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

NCT04079413 | Completed Phase 3

• 1 other identifier: GP40071-P4-31
• Study Type: interventional
• Target: 264
• Locations: 1 country
• Sites: 14

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 aspart, GEROPHARM) with that of NovoRapid®.

Conditions

Diabetes; Diabetes Mellitus, Type 1

Keywords

Insulin; Insulin aspart; Aspart

Outcome Measures

Primary Outcomes (1)

• Immunogenicity

  Change from baseline in titer of antibodies to human insulin

  26 weeks

Secondary Outcomes (9)

• Glycated hemoglobin

  26 weeks

• Adverse Events frequency and degree

  26 weeks

• Fasting Plasma Glucose Level

  26 weeks

• Seven-Point Glucose Testing

  26 weeks

• Total Insulin Dose

  26 weeks

Study Arms (2)

GP40071

EXPERIMENTAL

Subcutaneous (SC), before meals intake, up to Week 26

Drug: GP40071

NovoRapid® Penfill®

ACTIVE COMPARATOR

Subcutaneous (SC), before meals intake, up to Week 26

Drug: NovoRapid® Penfill®

Interventions

GP40071 DRUG

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.

Also known as: Insulin aspart

GP40071

NovoRapid® Penfill® DRUG

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.

Also known as: Insulin aspart

NovoRapid® Penfill®

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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 immunosuppressive drugs (Cyclosporine, Methotrexate, 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

Sponsors & Collaborators

• Geropharm: lead

Study Sites (14)

Arkhangelsk Regional Clinical Hospital

Arkhangelsk, 163045, Russia

Location

Kazan Endocrinology Dispensary

Kazan', 420073, Russia

Location

Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky

Krasnoyarsk, 660022, Russia

Location

Endocrinology Research Centre (Moscow)

Moscow, 117036, Russia

Location

Rostov State Medical University

Rostov-on-Don, 344022, Russia

Location

Polyclinic Сomplex

Saint Petersburg, 190013, Russia

Location

City Diagnostic Center № 1

Saint Petersburg, 194354, Russia

Location

City Polyclinic № 117

Saint Petersburg, 194358, Russia

Location

EosMed

Saint Petersburg, 195197, Russia

Location

Institute of Medical Research

Saint Petersburg, 196084, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

Pokrovskaya Municipal Hospital

Saint Petersburg, 199106, Russia

Location

Diabetes Center

Samara, 443067, Russia

Location

Clinical City Hospital № 9

Saratov, 410030, Russia

Location

Related Publications (1)

• Karonova TL, Mayorov AY, Magruk MA, Zyangirova ST, Grigoryeva IV, Khmelnitski OK, Myshkovets A, Parfenova TM, Mosikian AA, Drai RV. Safety and efficacy of GP40071 compared with originator insulin aspart (NovoRapid(R) Penfill(R)) in Type 1 diabetes mellitus. J Comp Eff Res. 2021 Jun;10(9):763-775. doi: 10.2217/cer-2020-0208. Epub 2021 Apr 30.

  PMID: 33928797 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 1; Insulin Resistance

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: June 3, 2019
• Primary Completion: January 21, 2020
• Study Completion: January 21, 2020
• Last Updated: July 23, 2020

Record last verified: 2019-09

Locations

RU (14)