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Comparative Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method

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ClinicalTrials.gov Identifier: NCT04501250
Recruitment Status : Completed
First Posted : August 6, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Geropharm

Tracking Information
First Submitted Date  ICMJE August 3, 2020
First Posted Date  ICMJE August 6, 2020
Last Update Posted Date August 6, 2020
Actual Study Start Date  ICMJE October 23, 2017
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • Смах [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Test Drug Observed Maximum Plasma Concentration (Cmax)
  • AUC 0-12 [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Total area under the curve "drug concentration - time" in the time interval from 0 to 12 h
  • AUC GIR 0-12 [ Time Frame: -2, -1.5, 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour ]
    Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 12 h
  • AUC GIR 0-24 [ Time Frame: -2, -1.5, 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour ]
    Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 24 h
  • GIRmax [ Time Frame: -2, -1.5, 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour ]
    Maximum glucose infusion rate over the study period
  • tGIRmax [ Time Frame: -2, -1.5, 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour ]
    Time to reach maximum glucose infusion rate
  • tGIRlag [ Time Frame: -2, -1.5, 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour ]
    Time between the drug administration and the onset of action
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: August 3, 2020)
  • AUC 0-2 [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Total area under the curve "drug concentration - time" in the time interval from 0 to 2 h
  • AUC 0-6 [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Total area under the curve "drug concentration - time" in the time interval from 0 to 6 h
  • AUC 0-24 [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Total area under the curve "drug concentration - time" in the time interval from 0 to 24 h
  • AUC 0-∞ [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Total area under the curve "drug concentration - time" in the time interval from 0 to ∞
  • Tmax [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Time to reach test drug Maximum Plasma Concentration
  • T1/2 [ Time Frame: - 1 , -0.5 , 0, 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4, 4.5, 5, 5.5, 6, 6.5, 7, 7.5, 8, 9, 10, 11, 12, 13, 14, 15, 16, 18, 20, 22, 24 hours ]
    Half-life of a drug tested
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparative Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method
Official Title  ICMJE A Double-blinded, Randomized, Comparative, Crossover Pharmacokinetics Study of Rinsulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, Suspension for Subcutaneous Administration, 100 IU/ml (Lilly France, France) Using Method of Euglycemic Hyperinsulinemic Clamp on Healthy Volunteers
Brief Summary Сomparative pharmacokinetic study of Rinsulin® NPH, suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France) using the euglycemic hyperinsulinemic clamp.
Detailed Description A double-blinded, randomized, comparative, crossover pharmacokinetics study of Rinsulin® NPH, suspension for subcutaneous administration, 100 IU/ml (GEROPHARM LLC, Russia) and Humulin® NPH, suspension for subcutaneous administration, 100 IU/ml (Lilly France, France) using method of euglycemic hyperinsulinemic clamp on healthy volunteers
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:
Crossover Assignment two-way crossover
Masking: Double (Participant, Investigator)
Masking Description:
A double-blinded
Primary Purpose: Basic Science
Condition  ICMJE
  • Pharmacokinetics
  • Bioequivalence
Intervention  ICMJE
  • Drug: Rinsulin NPH
    subcutaneous injection at a dose of 0.4 IU/kg
  • Drug: Humulin NPH
    subcutaneous injection at a dose of 0.4 IU/kg
Study Arms  ICMJE
  • Experimental: Rinsulin® NPH
    Single subcutaneous administration of Insulin at a dose 0.4 IU / kg
    Interventions:
    • Drug: Rinsulin NPH
    • Drug: Humulin NPH
  • Active Comparator: Humulin® NPH
    Single subcutaneous administration of Insulin at a dose 0.4 IU / kg
    Interventions:
    • Drug: Rinsulin NPH
    • Drug: Humulin NPH
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 3, 2020)
52
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 21, 2018
Actual Primary Completion Date January 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Signed informed consent to participate in the study.
  • Men of the Caucasian race with a verified diagnosis "healthy" according to the data of standard clinical, laboratory and instrumental examination methods.
  • Age 18-50, inclusive.
  • Body mass index 18.5 - 27 kg / m2.
  • Volunteers who have sexual contact with fertile women should agree to use barrier methods of contraception while participating in the study (unless they have undergone surgical sterilization). Study Participants must also not become a sperm donor within the specified period.
  • Consent to all restrictions imposed during the study.

Exclusion Criteria:

  • Acute inflammatory diseases within 3 weeks from the moment of complete recovery to the stage of screening.
  • Presence of episodes of hypoglycemia in the history of the volunteer
  • Presence in the family history of the closest relatives cases of verified diagnosis of diabetes mellitus of any type.
  • Deviations from the norm of basic vital indicators (heart rate, blood pressure, respiratory rate, body temperature) and ECG from normal values and laboratory values from reference values during screening.
  • Fasting plasma glucose> 6.1 mmol / L at screening.
  • HbA1C> 6% at the time of screening.
  • Oral glucose tolerance test - blood glucose level ≥7.8 mmol / L (2 hours after glucose loading) during screening.
  • Hard-to-reach veins of the upper extremities, vein thrombosis, history of thrombophlebitis or family history of close relatives, "compromised" veins due to frequent preceding venipuncture.
  • Taking medications, phytopreparations, biologically active additives within 14 days before screening.
  • Significant blood loss 3 months before screening due to, for example, but not limited to the following points: a. donor blood donation; b. extended surgery or trauma leading to significant blood loss.
  • Incomplete recovery from surgery or surgery scheduled while the volunteer is participating in the study.
  • Mental, physical and other reasons interferes with adequately assessing behavior and correctly fulfill the conditions of the research protocol (incl. a history of mental illness).
  • Presence or history (three years before the the study drug) of narcotic, drug and / or substance abuse.
  • Positive test for the content of narcotic drugs in urine during the screening period.
  • Anamnestic information about alcoholism or taking more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of dry wine or 50 ml of spirits).
  • Positive test for alcohol in breath during screening.
  • Nicotine addiction (regular use of tobacco less than 6 months before screening).
  • Any chronic diseases, incl. but not limited to positive test results for hepatitis C or hepatitis B, HIV, syphilis at the time of screening.
  • Burdened allergological history.
  • presence of suspicion of an inflammatory disease of the urinary system based on the results of urinalysis during screening.
  • Presence of oncological diseases within 5 years before the screening.
  • History of organ transplantation (except of corneal transplant performed more than 3 months before the first injection of the study drug).
  • Participation in a clinical trial of any drug or experimental medical device within 3 months prior to the first administration of the study drug.
  • Any other condition that, in the reasonable opinion of the research physician, makes it difficult for the volunteer to participate in the study.
  • History of hypersensitivity to heparin, insulin or any of the excipients of the investigational drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Russian Federation
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04501250
Other Study ID Numbers  ICMJE RINCL-NPH
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Geropharm
Study Sponsor  ICMJE Geropharm
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sergei Mr Noskov, AP of medicine Yaroslavl City Clinical Hospital No. 3
PRS Account Geropharm
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP