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

NCT04498884 | Completed DMC

• 1 other identifier: RIN30-70-CL
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 3

Brief 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).

Conditions

Bioequivalence

Keywords

human recombinant insulin; euglycemic hyperinsulinemic clamp

Outcome Measures

Primary Outcomes (7)

• AUC 0-12

  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

  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

  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

  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

  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 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 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 Outcomes (11)

• AUC 0-2

  -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

  -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

  -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-∞

  -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

  -0.5 , 0, every 15 min till 6 h, every 30 min till 11h, every 60 min till 17h, every 120 min till 24h

Study Arms (2)

Rinsulin® mix 30/70

EXPERIMENTAL

Single subcutaneous administration of Insulin at a dose 0.4 IU / kg

Drug: Rinsulin® mix 30/70; Drug: Humulin® M3

Humulin® M3

ACTIVE COMPARATOR

Single subcutaneous administration of Insulin at a dose 0.4 IU / kg

Drug: Rinsulin® mix 30/70; Drug: Humulin® M3

Interventions

Rinsulin® mix 30/70 DRUG

one subcutaneous injection at a dose of 0.4 IU/kg

Humulin® M3; Rinsulin® mix 30/70

Humulin® M3 DRUG

one subcutaneous injection at a dose of 0.4 IU/kg

Humulin® M3; Rinsulin® mix 30/70

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Geropharm: lead

Study Sites (3)

"National Medical Research Center of Endocrinology" of the Ministry of Health of the Russian Federation

Moscow, 117036, Russia

Location

National Medical Research Center in name of V.A. Almazov " of the Ministry of Health of the Russian Federation

Saint Petersburg, 194156, Russia

Location

LLC "BioEk", Russian Federation

Saint Petersburg, 197342, Russia

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: douuble-blinded
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-period two-way crossover

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 5, 2020
• Study Start: July 18, 2017
• Primary Completion: October 24, 2017
• Study Completion: October 24, 2017
• Last Updated: August 5, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (3)