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Diabetes Mellitus, Type 1Phase 3NCT04022993

Efficacy and Safety of Insulin RinGlar® Compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients

A Phase 3 study testing Lantus Solostar, 100 Units/mL Subcutaneous Solution and Insulin RinGlar, 100 Units/mL Subcutaneous Solution in people with Diabetes Mellitus, Type 1 and Diabetes Mellitus, 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

The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 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 1, Diabetes Mellitus
What is being tested?
Lantus Solostar, 100 Units/mL Subcutaneous Solution and Insulin RinGlar, 100 Units/mL Subcutaneous Solution
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
14 sitesRussia
Study dates
4 Jul 2018to 15 May 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
  • 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 6.5 to 12.0 % at screening (both values inclusive)
  • Body mass index (BMI) of 18.0 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 glargine
  • Insulin resistance over 1.5 U/kg insulin pro day
  • History of treatment any biosimilar insulin
  • History of treatment any experimental drugs or medical devices for 3 months prior to screening
  • History of treatment insulin pump for 90 days prior to signed written consent or indication for use insulin pump
  • Presence of severe diabetes complications
Show all 29Show fewer
  • History of severe hypoglycemia during 6 months prior to signed written consent
  • History of 15 or more episodes mild hypoglycemia during 1 month prior to signed written consent
  • History or presence of uncontrolled diabetes mellitus for 6 months prior to screening
  • History of administration of glucocorticoids for 1 year prior to screening
  • Administration of any immunosupressive drugs (Cyclosporinum, Methotrexatum, etc.)
  • History of autoimmune disease, except vitiligo and controlled autoimmune polyglandular syndrome (APS) types 1-3, except adrenal insufficiency
  • 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 allergic 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 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 drug, alcohol abuse for 3 years prior to screening
  • Inability follow to protocol
  • History of oncological disease during 5 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 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

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

  • V.A. Baranov Republic Hospital

    Petrozavodsk, 185000

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Polyclinic Сomplex

    Saint Petersburg, 190013

  • City Diagnostic Center № 1

    Saint Petersburg, 194354

  • City Hospital № 2

    Saint Petersburg, 194354

  • City Polyclinic № 117

    Saint Petersburg, 194358

  • EosMed

    Saint Petersburg, 195197

  • Almazov National Medical Research Centre

    Saint Petersburg, 197341

  • Pokrovskaya Municipal Hospital

    Saint Petersburg, 199106

  • 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 Insulin RinGlar® ("Geropharm", Russia) Compared to Lantus® SoloStar® ("Sanofi-Aventis Deutschland GmbH", Germany) in Type 1 Diabetes Mellitus Patients

The study is designed to approve non-inferior efficacy and safety of Insulin RinGlar® compared to Lantus® SoloStar® in Type 1 Diabetes Mellitus Patients.

Being tested
Lantus Solostar, 100 Units/mL Subcutaneous Solution, Insulin RinGlar, 100 Units/mL Subcutaneous Solution
Keywords
Diabetes Mellitus, Type 1, Insulin, Glargine
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin Resistance

What participants receive

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

  • Lantus Solostar, 100 Units/mL Subcutaneous SolutionDrug

    4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

  • Insulin RinGlar, 100 Units/mL Subcutaneous SolutionDrug

    4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

Study groups in NCT04022993
Study groupRoleWhat they receive
Lantus® SoloStar®Active comparatorLantus® SoloStar® once a day, individually glucose-level based administered in stable doses, started before enrollement
Receives: Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution
Insulin RinGlar®ExperimentalInsulin RinGlar® once a day, individually glucose-level based administered in stable doses, started before enrollement
Receives: Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution

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 (10)

  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. Glycated hemoglobin

    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. Basal Insulin Dose

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

    Measured: 26 weeks

  6. Total Insulin Dose

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

    Measured: 26 weeks

  7. Body Mass Index

    Change in BMI from baseline

    Measured: 26 weeks

  8. Treatment Satisfaction

    Change in overall treatment satisfaction (DTSQ score) from baseline

    Measured: 26 weeks

  9. Achievement of Glycated Hemoglobin Goals

    The frequency of achievement glycated hemoglobin goals

    Measured: 26 weeks

  10. 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 posted17 Jul 2019
  2. Study start4 Jul 2018
  3. Primary completion25 Feb 2019
  4. Study completion15 May 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
180 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04022993
Sponsor's protocol ID
GLARGIN-IM
Status last verified
Jan 2019
First submitted
5 Jul 2019
Last updated
17 Jul 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Karonova TL, Mosikian AA, Mayorov AY, Makarenko IE, Zyangirova ST, Afonkina OA, Belikova TM, Zalevskaya AG, Khokhlov AL, Drai RV. Safety and efficacy of GP40061 compared with originator insulin glargine (Lantus(R)): a randomized open-label clinical trial. J Comp Eff Res. 2020 Mar;9(4):263-273. doi: 10.2217/cer-2019-0136. Epub 2020 Feb 6.

    PubMed 32027167

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lantus Solostar, 100 Units/mL Subcutaneous Solution and Insulin RinGlar, 100 Units/mL Subcutaneous Solution in people with Diabetes Mellitus, Type 1 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 6 inclusion and 29 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 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?

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 NCT04022993, 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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