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Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients

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ClinicalTrials.gov Identifier: NCT04079413
Recruitment Status : Active, not recruiting
First Posted : September 5, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Geropharm

Tracking Information
First Submitted Date  ICMJE September 3, 2019
First Posted Date  ICMJE September 5, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE June 3, 2019
Estimated Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
Immunogenicity [ Time Frame: 26 weeks ]
Change from baseline in titer of antibodies to human insulin
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04079413 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2019)
  • Glycated hemoglobin [ Time Frame: 26 weeks ]
    Change in HbA1c from baseline
  • Adverse Events frequency and degree [ Time Frame: 26 weeks ]
    Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions
  • Fasting Plasma Glucose Level [ Time Frame: 26 weeks ]
    Change in fasting plasma glucose level from baseline
  • Seven-Point Glucose Testing [ Time Frame: 26 weeks ]
    Change in seven-point glucose testing results from baseline
  • Total Insulin Dose [ Time Frame: 26 weeks ]
    Change in total insulin dose per body weight (U/kg) from baseline
  • Body Mass Index [ Time Frame: 26 weeks ]
    Change in BMI from baseline
  • Treatment Satisfaction [ Time Frame: 26 weeks ]
    Change in treatment satisfaction from baseline. The total score DTSQ (The Diabetes Treatment Satisfaction Questionnaire) (range 0-36). Questions 1, 4, 5, 6, 7 and 8 assesses treatment satisfaction (summed these 6 questions). Questions 2 and 3 assess the burden from hyper- and hypoglycemia.
  • Achievement of Glycated Hemoglobin Goals [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin goals
  • Achievement of Glycated Hemoglobin < 7% [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin < 7% ( 7% inclusive)
Original Secondary Outcome Measures  ICMJE
 (submitted: September 3, 2019)
  • Glycated hemoglobin [ Time Frame: 26 weeks ]
    Change in HbA1c from baseline
  • Adverse Events frequency and degree [ Time Frame: 26 weeks ]
    Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions
  • Fasting Plasma Glucose Level [ Time Frame: 26 weeks ]
    Change in fasting plasma glucose level from baseline
  • Seven-Point Glucose Testing [ Time Frame: 26 weeks ]
    Change in seven-point glucose testing results from baseline
  • Total Insulin Dose [ Time Frame: 26 weeks ]
    Change in total insulin dose per body weight (U/kg) from baseline
  • Body Mass Index [ Time Frame: 26 weeks ]
    Change in BMI from baseline
  • Treatment Satisfaction [ Time Frame: 26 weeks ]
    Change in overall treatment satisfaction (DTSQ score) from baseline
  • Achievement of Glycated Hemoglobin Goals [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin goals
  • Achievement of Glycated Hemoglobin < 7% [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin < 7% ( 7% inclusive)
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 GP40071 Compared to NovoRapid® Penfill® in Type 1 Diabetes Mellitus Patients
Official Title  ICMJE An Open-label, Randomized, Multi-center, Parallel-group Clinical Trial Comparing the Efficacy and Safety of GP40071 (OOO "GEROPHARM", Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients
Brief Summary This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T1DM comparing the efficacy and safety of GP40071 (insulin asapart, GEROPHARM) with that of NovoRapid®.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Diabetes
  • Diabetes Mellitus, Type 1
Intervention  ICMJE
  • Drug: GP40071
    GP40071, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
    Other Name: Insulin aspart
  • Drug: NovoRapid® Penfill®
    NovoRapid® Penfill®, 100 per milliliters (U/mL) (dose range of 1 unit to 80 units) self-administered by SC injection, immediately (within 5-10 minutes) before meal intake.
    Other Name: Insulin aspart
Study Arms  ICMJE
  • Experimental: GP40071
    Subcutaneous (SC), before meals intake, up to Week 26
    Intervention: Drug: GP40071
  • Active Comparator: NovoRapid® Penfill®
    Subcutaneous (SC), before meals intake, up to Week 26
    Intervention: Drug: NovoRapid® Penfill®
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 3, 2019)
264
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 23, 2020
Estimated Primary Completion Date January 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed written consent
  • Diabetes mellitus type 1 for at least 12 months prior to screening
  • History of basis-bolus (multiple dose injection (MDI)) therapy in stable doses at least 30 days
  • Glycated hemoglobin (HbA1c) level of 7.1 to 12.0 % at screening (both values inclusive)
  • Body mass index (BMI) of 18.5 to 35 kg/m2 at screening (both values inclusive)
  • Subject is able and willing to comply with the requirements of the study protocol

Exclusion Criteria:

  • Contraindication to the use of insulin aspart
  • Insulin resistance over 1.5 U/kg insulin pro day
  • Change INN of insulin for 6 months prior to randomisation
  • History of treatment any biosimilar insulin for 6 months prior to randomisation (excl. GEROPHARM's insulins)
  • History of treatment any experimental drugs or medical devices for 3 months prior to randomisation
  • History of treatment insulin pump for 180 days prior to signed written consent or indication for use insulin pump
  • Presence of severe diabetes complications
  • History of severe hypoglycemia for 6 months prior to screening
  • History of 15 or more episodes mild hypoglycemia for 1 month prior to screening
  • History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
  • History of administration of glucocorticoids (14 days or more) for 1 year prior to screening
  • Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum, Rituximab, etc.)
  • History of vaccination for 6 months prior to randomisation
  • History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency
  • History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year prior to screening
  • History of stroke or TIA for 6 months prior to 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
  • Pregnant and breast-feeding women
  • 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.)
  • Incomplete recovery after surgery procedure
  • History of drug, alcohol abuse for 3 years prior to screening
  • Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at screening
  • History of oncological disease during 5 years prior to screening
  • History of transplantation, except 3 months after corneal transplant
  • History or presence of a medical condition or disease that in the investigator's opinion would embarrass glycemic control and completion of the study
  • Inability follow to protocol
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (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 NCT04079413
Other Study ID Numbers  ICMJE GP40071-P4-31
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Geropharm
Study Sponsor  ICMJE Geropharm
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Geropharm
Verification Date September 2019

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