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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04023344
• Other study ID #: LISPRO25-IM
• Status: Completed
• Phase: Phase 3
• Start date: March 14, 2018
• Est. completion date: April 18, 2019

Study information

• Verified date: January 2019
• Source: Geropharm
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 210
• Est. completion date: April 18, 2019
• Est. primary completion date: January 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

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
• 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

Locations

Country	Name	City	State
Russian Federation	Chelyabinsk Railway Clinical Hospital	Chelyabinsk
Russian Federation	Endocrinology Research Centre (Moscow)	Moscow
Russian Federation	Moscow Endocrinological Dispensary	Moscow
Russian Federation	Railway Clinical Hospital N.A. Semashko	Moscow
Russian Federation	Nizhny Novgorod Regional Clinical Hospital	Nizhny Novgorod
Russian Federation	V.A. Baranov Republic Hospital	Petrozavodsk
Russian Federation	Rostov State Medical University	Rostov-on-Don
Russian Federation	City Hospital ? 2	Saint Petersburg
Russian Federation	City Hospital ?40	Saint Petersburg
Russian Federation	City Polyclinic ? 117	Saint Petersburg
Russian Federation	City Polyclinic ? 17	Saint Petersburg
Russian Federation	City Polyclinic ? 77	Saint Petersburg
Russian Federation	Institute of Medical Research	Saint Petersburg
Russian Federation	Pokrovskaya Municipal Hospital	Saint Petersburg
Russian Federation	Research Center Eco-Safety	Saint Petersburg
Russian Federation	Diabetes Center	Samara
Russian Federation	Clinical City Hospital ? 9	Saratov
Russian Federation	Siberian State Medical University	Tomsk

Sponsors (1)

Lead Sponsor	Collaborator
Geropharm

Country where clinical trial is conducted

Russian Federation, 

Outcome

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