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

NCT ID: NCT04023344

Last Updated: 2019-07-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 210 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-03-14
• Study Completion Date: 2019-04-18

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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Humalog Mix25

Intervention Type: DRUG

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

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

Group Type: EXPERIMENTAL

Insulin Lispro Biphasic 25

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Geropharm

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Aleksandr Yu Mayorov, MD

Role: PRINCIPAL_INVESTIGATOR

Endocrinology Research Centre

Locations

Chelyabinsk Railway Clinical Hospital

Chelyabinsk, , Russia

Railway Clinical Hospital N.A. Semashko

Moscow, , Russia

Endocrinology Research Centre (Moscow)

Moscow, , Russia

Moscow Endocrinological Dispensary

Moscow, , Russia

Nizhny Novgorod Regional Clinical Hospital

Nizhny Novgorod, , Russia

V.A. Baranov Republic Hospital

Petrozavodsk, , Russia

Rostov State Medical University

Rostov-on-Don, , Russia

City Polyclinic № 77

Saint Petersburg, , Russia

City Hospital № 2

Saint Petersburg, , Russia

City Polyclinic № 117

Saint Petersburg, , Russia

City Polyclinic № 17

Saint Petersburg, , Russia

Institute of Medical Research

Saint Petersburg, , Russia

Research Center Eco-Safety

Saint Petersburg, , Russia

City Hospital №40

Saint Petersburg, , Russia

Pokrovskaya Municipal Hospital

Saint Petersburg, , Russia

Diabetes Center

Samara, , Russia

Clinical City Hospital № 9

Saratov, , Russia

Siberian State Medical University

Tomsk, , Russia

Countries

Russia

References

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.

Reference Type: DERIVED

PMID: 33355484 (View on PubMed)

Other Identifiers

LISPRO25-IM

Identifier Type: -

Identifier Source: org_study_id