BioequivalenceNCT04498884
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
A study testing Rinsulin® mix 30/70 and Humulin® M3 in people with Bioequivalence, run by Geropharm at 3 sites in Russia.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Bioequivalence
- What is being tested?
- Rinsulin® mix 30/70 and Humulin® M3
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 3 sitesRussia
- Study dates
- 18 Jul 2017to 24 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
3 sites in 1 country.
Russia3 sites
"National Medical Research Center of Endocrinology" of the Ministry of Health of the Russian Federation
Moscow, 117036
National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation
Saint Petersburg, 194156
LLC "BioEk", Russian Federation
Saint Petersburg, 197342
About this study
Official title: 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).
Read the 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.
- Conditions
- Bioequivalence
- Being tested
- Rinsulin® mix 30/70, Humulin® M3
- Keywords
- human recombinant insulin, euglycemic hyperinsulinemic clamp
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rinsulin® mix 30/70Drug
one subcutaneous injection at a dose of 0.4 IU/kg
Humulin® M3Drug
one subcutaneous injection at a dose of 0.4 IU/kg
| Study group | Role | What they receive |
|---|---|---|
| Rinsulin® mix 30/70 | Experimental | Single subcutaneous administration of Insulin at a dose 0.4 IU / kg Receives: Drug: Rinsulin® mix 30/70; Drug: Humulin® M3 |
| Humulin® M3 | Active comparator | Single subcutaneous administration of Insulin at a dose 0.4 IU / kg Receives: Drug: Rinsulin® mix 30/70; Drug: Humulin® M3 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC 0-12
Total area under the curve "drug concentration - time" in the time interval from 0 to 12 h
Measured: -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
Test Drug Observed Maximum Plasma Concentration
Measured: -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
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 12 h
Measured: 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
Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 24 h
Measured: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
GIR max
Maximum glucose infusion rate over the study period
Measured: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
tGIRmax
Time to reach maximum glucose infusion rate
Measured: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
TGIRlag
Time between the drug administration and the onset of action
Measured: 1, -0.5, then every 5 min till 10 hour, every 10 min till 12 hour, every 15 min till 24 hour
Secondary outcomes (11)
AUC 0-2
Total area under the curve "drug concentration - time" in the time interval from 0 to 2 h
Measured: -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
Total area under the curve "drug concentration - time" in the time interval from 0 to 24 h
Measured: -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
Total area under the curve "drug concentration - time" in the time interval from 0 to 6 h
Measured: -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-∞
Total area under the curve "drug concentration - time" in the time interval from 0 h to ∞
Measured: -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
average residence time of a drug molecule in the body
Measured: -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
constant for drug elimination rate
Measured: -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 to reach test drug Maximum Plasma Concentration
Measured: -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
Half-life of a drug tested
Measured: -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
reaching 50% of the maximum insulin concentration before reaching Cmax
Measured: -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
reaching 50% of the maximum insulin concentration after reaching Cmax
Measured: -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
relative absorption rate
Measured: -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2020
- Study start18 Jul 2017
- Primary completion24 Oct 2017
- Study completion24 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BioequivalenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- two-period two-way crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geropharm
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04498884
- Sponsor's protocol ID
- RIN30-70-CL
- Status last verified
- Jul 2020
- First submitted
- 30 Jul 2020
- Last updated
- 5 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04498884
- Acronym / sponsor ID
- RIN30-70-CL
- Conditions
- Bioequivalence
- Keywords
- human recombinant insulin, euglycemic hyperinsulinemic clamp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- GeropharmIndustry (pharma, biotech, devices)
- Study start
- 18 Jul 2017 (actual)
- Primary completion
- 24 Oct 2017 (actual)
- Study completion
- 24 Oct 2017 (actual)
- First posted
- 5 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- two-period two-way crossover
| Arm | Type | Receives |
|---|---|---|
| Rinsulin® mix 30/70 | Experimental | Drug: Rinsulin® mix 30/70, Drug: Humulin® M3Single subcutaneous administration of Insulin at a dose 0.4 IU / kg |
| Humulin® M3 | Active comparator | Drug: Rinsulin® mix 30/70, Drug: Humulin® M3Single subcutaneous administration of Insulin at a dose 0.4 IU / kg |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (22 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rinsulin® mix 30/70one subcutaneous injection at a dose of 0.4 IU/kg | Drug | Humulin® M3, Rinsulin® mix 30/70 |
| Humulin® M3one subcutaneous injection at a dose of 0.4 IU/kg | Drug | Humulin® M3, Rinsulin® mix 30/70 |
Primary outcome
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
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
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
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
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
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
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
11 secondary outcomes
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
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
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
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
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rinsulin® mix 30/70 and Humulin® M3 in people with Bioequivalence, run by Geropharm at 3 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2020.