NCT04023344

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P25-P50 for phase_3 diabetes-mellitus-type-2

Timeline
Completed

Started Mar 2018

Shorter than P25 for phase_3 diabetes-mellitus-type-2

Geographic Reach
1 country

18 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 14, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 18, 2019

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
Last Updated

July 17, 2019

Status Verified

January 1, 2019

Enrollment Period

10 months

First QC Date

July 5, 2019

Last Update Submit

July 16, 2019

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 2Lispro BiphasicInsulin

Outcome Measures

Primary Outcomes (1)

  • Antibody Response

    Change from baseline in titer of antibodies to human insulin

    26 weeks

Secondary Outcomes (7)

  • Adverse Events frequency and degree

    26 weeks (4+22 weeks)

  • HbA1c

    26 weeks

  • Fasting Plasma Glucose Level

    26 weeks

  • Seven-Point Glucose Testing

    26 weeks

  • Insulin Dose

    26 weeks

  • +2 more secondary outcomes

Study Arms (2)

Humalog® Mix 25

ACTIVE COMPARATOR

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

Insulin Lispro Biphasic 25

EXPERIMENTAL

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

Interventions

Humalog Mix25DRUG

Subcutaneus injections Humalog® Mix 25 twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

Humalog® Mix 25
Insulin Lispro Biphasic 25DRUG

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

Insulin Lispro Biphasic 25

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (18)

Chelyabinsk Railway Clinical Hospital

Chelyabinsk, 454000, Russia

Location

Railway Clinical Hospital N.A. Semashko

Moscow, 109386, Russia

Location

Endocrinology Research Centre (Moscow)

Moscow, 117036, Russia

Location

Moscow Endocrinological Dispensary

Moscow, 119034, Russia

Location

Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, 603126, Russia

Location

V.A. Baranov Republic Hospital

Petrozavodsk, 185000, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

City Polyclinic № 77

Saint Petersburg, 192177, Russia

Location

City Hospital № 2

Saint Petersburg, 194354, Russia

Location

City Polyclinic № 117

Saint Petersburg, 194358, Russia

Location

City Polyclinic № 17

Saint Petersburg, 195176, Russia

Location

Institute of Medical Research

Saint Petersburg, 196084, Russia

Location

Research Center Eco-Safety

Saint Petersburg, 196143, Russia

Location

City Hospital №40

Saint Petersburg, 197706, Russia

Location

Pokrovskaya Municipal Hospital

Saint Petersburg, 199106, Russia

Location

Diabetes Center

Samara, 443067, Russia

Location

Clinical City Hospital № 9

Saratov, 410030, Russia

Location

Siberian State Medical University

Tomsk, 634050, Russia

Location

Related Publications (1)

  • Mayorov AY, Mosikian AA, Alpenidze DN, Makarenko IE, Orlova VL, Lunev IS, Verbovaya MV, Zinnatulina BR, Khokhlov AL, Drai RV. Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients. J Comp Eff Res. 2021 Jan;10(1):55-66. doi: 10.2217/cer-2020-0064. Epub 2020 Dec 23.

    PMID: 33355484DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes MellitusInsulin Resistance

Interventions

insulin lispro, isophane insulin lispro drug combination (25:75)

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperinsulinism

Study Officials

  • Aleksandr Yu Mayorov, MD

    Endocrinology Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 17, 2019

Study Start

March 14, 2018

Primary Completion

January 15, 2019

Study Completion

April 18, 2019

Last Updated

July 17, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(18)