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出境医 / 临床实验 / Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients

Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients

Study Description
Brief Summary:
The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Biological: Insulin Humulin® NPH Biological: Insulin Rinsulin® NPH Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 201 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 Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients
Actual Study Start Date : April 20, 2017
Actual Primary Completion Date : September 24, 2018
Actual Study Completion Date : September 24, 2018
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Insulin Humulin® NPH
Insulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment
 Biological: Insulin Humulin® NPH
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Experimental: Insulin Rinsulin® NPH
Insulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment
 Biological: Insulin Rinsulin® NPH
4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Outcome Measures
Primary Outcome Measures :
  1. Antibody Response [ Time Frame: 24 weeks ]
    Change from baseline in titer of antibodies to human insulin


Secondary Outcome Measures :
  1. Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency [ Time Frame: 28 weeks (4 + 24 weeks) ]
  2. Change in BMI from baseline [ Time Frame: 24 weeks ]
  3. Occurrence of adverse events [ Time Frame: 28 weeks (4 + 24 weeks) ]
  4. Occurrence of Injection Site Reaction [ Time Frame: 28 weeks (4 + 24 weeks) ]
  5. Change in HbA1c from baseline [ Time Frame: 24 weeks ]
  6. Change in fasting plasma glucose level from baseline [ Time Frame: 4 weeks ]
  7. Change in fasting plasma glucose level from baseline [ Time Frame: 16 weeks ]
  8. Change in fasting plasma glucose level from baseline [ Time Frame: 28 weeks ]
  9. Change in basal insulin dose per body weight (U/kg) from baseline [ Time Frame: 24 weeks ]
  10. Change in total basal insulin dose (U) from baseline [ Time Frame: 24 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed written consent
  • Diabetes mellitus type 2
  • Indications for Rinsulin NPH / Humalog NPH treatment
  • Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
  • Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).
  • 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:

  • Age less than 18 years old at screening
  • Pregnant and breast-feeding women
  • Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
  • Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
  • Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening.
  • 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.
  • History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.).
  • History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
  • Presence of severe diabetes complications
  • Receipt of another investigational drug in the 3 months prior to screening
  • Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening
  • History or presence of drug abuse
  • Positive test for addictive substance in urine at screening
Contacts and Locations

Locations
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Russian Federation
Chelyabinsk Railway Clinical Hospital
Chelyabinsk, Russian Federation, 454000
Moscow Endocrinological Dispensary
Moscow, Russian Federation, 119034
Moscow Clinical Hospital № 71
Moscow, Russian Federation, 121374
Nizhny Novgorod Regional Clinical Hospital
Nizhny Novgorod, Russian Federation, 603126
V.A. Baranov Republic Hospital
Petrozavodsk, Russian Federation, 185000
City Polyclinic № 6
Saint Petersburg, Russian Federation, 192148
City Hospital № 2
Saint Petersburg, Russian Federation, 194354
City Polyclinic № 17
Saint Petersburg, Russian Federation, 195176
Medical Sanitary Unit № 157
Saint Petersburg, Russian Federation, 196066
Institute of Medical Research
Saint Petersburg, Russian Federation, 196084
Research Center Eco-Safety
Saint Petersburg, Russian Federation, 196143
Saint Petersburg State Diagnostic Center № 85
Saint Petersburg, Russian Federation, 198260
Diabetes Center
Samara, Russian Federation, 443067
Clinical Hospital № 3
Yaroslavl, Russian Federation, 150007
Sponsors and Collaborators
Geropharm
Investigators
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Principal Investigator: Olga A Miroshnichenko, PhD Saint Petersburg State Diagnostic Center № 85
Tracking Information
First Submitted Date  ICMJE July 5, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE April 20, 2017
Actual Primary Completion Date September 24, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019) 		Antibody Response [ Time Frame: 24 weeks ]
Change from baseline in titer of antibodies to human insulin
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency [ Time Frame: 28 weeks (4 + 24 weeks) ]
  • Change in BMI from baseline [ Time Frame: 24 weeks ]
  • Occurrence of adverse events [ Time Frame: 28 weeks (4 + 24 weeks) ]
  • Occurrence of Injection Site Reaction [ Time Frame: 28 weeks (4 + 24 weeks) ]
  • Change in HbA1c from baseline [ Time Frame: 24 weeks ]
  • Change in fasting plasma glucose level from baseline [ Time Frame: 4 weeks ]
  • Change in fasting plasma glucose level from baseline [ Time Frame: 16 weeks ]
  • Change in fasting plasma glucose level from baseline [ Time Frame: 28 weeks ]
  • Change in basal insulin dose per body weight (U/kg) from baseline [ Time Frame: 24 weeks ]
  • Change in total basal insulin dose (U) from baseline [ Time Frame: 24 weeks ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Insulin Rinsulin® NPH Compared to Humulin® NPH in Type 2 Diabetes Mellitus Patients
Official Title  ICMJE An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of Rinsulin® NPH ("Geropharm", Russia) With Humulin® NPH ("Lilly France", France) in Type 2 Diabetes Mellitus Patients
Brief Summary The study is designed to approve non-inferior efficacy and safety of Rinsulin® NPH compared to Humulin® NPH.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 2
Intervention  ICMJE
  • Biological: Insulin Humulin® NPH
    4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
  • Biological: Insulin Rinsulin® NPH
    4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses
Study Arms  ICMJE
  • Active Comparator: Insulin Humulin® NPH
    Insulin Humulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment
    Intervention: Biological: Insulin Humulin® NPH
  • Experimental: Insulin Rinsulin® NPH
    Insulin Rinsulin® NPH twice daily, individually glucose-level based administered doses +/- 1,2 or 3 OADs in stable doses, started before enrollment
    Intervention: Biological: Insulin Rinsulin® NPH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 8, 2019) 		201
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 24, 2018
Actual Primary Completion Date September 24, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed written consent
  • Diabetes mellitus type 2
  • Indications for Rinsulin NPH / Humalog NPH treatment
  • Glycosylated hemoglobin (HbA1c) level of 6.5 to 12.0 % at screening (both values inclusive)
  • Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive).
  • 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:

  • Age less than 18 years old at screening
  • Pregnant and breast-feeding women
  • Need of administration of glucocorticoid therapy or any other therapy that may influence glucose level
  • Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum)
  • Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or antibodies to Treponema pallidum (syphilis) at screening.
  • 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.
  • History of hematological disorders that can affect the reliability of HbA1c estimation (hemoglobinopathies, hemolytic anemia, etc.).
  • History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
  • Presence of severe diabetes complications
  • Receipt of another investigational drug in the 3 months prior to screening
  • Acute psychiatric disorder or exacerbation of chronic psychiatric disorder at screening
  • History or presence of drug abuse
  • Positive test for addictive substance in urine at screening
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012775
Other Study ID Numbers  ICMJE RINPH-IM
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Geropharm
Study Sponsor  ICMJE Geropharm
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Olga A Miroshnichenko, PhD Saint Petersburg State Diagnostic Center № 85
PRS Account Geropharm
Verification Date January 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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