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DiabetesPhase 3NCT04079413

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

A Phase 3 study testing GP40071 and NovoRapid® Penfill® in people with Diabetes and Diabetes Mellitus, Type 1, run by Geropharm at 14 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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®. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes, Diabetes Mellitus, Type 1
What is being tested?
GP40071 and NovoRapid® Penfill®
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
264 participants
Where
14 sitesRussia
Study dates
3 Jun 2019to 21 Jan 2020
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 30Show fewer
  • 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
  • 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

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Russia14 sites

  • Arkhangelsk Regional Clinical Hospital

    Arkhangelsk, 163045

  • Kazan Endocrinology Dispensary

    Kazan', 420073

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

    Krasnoyarsk, 660022

  • Endocrinology Research Centre (Moscow)

    Moscow, 117036

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Polyclinic Сomplex

    Saint Petersburg, 190013

  • City Diagnostic Center № 1

    Saint Petersburg, 194354

  • City Polyclinic № 117

    Saint Petersburg, 194358

  • EosMed

    Saint Petersburg, 195197

  • Institute of Medical Research

    Saint Petersburg, 196084

  • Almazov National Medical Research Centre

    Saint Petersburg, 197341

  • Pokrovskaya Municipal Hospital

    Saint Petersburg, 199106

  • Diabetes Center

    Samara, 443067

  • Clinical City Hospital № 9

    Saratov, 410030

Other trials in Russia

About this study

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

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®.

Being tested
GP40071, NovoRapid® Penfill®
Keywords
Insulin, Insulin aspart, Aspart
Medical subject headings
Diabetes Mellitus, Diabetes Mellitus, Type 1, Insulin Resistance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GP40071Drug

    Also called Insulin aspart

    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.

  • NovoRapid® Penfill®Drug

    Also called Insulin aspart

    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.

Study groups in NCT04079413
Study groupRoleWhat they receive
GP40071ExperimentalSubcutaneous (SC), before meals intake, up to Week 26
Receives: Drug: GP40071
NovoRapid® Penfill®Active comparatorSubcutaneous (SC), before meals intake, up to Week 26
Receives: Drug: NovoRapid® Penfill®

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Immunogenicity

    Change from baseline in titer of antibodies to human insulin

    Measured: 26 weeks

Secondary outcomes (9)

  1. Glycated hemoglobin

    Change in HbA1c from baseline

    Measured: 26 weeks

  2. Adverse Events frequency and degree

    Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions

    Measured: 26 weeks

  3. Fasting Plasma Glucose Level

    Change in fasting plasma glucose level from baseline

    Measured: 26 weeks

  4. Seven-Point Glucose Testing

    Change in seven-point glucose testing results from baseline

    Measured: 26 weeks

  5. Total Insulin Dose

    Change in total insulin dose per body weight (U/kg) from baseline

    Measured: 26 weeks

  6. Body Mass Index

    Change in BMI from baseline

    Measured: 26 weeks

  7. Treatment Satisfaction

    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.

    Measured: 26 weeks

  8. Achievement of Glycated Hemoglobin Goals

    The frequency of achievement glycated hemoglobin goals

    Measured: 26 weeks

  9. Achievement of Glycated Hemoglobin < 7%

    The frequency of achievement glycated hemoglobin < 7% ( 7% inclusive)

    Measured: 26 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Sep 2019
  2. Study start3 Jun 2019
  3. Primary completion21 Jan 2020
  4. Study completion21 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment
Masking
None (open label)
Enrolment
264 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04079413
Sponsor's protocol ID
GP40071-P4-31
Status last verified
Sep 2019
First submitted
3 Sep 2019
Last updated
23 Jul 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33928797

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP40071 and NovoRapid® Penfill® in people with Diabetes and Diabetes Mellitus, Type 1, run by Geropharm at 14 sites in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Immunogenicity (time frame: 26 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04079413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jul 2020.

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