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A Study to Compare Pharmacokinetics and Pharmacodynamics of RinGlar® to Lantus® 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: NCT04101383
Recruitment Status : Completed
First Posted : September 24, 2019
Last Update Posted : September 24, 2019
Sponsor:
Information provided by (Responsible Party):
Geropharm

Brief Summary:
Pharmacokinetics and pharmacodynamics study of 2 formulation of insulin glargine (RinGlar® GEROPHARM vers. Lantus® Sanofi-Aventis)

Condition or disease Intervention/treatment Phase
Clamp Study Drug: RinGlar® Drug: Lantus® Not Applicable

Detailed Description:
A randomized double blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of RinGlar® (LLC "GEROPHARM", Russia) versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients using the euglycemic clamp technique

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: two-way crossover
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: This study was blinded for Sponsor, investigators and analytical laboratory
Primary Purpose: Basic Science
Official Title: A Randomized Double Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of RinGlar® (LLC "GEROPHARM", Russia) Versus Lantus® (Sanofi-Aventis) in Type 1 Diabetes Mellitus Patients Using the Euglycemic Clamp Technique
Actual Study Start Date : October 16, 2017
Actual Primary Completion Date : February 16, 2018
Actual Study Completion Date : February 16, 2018

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Arm Intervention/treatment
Experimental: RinGlar®
Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg
Drug: RinGlar®
Single subcutaneous administration of RinGlar® in dose 0.6 Units/kg
Other Name: insulin glargine

Active Comparator: Lantus®
Single subcutaneous administration of Lantus® in dose 0.6 Units/kg
Drug: Lantus®
Single subcutaneous administration of Lantus® in dose 0.6 Units/kg
Other Name: insulin glargine




Primary Outcome Measures :
  1. AUC GIR(0-t) [ Time Frame: 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose ]
    Pharmacodynamic of insulin glargine by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))

  2. AUC(0-t) [ Time Frame: -60, -30 and 0 hours (pre-dose), as well as at, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300, 330, 360, 420, 480, 540, 600, 660, 720, 780, 840, 900, 960, 1020, 1080, 1140, 1200, 1260, 1320, 1380, 1440 minutes post-dose ]
    Pharmacokinetics of insulin glargine by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))



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

Inclusion Criteria:

  1. Signed informed consent.
  2. Caucasian males having confirmed diabetes mellitus type 1 (WHO criteria) for at least 12 months prior to screening.
  3. Age of 18-65 (both incl.).
  4. HbA1С ≤ 8,0 %.
  5. Insulin therapy in stable doses at least 3 months. Total dose of insulin ≤ 1,2 IU/kg per day.
  6. At least 6 months of Lantus use.
  7. C-peptide ≤ 0,3 nM/L (or 0,5 ng/mL).
  8. Body mass index equal to 18.5-32.0 kg/m2.
  9. Subject must use, with their partner, methods of highly effective contraception throughout the study.
  10. Subject is able and willing to comply with the requirements of the study protocol.

Exclusion Criteria:

  1. Acute inflammatory diseases within 3 weeks before the screening period.
  2. History or presence of uncontrolled diabetes mellitus for 6 months prior to screening.
  3. Clinically significant diabetes mellitus complications (proliferative retinopathy, severe diabetic neuropathy, diabetic nephropathy (CKD-EPI < 60 mL/min/1,73 m2), diabetic foot).
  4. Clinically significant deviations in basic vital signs (blood pressure, heart rate, respiration rate, body temperature), ECG and lab tests.
  5. Deep vein thrombosis of lower extremities in a history of life or in a family history.
  6. Taking medications (excl. insulin and ACE-inhibitors), phytopreparations, biologically active supplements less than 14 days before screening.
  7. Donor blood donation or another blood loss, less than 3 months before the study.
  8. Recovery after surgery process.
  9. Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol, including psychiatric disorders.
  10. History of significant drugs abuse conditions for 3 years prior to screening.
  11. Positive testing for drugs.
  12. Receiving more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of strong alcohol) or anamnestic information about alcoholism.
  13. Positive testing for alcohol.
  14. Nicotine dependence (use of tobacco less than 6 months before the start of screening).
  15. Positive test results for hepatitis C or hepatitis B, HIV, syphilis.
  16. Presence of suspicions of an inflammatory disease of the urinary system as a result of urinalysis.
  17. Weighed allergic anamnesis.
  18. Presence of oncology disease in the anamnesis 5 years prior the start of screening.
  19. Organ transplantation in anamnesis (excl. cornea transplantation at least 3 month prior the IP administration).
  20. Participation in a clinical trial of any medications less than 3 months before the IP administration.
  21. Any other conditions that make it difficult, according to the informed opinion of the investigating physician, that volunteer participation in studies.
  22. History of hypersensitivity to insulin, heparin and excipients of the drugs using in 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): NCT04101383


Locations
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Russian Federation
Endocrinology Research Centre
Moscow, Russian Federation, 117036
Almazov National Medical Research Centre
Saint Petersburg, Russian Federation, 197341
Sponsors and Collaborators
Geropharm
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Responsible Party: Geropharm
ClinicalTrials.gov Identifier: NCT04101383    
Other Study ID Numbers: GLARGIN-CL
First Posted: September 24, 2019    Key Record Dates
Last Update Posted: September 24, 2019
Last Verified: September 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:
Pharmacokinetics
Pharmacodynamics
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
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs