- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04498884
Comparative Study of the Pharmacokinetics of Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France) Using the Euglycemic Hyperinsulinemic Clamp Method
July 30, 2020 updated by: Geropharm
Double-blinded, Randomized, Comparative, Crossover Study of the Pharmacokinetics of Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France) Using the Method of Euglycemic Hyperinsulinemic Clamp on Healthy Volunteers
Pharmacokinetics and pharmacodynamics study of 2 formulations of insulin mixtures Rinsulin® Mix 30/70, Suspension for Subcutaneous Administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) versus Humulin® M3, Suspension for Subcutaneous Administration, 100 IU / ml (Lilly France, France).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Double-blinded, randomized, comparative, crossover study of comparative pharmacokinetics of Rinsulin® mix 30/70, suspension for subcutaneous administration, 100 IU / ml (OJSC GEROPHARM-Bio, Russia) and Humulin® M3, suspension for subcutaneous administration, 100 IU / ml (Lilly France, France) using hyperinsulinemic euglycemic clamp method on healthy volunteers.
Study Type
Interventional
Enrollment (Actual)
32
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
-
Saint-Petersburg, Russian Federation, 194156
- National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation
-
St. Petersburg, Russian Federation, 197342
- LLC "BioEk", 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
16 years to 48 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
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 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;
- Current or history (three years before the first administration of the study drug) of narcotic, drug and / or substance abuse. A positive test for the content of drugs in urine during the screening period;
- Anamnestic information about alcoholism or intake of 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). A positive test for alcohol in breath during the screening period;
- 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® mix 30/70
Single subcutaneous administration of Insulin at a dose 0.4 IU / kg
|
one subcutaneous injection at a dose of 0.4 IU/kg
one subcutaneous injection at a dose of 0.4 IU/kg
|
Active Comparator: Humulin® M3
Single subcutaneous administration of Insulin at a dose 0.4 IU / kg
|
one subcutaneous injection at a dose of 0.4 IU/kg
one subcutaneous injection at a dose of 0.4 IU/kg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC 0-12
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 12 h
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Cmax
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Test Drug Observed Maximum Plasma Concentration
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
GIR 0-12
Time Frame: 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
|
1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
|
GIR 0-24
Time Frame: 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
|
1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
|
GIR max
Time Frame: 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
|
1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
|
tGIRmax
Time Frame: 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
|
1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
|
TGIRlag
Time Frame: 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
|
1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
AUC 0-2
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 2 h
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
AUC 0-24
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 24 h
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
AUC 0-6
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Total area under the curve "drug concentration - time" in the time interval from 0 to 6 h
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
AUC 0-∞
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Total area under the curve "drug concentration - time" in the time interval from 0 h to ∞
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
mean residence time
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
average residence time of a drug molecule in the body
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
kel
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
constant for drug elimination rate
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Tmax
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Time to reach test drug Maximum Plasma Concentration
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
t1/2
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
Half-life of a drug tested
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
t50%-early
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
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reaching 50% of the maximum insulin concentration before reaching Cmax
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-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
t50%-late
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
reaching 50% of the maximum insulin concentration after reaching Cmax
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
ratio Сmax/AUC0-t
Time Frame: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
relative absorption rate
|
-0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
|
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)
July 18, 2017
Primary Completion (Actual)
October 24, 2017
Study Completion (Actual)
October 24, 2017
Study Registration Dates
First Submitted
July 30, 2020
First Submitted That Met QC Criteria
July 30, 2020
First Posted (Actual)
August 5, 2020
Study Record Updates
Last Update Posted (Actual)
August 5, 2020
Last Update Submitted That Met QC Criteria
July 30, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RIN30-70-CL
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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