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

Sponsor
Geropharm (Industry)
Overall Status
Completed
CT.gov ID
NCT04023344
Collaborator
(none)
210
Enrollment
18
Locations
2
Arms
13.1
Actual Duration (Months)
11.7
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Humalog Mix25
  • Drug: Insulin Lispro Biphasic 25
 Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
210 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Mar 14, 2018
Actual Primary Completion Date :
Jan 15, 2019
Actual Study Completion Date :
Apr 18, 2019

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Humalog® Mix 25

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

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
Experimental: 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

Drug: 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

Outcome Measures

Primary Outcome Measures

  1. Antibody Response [26 weeks]

    Change from baseline in titer of antibodies to human insulin

Secondary Outcome Measures

  1. 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

  2. HbA1c [26 weeks]

    Change in HbA1c from baseline

  3. Fasting Plasma Glucose Level [26 weeks]

    Change in fasting plasma glucose level from baseline

  4. Seven-Point Glucose Testing [26 weeks]

    Change in seven-point glucose testing results from baseline

  5. Insulin Dose [26 weeks]

    Change in total insulin dose per body weight (U/kg) from baseline

  6. Body Mass Index [26 weeks]

    Change in BMI from baseline

  7. Treatment Satisfaction [26 weeks]

    Change in overall treatment satisfaction (DTSQ score) from baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Chelyabinsk Railway Clinical Hospital Chelyabinsk Russian Federation 454000
2 Railway Clinical Hospital N.A. Semashko Moscow Russian Federation 109386
3 Endocrinology Research Centre (Moscow) Moscow Russian Federation 117036
4 Moscow Endocrinological Dispensary Moscow Russian Federation 119034
5 Nizhny Novgorod Regional Clinical Hospital Nizhny Novgorod Russian Federation 603126
6 V.A. Baranov Republic Hospital Petrozavodsk Russian Federation 185000
7 Rostov State Medical University Rostov-on-Don Russian Federation 344022
8 City Polyclinic № 77 Saint Petersburg Russian Federation 192177
9 City Hospital № 2 Saint Petersburg Russian Federation 194354
10 City Polyclinic № 117 Saint Petersburg Russian Federation 194358
11 City Polyclinic № 17 Saint Petersburg Russian Federation 195176
12 Institute of Medical Research Saint Petersburg Russian Federation 196084
13 Research Center Eco-Safety Saint Petersburg Russian Federation 196143
14 City Hospital №40 Saint Petersburg Russian Federation 197706
15 Pokrovskaya Municipal Hospital Saint Petersburg Russian Federation 199106
16 Diabetes Center Samara Russian Federation 443067
17 Clinical City Hospital № 9 Saratov Russian Federation 410030
18 Siberian State Medical University Tomsk Russian Federation 634050

Sponsors and Collaborators

  • Geropharm

Investigators

  • Principal Investigator: Aleksandr Yu Mayorov, MD, Endocrinology Research Centre

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Geropharm
ClinicalTrials.gov Identifier:
NCT04023344
Other Study ID Numbers:
  • LISPRO25-IM
First Posted:
Jul 17, 2019
Last Update Posted:
Jul 17, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Geropharm
Diabetes Mellitus, Type 2
Lispro Biphasic
Insulin
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Lispro

Study Results

No Results Posted as of Jul 17, 2019