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

NCT04501250 | Completed DMC

• 1 other identifier: RINCL-NPH
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Pharmacokinetics; Bioequivalence

Keywords

human recombinant insulin; euglycemic hyperinsulinemic clamp

Outcome Measures

Primary Outcomes (7)

• Смах

  Test Drug Observed Maximum Plasma Concentration (Cmax)

  - 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

• AUC 0-12

  Total area under the curve "drug concentration - time" in the time interval from 0 to 12 h

  - 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

• AUC GIR 0-12

  Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 12 h

  -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

• AUC GIR 0-24

  Total area under the curve "glucose infusion rate - time" in the time interval from 0 to 24 h

  -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

• GIRmax

  Maximum glucose infusion rate over the study period

  -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

• tGIRmax

  Time to reach maximum glucose infusion rate

  -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

• tGIRlag

  Time between the drug administration and the onset of action

  -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

Secondary Outcomes (6)

• AUC 0-2

  - 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

• AUC 0-6

  - 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

• AUC 0-24

  - 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

• AUC 0-∞

  - 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

• Tmax

  - 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

Study Arms (2)

Rinsulin® NPH

EXPERIMENTAL

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

Drug: Rinsulin NPH; Drug: Humulin NPH

Humulin® NPH

ACTIVE COMPARATOR

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

Drug: Rinsulin NPH; Drug: Humulin NPH

Interventions

Rinsulin NPH DRUG

subcutaneous injection at a dose of 0.4 IU/kg

Humulin® NPH; Rinsulin® NPH

Humulin NPH DRUG

subcutaneous injection at a dose of 0.4 IU/kg

Humulin® NPH; Rinsulin® NPH

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: male
• 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 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).

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

Yarosslavl Clinical Hospital #3

Yaroslavl, Russia

Location

MeSH Terms

Interventions

Isophane Insulin, Human

Intervention Hierarchy (Ancestors)

Insulin, Isophane; Insulin, Long-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Insulin, Regular, Human; Insulin; Proinsulin; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Sergei Mr Noskov, AP of medicine

  Yaroslavl City Clinical Hospital No. 3

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Crossover Assignment two-way crossover

Study Record Dates

• First Submitted: August 3, 2020
• First Posted: August 6, 2020
• Study Start: October 23, 2017
• Primary Completion: January 1, 2018
• Study Completion: May 21, 2018
• Last Updated: August 6, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)