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
Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients
Sponsors
Source
Geropharm
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Completed
Start Date
2018-03-14
Completion Date
2019-04-18
Primary Completion Date
2019-01-15
Phase
Phase 3
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Antibody Response |
26 weeks |
Secondary Outcome
Measure |
Time Frame |
|
Adverse Events frequency and degree |
26 weeks (4+22 weeks) |
|
HbA1c |
26 weeks |
|
Fasting Plasma Glucose Level |
26 weeks |
|
Seven-Point Glucose Testing |
26 weeks |
|
Insulin Dose |
26 weeks |
|
Body Mass Index |
26 weeks |
|
Treatment Satisfaction |
26 weeks |
Enrollment
210
Conditions
Intervention
Intervention Type
Drug
Intervention Name
Description
Subcutaneus injections Humalog® Mix 25 twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Arm Group Label
Humalog® Mix 25
Intervention Type
Drug
Intervention Name
Description
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
Arm Group Label
Insulin Lispro Biphasic 25
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
Gender
All
Minimum Age
18 Years
Maximum Age
65 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Aleksandr Yu Mayorov, MD |
Principal Investigator |
Endocrinology Research Centre |
Location
Facility |
|
Chelyabinsk Railway Clinical Hospital Chelyabinsk 454000 Russian Federation |
|
Railway Clinical Hospital N.A. Semashko Moscow 109386 Russian Federation |
|
Endocrinology Research Centre (Moscow) Moscow 117036 Russian Federation |
|
Moscow Endocrinological Dispensary Moscow 119034 Russian Federation |
|
Nizhny Novgorod Regional Clinical Hospital Nizhny Novgorod 603126 Russian Federation |
|
V.A. Baranov Republic Hospital Petrozavodsk 185000 Russian Federation |
|
Rostov State Medical University Rostov-on-Don 344022 Russian Federation |
|
City Polyclinic № 77 Saint Petersburg 192177 Russian Federation |
|
City Hospital № 2 Saint Petersburg 194354 Russian Federation |
|
City Polyclinic № 117 Saint Petersburg 194358 Russian Federation |
|
City Polyclinic № 17 Saint Petersburg 195176 Russian Federation |
|
Institute of Medical Research Saint Petersburg 196084 Russian Federation |
|
Research Center Eco-Safety Saint Petersburg 196143 Russian Federation |
|
City Hospital №40 Saint Petersburg 197706 Russian Federation |
|
Pokrovskaya Municipal Hospital Saint Petersburg 199106 Russian Federation |
|
Diabetes Center Samara 443067 Russian Federation |
|
Clinical City Hospital № 9 Saratov 410030 Russian Federation |
|
Siberian State Medical University Tomsk 634050 Russian Federation |
Location Countries
Country
Russian Federation
Verification Date
2019-01-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Intervention Browse
Mesh Term
Insulin
Insulin, Globin Zinc
Insulin Lispro
Insulin, Isophane
Biphasic Insulins
Arm Group
Arm Group Label
Humalog® Mix 25
Arm Group Type
Active Comparator
Description
Insulin Humalog® Mix 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
Arm Group Label
Insulin Lispro Biphasic 25
Arm Group Type
Experimental
Description
Insulin Lispro Biphasic 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
Firstreceived Results Date
N/A
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)
Study First Submitted
July 5, 2019
Study First Submitted Qc
July 16, 2019
Study First Posted
July 17, 2019
Last Update Submitted
July 16, 2019
Last Update Submitted Qc
July 16, 2019
Last Update Posted
July 17, 2019
ClinicalTrials.gov processed this data on July 17, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.