AzTrials
AzTrials

Diabetes Mellitus, Type 2Phase 3NCT04226105

Efficacy and Safety of GP40081 Сompared to NovoMix® 30 FlexPen® in Type 2 Diabetes Mellitus Patients

A Phase 3 study testing GP40081 and NovoMix 30 in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Geropharm at 14 sites in Russia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T2DM comparing the efficacy and safety of GP40081 (insulin asapart mix 30, GEROPHARM) with that of NovoMix® 30 FlexPen®. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Diabetes Mellitus, Type 2, Diabetes Mellitus
What is being tested?
GP40081 and NovoMix 30
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
20 Jan 2020to 25 Dec 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 2 for at least 6 months before the screening (WHO criteria 1999-2013).
  • Glycated haemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive).
  • Indications for exogenous insulin therapy.
  • Body mass index (BMI) of 18.5 to 40 kg/m2 at screening (both values inclusive).
  • Insulin-naive patients or prior insulin therapy at least 6 months before randomization.
  • The subject is able and willing to comply with the requirements of the study protocol

Who cannot join

  • Contraindication to the use of insulin aspart 30 mix.
  • 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 severe hypoglycemia for 6 months before the screening.
  • History of severe hyperglycemia for 6 months before the screening.
  • Bariatric surgery for 12 months to screening.
  • Glucagon-like peptide-1 (GLP-1)-based therapies for 8 weeks to screening.
Show all 28Show fewer
  • Insulin resistance over 1.5 U/kg insulin pro day.
  • Change INN of insulin for 6 months before the randomisation.
  • History of treatment any experimental drugs or medical devices for 3 months before the randomisation.
  • Presence of severe diabetes complications.
  • Night work.
  • History of administration of glucocorticoids (14 days or more) for 1 year before the screening.
  • Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexate, Rituximab, etc.).
  • History of vaccination for 6 months before the randomisation.
  • History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except vetiligo and Hashimoto's thyroiditis.
  • Pregnant and breast-feeding women.
  • Deviation of the laboratory results conducted during the screening: Hemoglobin value < 9,0 g/dl; Hematocrit value < 30 %; ALT and AST value > 2 folds or ALT or AST value > 3 folds as high as maximal normal value; Serum bilirubin value > 2 folds as high as maximal normal value (except Gilbert's syndrome).
  • History of haematological disorders that can affect the reliability of HbA1c estimation (haemoglobinopathies, hemolytic anaemia, etc.).
  • Serological evidence of human immunodeficiency virus (HIV), hepatitis B (HbSAg), hepatitis C (HCVAb) or syphilis (Treponema pallidum) antibodies at the screening.
  • Acute inflammation disease for 3 weeks before the screening.
  • History of unstable angina, myocardial infarction, severe arrhythmia, heart failure III or IV NYHA for 1 year before the screening.
  • History of stroke or TIA for 6 months before the screening.
  • Serious blood loss for 3 months before the screening (blood donation, surgery procedure, etc.).
  • The inability of the patient to assess their condition because of mental or physical disorders.
  • History of drug, alcohol abuse for 3 years before the screening.
  • History of oncology disorders for 5 years before the screening.
  • History of transplantation, except 3 months after a 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

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

  • V.A. Baranov Republic Hospital

    Petrozavodsk, 185000

  • City Diagnostic Center № 1

    Saint Petersburg, 194354

  • City Hospital № 2

    Saint Petersburg, 194354

  • City Polyclinic № 117

    Saint Petersburg, 194358

  • EosMed

    Saint Petersburg, 195197

  • Institute of Medical Research

    Saint Petersburg, 196084

  • Research Center Eco-Safety

    Saint Petersburg, 196143

  • Almazov National Medical Research Centre

    Saint Petersburg, 197341

  • Pokrovskaya Municipal Hospital

    Saint Petersburg, 199106

  • Diabetes Center

    Samara, 443067

  • Volgograd Region Clinical Hospital №1

    Volgograd, 400081

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 GP40081 (OOO "GEROPHARM", Russia) Compared to NovoMix® 30 FlexPen® (Novo Nordisk A/S, Denmark) in Type 2 Diabetes Mellitus Patients

This trial is a multi-center, open-label, randomized, parallel group trial in adult patients with T2DM comparing the efficacy and safety of GP40081 (insulin asapart mix 30, GEROPHARM) with that of NovoMix® 30 FlexPen®.

Being tested
GP40081, NovoMix 30
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

  • GP40081Drug

    Also called Insulin aspart 30 mix

    1 ml of the GP40081 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.

  • NovoMix 30Drug

    Also called Insulin aspart 30 mix

    1 ml of the NovoMix 30 contains 100 units soluble insulin aspart/protamine-crystallised insulin aspart in the ratio 30/70. Insulin aspart 30 mix is self-administered drug by SC injection 1-3 times per day before meal intake.

Study groups in NCT04226105
Study groupRoleWhat they receive
GP40081ExperimentalSubcutaneous (SC), up to Week 26
Receives: Drug: GP40081
NovoMix® 30 FlexPen®Active comparatorSubcutaneous (SC), up to Week 26
Receives: Drug: NovoMix 30

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: 22 weeks

  5. Total Insulin Dose

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

    Measured: 22 weeks

  6. Body Mass Index

    Change in BMI from baseline

    Measured: 26 weeks

  7. Treatment Satisfaction: The Diabetes Treatment Satisfaction Questionnaire

    Change in treatment satisfaction from baseline. 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. DTSQ is The Diabetes Treatment Satisfaction Questionnaire, scored from 0-36 points with higher scores indicating better satisfaction.

    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 posted13 Jan 2020
  2. Study start20 Jan 2020
  3. Primary completion30 Sep 2020 (estimated)
  4. Study completion25 Dec 2020 (estimated)

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
Masking
None (open label)
Enrolment
264 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04226105
Sponsor's protocol ID
GP40081-P4-31
Status last verified
Jan 2020
First submitted
9 Jan 2020
Last updated
15 Apr 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing GP40081 and NovoMix 30 in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, 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 7 inclusion and 28 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: status not confirmed, as of the sponsor's last update on 15 Apr 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?

Results are not available in the source record.

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 NCT04226105.

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 15 Apr 2020.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in