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Diabetes Mellitus, Type 2Phase 3NCT04023344

Efficacy and Safety of Insulin Lispro Biphasic 25 Compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients

A Phase 3 study testing Humalog Mix25 and Insulin Lispro Biphasic 25 in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Geropharm at 18 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

The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients. 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?
Humalog Mix25 and Insulin Lispro Biphasic 25
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
210 participants
Where
18 sitesRussia
Study dates
14 Mar 2018to 18 Apr 2019
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
  • Clinical diagnosis of type 2 diabetes mellitus for at least 6 months prior to screening
  • Glycosylated hemoglobin (HbA1c) level of 7.6 to 12.0 % at screening (both values inclusive)
  • Body mass index (BMI) of 18.0 to 35 kg/m2 at screening (both values inclusive)
  • Stable doses OADs for at least 3 months prior to treatment of experimental drug
  • Female patients of childbearing potential who are willing to use two acceptable methods of contraception, (e.g., intra-uterine device plus condom, spermicidal gel plus condom, diaphragm plus condom, etc.), from the time of screening and for the duration of the trial, through trial completion

Who cannot join

  • 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.)
  • Contraindication to the use of insulin Lispro Biphasic 25
Show all 18Show fewer
  • Insulin resistance over 1.5 U/kg insulin pro day
  • Presence of insulin antibodies in the blood at the screening ˃10 U/ml
  • Use of 3 or more oral antidiabetic drugs (OAD)
  • Presence of severe diabetes complications
  • History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
  • Deviation of vital signs, which can influence to results
  • History of administration of glucocorticoids for 1 year prior to screening
  • History of autoimmune disease, except controlled autoimmune thyroid disease
  • Pregnant and breast-feeding women
  • 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
  • Administration of any immunosuppressive drugs (Cyclosporinum, Methotrexatum)
  • Incomplete recovery after surgery procedure

Trial locations and contacts

18 sites in 1 country.

18 sites in 1 country

Russia18 sites

  • Chelyabinsk Railway Clinical Hospital

    Chelyabinsk, 454000

  • Railway Clinical Hospital N.A. Semashko

    Moscow, 109386

  • Endocrinology Research Centre (Moscow)

    Moscow, 117036

  • Moscow Endocrinological Dispensary

    Moscow, 119034

  • Nizhny Novgorod Regional Clinical Hospital

    Nizhny Novgorod, 603126

  • V.A. Baranov Republic Hospital

    Petrozavodsk, 185000

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • City Polyclinic № 77

    Saint Petersburg, 192177

  • City Hospital № 2

    Saint Petersburg, 194354

  • City Polyclinic № 117

    Saint Petersburg, 194358

  • City Polyclinic № 17

    Saint Petersburg, 195176

  • Institute of Medical Research

    Saint Petersburg, 196084

  • Research Center Eco-Safety

    Saint Petersburg, 196143

  • City Hospital №40

    Saint Petersburg, 197706

  • Pokrovskaya Municipal Hospital

    Saint Petersburg, 199106

  • Diabetes Center

    Samara, 443067

  • Clinical City Hospital № 9

    Saratov, 410030

  • Siberian State Medical University

    Tomsk, 634050

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 Insulin Lispro Biphasic 25 ("Geropharm", Russia) Humalog® Mix 25 ("Lilly France", France) in Type 2 Diabetes Mellitus Patients

The study is designed to approve non-inferior efficacy and safety of Insulin Lispro Biphasic 25 ("Geropharm") compared to Humalog® Mix 25 in Type 2 Diabetes Mellitus Patients.

Being tested
Humalog Mix25, Insulin Lispro Biphasic 25
Keywords
Diabetes Mellitus, Type 2, Lispro Biphasic, Insulin
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus, Insulin Resistance

What participants receive

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

  • Humalog Mix25Drug

    Subcutaneus injections Humalog® Mix 25 twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

  • Insulin Lispro Biphasic 25Drug

    Subcutaneus injections Insulin Lispro Biphasic 25 ("Geropharm") twice daily during 4 weeks of glucose-level based dose titration, 24 weeks of treatment with stable doses

Study groups in NCT04023344
Study groupRoleWhat they receive
Humalog® Mix 25Active comparatorInsulin Humalog® Mix 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
Receives: Drug: Humalog Mix25
Insulin Lispro Biphasic 25ExperimentalInsulin Lispro Biphasic 25 twice daily, individually glucose-level based administered doses +/- 1 or 2 OADs in stable doses, started before enrollement
Receives: Drug: Insulin Lispro Biphasic 25

What is being measured

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

  1. Antibody Response

    Change from baseline in titer of antibodies to human insulin

    Measured: 26 weeks

Secondary outcomes (7)

  1. 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 (4+22 weeks)

  2. HbA1c

    Change in HbA1c from baseline

    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. 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 overall treatment satisfaction (DTSQ score) from baseline

    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 posted17 Jul 2019
  2. Study start14 Mar 2018
  3. Primary completion15 Jan 2019
  4. Study completion18 Apr 2019

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
210 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04023344
Sponsor's protocol ID
LISPRO25-IM
Status last verified
Jan 2019
First submitted
5 Jul 2019
Last updated
17 Jul 2019
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Mayorov AY, Mosikian AA, Alpenidze DN, Makarenko IE, Orlova VL, Lunev IS, Verbovaya MV, Zinnatulina BR, Khokhlov AL, Drai RV. Efficacy and safety of GP40021 insulin lispro biphasic compared with Humalog Mix 25 in Type 2 diabetes mellitus patients. J Comp Eff Res. 2021 Jan;10(1):55-66. doi: 10.2217/cer-2020-0064. Epub 2020 Dec 23.

    PubMed 33355484

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Humalog Mix25 and Insulin Lispro Biphasic 25 in people with Diabetes Mellitus, Type 2 and Diabetes Mellitus, run by Geropharm at 18 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 18 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 17 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 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?

Antibody Response (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 NCT04023344, 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 17 Jul 2019.

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