- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06050343
Comparative Study of Rinsulin R (GEROPHARM) and Humulin Regular (Eli Lilly) Euglycemic Hyperinsulinemic Clamp Method
September 15, 2023 updated by: Geropharm
Comparative Study of the Pharmacokinetics and Pharmacodynamics of Rinsulin® R, Solution for Injection, 100 IU/ml (GEROPHARM LLC) and Humulin® Regular, Solution for Injection, 100 IU/ml (Eli Lilly) in Euglycemic Hyperinsulinemic Clamp Method
Pharmacokinetics and pharmacodynamics of Rinsulin® R, injection solution, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, injection solution, 100 IU / ml (Lilly France ", France) using the euglycemic hyperinsulinemic clamp method.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
A double-blind, randomized, comparative, crossover study of the pharmacokinetics and pharmacodynamics of Rinsulin® R, solution for injection, 100 IU / ml (GEROPHARM LLC, Russia) and Humulin® Regular, solution for injection, 100 IU / ml (Lilly France, France) using euglycemic hyperinsulinemic clamp method on healthy volunteers
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Moscow, Russian Federation, 117036
- "National Medical Research Center of Endocrinology" of the Ministry of Health of the Russian Federation
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rinsulin® R
Single subcutaneous administration of Insulin at a dose 0.3 IU / kg
|
subcutaneous injection at a dose of 0.3 IU / kg
Other Names:
subcutaneous injection at a dose of 0.3 IU / kg
Other Names:
|
Active Comparator: Humulin® Regular
Single subcutaneous administration of Insulin at a dose 0.3 IU / kg
|
subcutaneous injection at a dose of 0.3 IU / kg
Other Names:
subcutaneous injection at a dose of 0.3 IU / kg
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Смах
Time Frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Drug Observed Maximum Plasma Concentration
|
-60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
AUC 0-10
Time Frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 10 h
|
-60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
AUC GIR 0-12
Time Frame: - 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 12 h
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- 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
GIRmax
Time Frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Time to reach maximum glucose infusion rate
|
-120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
tGIRmax
Time Frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Time to reach maximum glucose infusion rate
|
-120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
AUC 0-2
Time Frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 2 h
|
-60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
AUC 0-4
Time Frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 4 h
|
-60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
AUC 0-6
Time Frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 6 h
|
-60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Tmax
Time Frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Time to reach test drug Maximum Plasma Concentration
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-60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
T1/2
Time Frame: -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
Half-life of a test drug
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-60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours
|
tGIRlag
Time Frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Time between the drug administration and the onset of action
|
-120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
AUC GIR 0-2
Time Frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 2 h
|
-120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
AUC GIR 0-4
Time Frame: - 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 4 h
|
- 120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
AUC GIR 0-6
Time Frame: -120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 6 h
|
-120 minutes, -90 minutes, -60 minutes, -30 minutes, 0, every 5 minutes till 8 hours, then every 10 minutes till 10 hours and then every 30 minutes till 12 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 19, 2018
Primary Completion (Actual)
May 4, 2018
Study Completion (Actual)
May 4, 2018
Study Registration Dates
First Submitted
August 3, 2020
First Submitted That Met QC Criteria
September 15, 2023
First Posted (Actual)
September 22, 2023
Study Record Updates
Last Update Posted (Actual)
September 22, 2023
Last Update Submitted That Met QC Criteria
September 15, 2023
Last Verified
September 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RINCL-R
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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