yu Mayorov, MD, Endocrinology Research Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.
March 14, 2018

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.
January 15, 2019

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.
April 18, 2019

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 16, 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 17, 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 17, 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 16, 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.
  • LISPRO25-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

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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