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Efficacy and Safety of GP40071 Compared to NovoRapid® Penfill® in Type 1 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: NCT04079413
Recruitment Status : Active, not recruiting
First Posted : September 5, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Geropharm

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®.

Condition or disease Intervention/treatment Phase
Diabetes Diabetes Mellitus, Type 1 Drug: GP40071 Drug: NovoRapid® Penfill® Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 264 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 GP40071 (OOO "GEROPHARM", Russia) Compared to NovoRapid® Penfill® (Novo Nordisk A/S, Denmark) in Type 1 Diabetes Mellitus Patients
Actual Study Start Date : June 3, 2019
Estimated Primary Completion Date : January 24, 2020
Estimated Study Completion Date : April 23, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Experimental: GP40071
Subcutaneous (SC), before meals intake, up to Week 26
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

Active Comparator: NovoRapid® Penfill®
Subcutaneous (SC), before meals intake, up to Week 26
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




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


Secondary Outcome Measures :
  1. Glycated hemoglobin [ Time Frame: 26 weeks ]
    Change in HbA1c from baseline

  2. 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

  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. Total 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 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.

  8. Achievement of Glycated Hemoglobin Goals [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin goals

  9. Achievement of Glycated Hemoglobin < 7% [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin < 7% ( 7% inclusive)



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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
  • 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

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): NCT04079413


Locations
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Russian Federation
Arkhangelsk Regional Clinical Hospital
Arkhangel'sk, Russian Federation, 163045
Kazan Endocrinology Dispensary
Kazan, Russian Federation, 420073
Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky
Krasnoyarsk, Russian Federation, 660022
Endocrinology Research Centre (Moscow)
Moscow, Russian Federation, 117036
Rostov State Medical University
Rostov-on-Don, Russian Federation, 344022
Polyclinic Сomplex
Saint Petersburg, Russian Federation, 190013
City Diagnostic Center № 1
Saint Petersburg, Russian Federation, 194354
City Polyclinic № 117
Saint Petersburg, Russian Federation, 194358
EosMed
Saint Petersburg, Russian Federation, 195197
Institute of Medical Research
Saint Petersburg, Russian Federation, 196084
Almazov National Medical Research Centre
Saint Petersburg, Russian Federation, 197341
Pokrovskaya Municipal Hospital
Saint Petersburg, Russian Federation, 199106
Diabetes Center
Samara, Russian Federation, 443067
Clinical City Hospital № 9
Saratov, Russian Federation, 410030
Sponsors and Collaborators
Geropharm

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Responsible Party: Geropharm
ClinicalTrials.gov Identifier: NCT04079413     History of Changes
Other Study ID Numbers: GP40071-P4-31
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 9, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
Insulin
Insulin aspart
Aspart
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin, Long-Acting
Insulin degludec, insulin aspart drug combination
Hypoglycemic Agents
Physiological Effects of Drugs