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Trial record 2 of 2 for:    glargine; rinGlar | Russia

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04022993
Recruitment Status : Completed
First Posted : July 17, 2019
Last Update Posted : July 17, 2019
Sponsor:
Information provided by (Responsible Party):
Geropharm

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Diabetes Mellitus Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 4, 2018
Actual Primary Completion Date : February 25, 2019
Actual Study Completion Date : May 15, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arm Intervention/treatment
Active Comparator: Lantus® SoloStar®
Lantus® SoloStar® once a day, individually glucose-level based administered in stable doses, started before enrollement
Drug: Lantus Solostar, 100 Units/mL Subcutaneous Solution
4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses

Experimental: Insulin RinGlar®
Insulin RinGlar® once a day, individually glucose-level based administered in stable doses, started before enrollement
Drug: Insulin RinGlar, 100 Units/mL Subcutaneous Solution
4 weeks of glucose-level based dose titration, 22 weeks of treatment with stable doses




Primary Outcome Measures :
  1. Antibody Response [ Time Frame: 26 weeks ]
    Change from baseline in titer of antibodies to human insulin


Secondary Outcome Measures :
  1. Adverse Events frequency and degree [ Time Frame: 26 weeks (4+22 weeks) ]
    Hypoglycemic episodes (glucose level < 3.9 mmol/l) frequency; Occurrence of local reactions at injection sites; Occurrence allergic reactions.

  2. Glycated hemoglobin [ Time Frame: 26 weeks ]
    Change in HbA1c from baseline

  3. Fasting Plasma Glucose Level [ Time Frame: 26 weeks ]
    Change in fasting plasma glucose level from baseline

  4. Seven-Point Glucose Testing [ Time Frame: 26 weeks ]
    Change in seven-point glucose testing results from baseline

  5. Basal Insulin Dose [ Time Frame: 26 weeks ]
    Change in basal insulin dose per body weight (U/kg) from baseline

  6. Total Insulin Dose [ Time Frame: 26 weeks ]
    Change in total insulin dose per body weight (U/kg) from baseline

  7. Body Mass Index [ Time Frame: 26 weeks ]
    Change in BMI from baseline

  8. Treatment Satisfaction [ Time Frame: 26 weeks ]
    Change in overall treatment satisfaction (DTSQ score) from baseline

  9. Achievement of Glycated Hemoglobin Goals [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin goals

  10. Achievement of Glycated Hemoglobin < 7% [ Time Frame: 26 weeks ]
    The frequency of achievement glycated hemoglobin < 7% ( 7% inclusive)



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04022993


Locations
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Russian Federation
Arkhangelsk Regional Clinical Hospital
Arkhangel'sk, Russian Federation, 163045
Kazan Endocrinology Dispensary
Kazan, Russian Federation, 420073
Krasnoyarsk State Medical University named after Professor V.F. Voino-Yasenetsky
Krasnoyarsk, Russian Federation, 660022
Endocrinology Research Centre (Moscow)
Moscow, Russian Federation, 117036
V.A. Baranov Republic Hospital
Petrozavodsk, Russian Federation, 185000
Rostov State Medical University
Rostov-on-Don, Russian Federation, 344022
Polyclinic Сomplex
Saint Petersburg, Russian Federation, 190013
City Diagnostic Center № 1
Saint Petersburg, Russian Federation, 194354
City Hospital № 2
Saint Petersburg, Russian Federation, 194354
City Polyclinic № 117
Saint Petersburg, Russian Federation, 194358
EosMed
Saint Petersburg, Russian Federation, 195197
Almazov National Medical Research Centre
Saint Petersburg, Russian Federation, 197341
Pokrovskaya Municipal Hospital
Saint Petersburg, Russian Federation, 199106
Clinical City Hospital № 9
Saratov, Russian Federation, 410030
Sponsors and Collaborators
Geropharm
Investigators
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Principal Investigator: Tatyana L Karonova, MD, DSc Almazov National Medical Research Centre
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Geropharm
ClinicalTrials.gov Identifier: NCT04022993    
Other Study ID Numbers: GLARGIN-IM
First Posted: July 17, 2019    Key Record Dates
Last Update Posted: July 17, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geropharm:
Diabetes Mellitus, Type 1
Insulin
Glargine
Additional relevant MeSH terms:
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Insulin Glargine
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Pharmaceutical Solutions
Hypoglycemic Agents
Physiological Effects of Drugs