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Trial record 4 of 334 for:    lispro

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04023344
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus Drug: Humalog Mix25 Drug: Insulin Lispro Biphasic 25 Phase 3

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Study Type : Interventional  (Clinical Trial)
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 : March 14, 2018
Actual Primary Completion Date : January 15, 2019
Actual Study Completion Date : April 18, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Antibody Response [ Time Frame: 26 weeks ]
    Change from baseline in titer of antibodies to human insulin


Secondary Outcome Measures :
  1. Adverse Events frequency and degree [ Time Frame: 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 [ Time Frame: 26 weeks ]
    Change in HbA1c from baseline

  3. Fasting Plasma Glucose Level [ Time Frame: 26 weeks ]
    Change in fasting plasma glucose level from baseline

  4. Seven-Point Glucose Testing [ Time Frame: 26 weeks ]
    Change in seven-point glucose testing results from baseline

  5. Insulin Dose [ Time Frame: 26 weeks ]
    Change in total insulin dose per body weight (U/kg) from baseline

  6. Body Mass Index [ Time Frame: 26 weeks ]
    Change in BMI from baseline

  7. Treatment Satisfaction [ Time Frame: 26 weeks ]
    Change in overall treatment satisfaction (DTSQ score) from baseline



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04023344


Locations
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Sponsors and Collaborators
Geropharm
Investigators
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Principal Investigator: Aleksandr Yu Mayorov, MD Endocrinology Research Centre
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Responsible Party: Geropharm
ClinicalTrials.gov Identifier: NCT04023344    
Other Study ID Numbers: LISPRO25-IM
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs