NCT04022993

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
180

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jul 2018

Shorter than P25 for phase_3

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 4, 2018

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 5, 2019

Completed
12 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
Last Updated

July 17, 2019

Status Verified

January 1, 2019

Enrollment Period

8 months

First QC Date

July 5, 2019

Last Update Submit

July 16, 2019

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Keywords

Diabetes Mellitus, Type 1InsulinGlargine

Outcome Measures

Primary Outcomes (1)

  • Antibody Response

    Change from baseline in titer of antibodies to human insulin

    26 weeks

Secondary Outcomes (10)

  • Adverse Events frequency and degree

    26 weeks (4+22 weeks)

  • Glycated hemoglobin

    26 weeks

  • Fasting Plasma Glucose Level

    26 weeks

  • Seven-Point Glucose Testing

    26 weeks

  • Basal Insulin Dose

    26 weeks

  • +5 more secondary outcomes

Study Arms (2)

Lantus® SoloStar®

ACTIVE COMPARATOR

Lantus® SoloStar® once a day, individually glucose-level based administered in stable doses, started before enrollement

Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution

Insulin RinGlar®

EXPERIMENTAL

Insulin RinGlar® once a day, individually glucose-level based administered in stable doses, started before enrollement

Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution

Interventions

Lantus Solostar, 100 Units/mL Subcutaneous SolutionDRUG

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

Lantus® SoloStar®
Insulin RinGlar, 100 Units/mL Subcutaneous SolutionDRUG

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

Insulin RinGlar®

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 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

You may not qualify if:

  • 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
  • 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
  • +14 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

V.A. Baranov Republic Hospital

Petrozavodsk, 185000, 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 Hospital № 2

Saint Petersburg, 194354, Russia

Location

City Polyclinic № 117

Saint Petersburg, 194358, Russia

Location

EosMed

Saint Petersburg, 195197, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

Pokrovskaya Municipal Hospital

Saint Petersburg, 199106, Russia

Location

Clinical City Hospital № 9

Saratov, 410030, Russia

Location

Related Publications (1)

  • 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.

    PMID: 32027167DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes MellitusInsulin Resistance

Interventions

Insulin Glargine

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesHyperinsulinism

Intervention Hierarchy (Ancestors)

Insulin, Long-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Tatyana L Karonova, MD, DSc

    Almazov National Medical Research Centre

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 5, 2019

First Posted

July 17, 2019

Study Start

July 4, 2018

Primary Completion

February 25, 2019

Study Completion

May 15, 2019

Last Updated

July 17, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

RU(14)