NCT06050343

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 19, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 4, 2018

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2020

Completed
3.1 years until next milestone

First Posted

Study publicly available on registry

September 22, 2023

Completed
Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

2 months

First QC Date

August 3, 2020

Last Update Submit

September 15, 2023

Conditions

BioequivalenceTherapeutic Equivalency

Keywords

human recombinant insulineuglycemic hyperinsulinemic clamp

Outcome Measures

Primary Outcomes (4)

  • Смах

    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

    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

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

  • GIRmax

    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 Outcomes (10)

  • tGIRmax

    -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

    -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours

  • AUC 0-4

    -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours

  • AUC 0-6

    -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours

  • Tmax

    -60 minutes, -30 minutes, 0, every 15 minutes till 4 hours and then every 30 minutes till 10 hours

  • +5 more secondary outcomes

Study Arms (2)

Rinsulin® R

EXPERIMENTAL

Single subcutaneous administration of Insulin at a dose 0.3 IU / kg

Drug: Humulin® RegularDrug: Rinsulin® R

Humulin® Regular

ACTIVE COMPARATOR

Single subcutaneous administration of Insulin at a dose 0.3 IU / kg

Drug: Humulin® RegularDrug: Rinsulin® R

Interventions

Humulin® RegularDRUG

subcutaneous injection at a dose of 0.3 IU / kg

Also known as: Reference drug
Humulin® RegularRinsulin® R
Rinsulin® RDRUG

subcutaneous injection at a dose of 0.3 IU / kg

Also known as: Test Drug
Humulin® RegularRinsulin® R

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (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).
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Moscow, 117036, Russia

Location

MeSH Terms

Interventions

Drug Evaluation

Intervention Hierarchy (Ancestors)

Drug DevelopmentInvestigative TechniquesEvaluation Studies as Topic

Study Design

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

Study Record Dates

First Submitted

August 3, 2020

First Posted

September 22, 2023

Study Start

February 19, 2018

Primary Completion

May 4, 2018

Study Completion

May 4, 2018

Last Updated

September 22, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)