Clinical trial NCT04023344: Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus
Keywords: Diabetes Mellitus, Type 2
Lispro Biphasic
Insulin
Lead sponsor: Geropharm
Sponsor class: INDUSTRY
First posted: 2019-07-17
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Antibody Response
timeFrame: 26 weeks
Secondary outcomes:
measure: Adverse Events frequency and degree
timeFrame: 26 weeks (4+22 weeks)
measure: HbA1c
timeFrame: 26 weeks
measure: Fasting Plasma Glucose Level
timeFrame: 26 weeks
measure: Seven-Point Glucose Testing
timeFrame: 26 weeks
measure: Insulin Dose
timeFrame: 26 weeks
measure: Body Mass Index
timeFrame: 26 weeks
measure: Treatment Satisfaction
timeFrame: 26 weeks
Other outcomes:
Locations:
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Railway Clinical Hospital
city: Moscow
country: Russian Federation
facility: Railway Clinical Hospital N.A. Semashko
city: Moscow
country: Russian Federation
facility: Endocrinology Research Centre (Moscow)
city: Moscow
country: Russian Federation
facility: Moscow Endocrinological Dispensary
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhny Novgorod Regional Clinical Hospital
city: Petrozavodsk
country: Russian Federation
facility: V.A. Baranov Republic Hospital
city: Rostov-on-Don
country: Russian Federation
facility: Rostov State Medical University
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic № 77
city: Saint Petersburg
country: Russian Federation
facility: City Hospital № 2
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic № 117
city: Saint Petersburg
country: Russian Federation
facility: City Polyclinic № 17
city: Saint Petersburg
country: Russian Federation
facility: Institute of Medical Research
city: Saint Petersburg
country: Russian Federation
facility: Research Center Eco-Safety
city: Saint Petersburg
country: Russian Federation
facility: City Hospital №40
city: Saint Petersburg
country: Russian Federation
facility: Pokrovskaya Municipal Hospital
city: Samara
country: Russian Federation
facility: Diabetes Center
city: Saratov
country: Russian Federation
facility: Clinical City Hospital № 9
city: Tomsk
country: Russian Federation
facility: Siberian State Medical University
Study officials:
affiliation: Endocrinology Research Centre
name: Aleksandr Yu Mayorov, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.