Status:
COMPLETED
Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients
Lead Sponsor:
Geropharm
Conditions:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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
- 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
- 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
Key Trial Info
Start Date :
March 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 18 2019
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT04023344
Start Date
March 14 2018
End Date
April 18 2019
Last Update
July 17 2019
Active Locations (18)
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1
Chelyabinsk Railway Clinical Hospital
Chelyabinsk, Russia, 454000
2
Railway Clinical Hospital N.A. Semashko
Moscow, Russia, 109386
3
Endocrinology Research Centre (Moscow)
Moscow, Russia, 117036
4
Moscow Endocrinological Dispensary
Moscow, Russia, 119034