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

Phase 3

Completed

• Conditions: Diabetes Mellitus; Diabetes Mellitus, Type 2
• Interventions: Drug: Humalog Mix25; Drug: Insulin Lispro Biphasic 25

• Registration Number: NCT04023344
• Lead Sponsor: Geropharm

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-03-14
• Status Verified: 2019-01
• Primary Completion: 2019-01-15
• Study Completion: 2019-04-18
• Study First Submitted: 2019-07-05
• Study First Submitted QC: 2019-07-16
• Last Update Submitted: 2019-07-16
• Study First Posted: 2019-07-17
• Last Update Posted: 2019-07-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 210

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Humalog® Mix 25	Humalog Mix25	Insulin Humalog® Mix 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
Insulin Lispro Biphasic 25	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

Primary Outcome Measures

Name	Time	Method
Antibody Response	26 weeks	Change from baseline in titer of antibodies to human insulin

Secondary Outcome Measures

Name	Time	Method
Treatment Satisfaction	26 weeks	Change in overall treatment satisfaction (DTSQ score) from baseline
Adverse Events frequency and degree	26 weeks (4+22 weeks)	Hypoglycemic episodes (glucose level \< 3.9 mmol/l) frequency Occurrence of local reactions at injection sites Occurrence allergic reactions
Fasting Plasma Glucose Level	26 weeks	Change in fasting plasma glucose level from baseline
Seven-Point Glucose Testing	26 weeks	Change in seven-point glucose testing results from baseline
HbA1c	26 weeks	Change in HbA1c from baseline
Body Mass Index	26 weeks	Change in BMI from baseline
Insulin Dose	26 weeks	Change in total insulin dose per body weight (U/kg) from baseline

Trial Locations

Locations (18)

Siberian State Medical University; 🇷🇺 Tomsk, Russian Federation

Chelyabinsk Railway Clinical Hospital; 🇷🇺 Chelyabinsk, Russian Federation

Railway Clinical Hospital N.A. Semashko; 🇷🇺 Moscow, Russian Federation

Endocrinology Research Centre (Moscow); 🇷🇺 Moscow, Russian Federation

V.A. Baranov Republic Hospital; 🇷🇺 Petrozavodsk, Russian Federation

Moscow Endocrinological Dispensary; 🇷🇺 Moscow, Russian Federation

Nizhny Novgorod Regional Clinical Hospital; 🇷🇺 Nizhny Novgorod, Russian Federation

Rostov State Medical University; 🇷🇺 Rostov-on-Don, Russian Federation

City Polyclinic № 17; 🇷🇺 Saint Petersburg, Russian Federation

City Polyclinic № 77; 🇷🇺 Saint Petersburg, Russian Federation

City Hospital № 2; 🇷🇺 Saint Petersburg, Russian Federation

City Polyclinic № 117; 🇷🇺 Saint Petersburg, Russian Federation

Research Center Eco-Safety; 🇷🇺 Saint Petersburg, Russian Federation

City Hospital №40; 🇷🇺 Saint Petersburg, Russian Federation

Diabetes Center; 🇷🇺 Samara, Russian Federation

Institute of Medical Research; 🇷🇺 Saint Petersburg, Russian Federation

Pokrovskaya Municipal Hospital; 🇷🇺 Saint Petersburg, Russian Federation

Clinical City Hospital № 9; 🇷🇺 Saratov, Russian Federation