A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Lispro to Humalog® in Healthy Subjects

NCT03604575 | Completed

• 1 other identifier: LISPRO-CL
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

Pharmacokinetics and pharmacodynamics study Study of 2 formulation of insulin lispro (Insulin Lispro GEROPHARM vers. Humalog® Eli Lilly)

Conditions

Clamp Study

Keywords

Pharmacokinetics; Pharmacodynamics; Insulin Lispro

Outcome Measures

Primary Outcomes (4)

• Cmax

  Pharmacokinetics of insulin lispro by Assessment of Observed Maximum Plasma Concentration (Cmax)

  -60, -30 and 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose

• AUC(0-t)

  Pharmacokinetics of insulin Lispro by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))

  -60, -30 and 0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose

• GIRmax

  Pharmacodynamic of insulin lispro by Maximum Glucose Infusion Rate (GIRmax)

  0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose

• AUCGIR0-t

  Pharmacodynamic of insulin Lispro by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))

  0 hours (pre-dose), as well as at, 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 165, 180, 210, 240, 270, 300, 360, 420 and 480 minutes post-dose

Study Arms (2)

Insulin Lispro

EXPERIMENTAL

Single subcutaneous administration of Insulin Lispro in dose 0.3 IU / kg

Drug: Insulin Lispro

Humalog®

ACTIVE COMPARATOR

Single subcutaneous administration of Humalog® in dose 0.3 IU / kg

Drug: Humalog®

Interventions

Insulin Lispro DRUG

Insulin Lispro

Humalog® DRUG

Also known as: insulin lispro

Humalog®

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: In women of childbearing age, the cyclicity of the hormonal status may affect insulin sensitivity at different stages of the study. Therefore, to exclude the influence of the cyclicity factor of the menstrual period on insulin sensitivity in women, only males have been included in the this study.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent.
• Caucasian males having a confirmed healthy diagnosis as per data of standard clinical, laboratory, and instrumental examination methods.
• Age of 18-50 (both incl.).
• Body mass index equal to 18.5-27.0 kg/m2.
• Volunteers' consent to all restrictions imposed during the study, including adequate methods of contraception.

You may not qualify if:

• Acute inflammatory diseases within 3 weeks before the screening period
• Episodes of hypoglycemia in the anamnesis, or the presence in the family history of cases of a verified diagnosis of diabetes mellitus in the immediate family
• Fasting plasma glucose\> 6.1 mmol / L
• HbA1C\> 6%
• Oral glucose tolerance test - blood glucose level ≥ 7.8 mmol / l (2 hours after loading with glucose)
• Deep vein thrombosis of lower extremities in a history of life or in a family history.
• Nicotine dependence (use of tobacco less than 6 months before the start of screening)
• Taking medications, phytopreparations, biologically active supplements less than 14 days before screening
• Receiving more than 10 units. alcohol per week (1 unit of alcohol is equivalent to 0.5 liters of beer, 200 ml of wine or 50 ml of strong alcohol) or anamnestic information about alcoholism.
• Donor blood donation in excess of 450 ml, less than 2 months before the study.
• Participation in a clinical trial of any medications less than 3 months before the start of screening
• Positive test results for hepatitis C or hepatitis B, HIV, syphilis.
• Anamnesis information about drug and / or drug dependence and / or substance abuse.
• Positive test for alcohol content in the exhaled air.
• A positive test for the content of drugs in the urine.

Sponsors & Collaborators

• Geropharm: lead

Study Sites (1)

LLL "BioEq"

Saint Petersburg, 197342, Russia

Location

MeSH Terms

Interventions

Insulin Lispro

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study was blinded for Sponsor, investigators and analytical laboratory
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: two-way crossover

Study Record Dates

• First Submitted: July 17, 2018
• First Posted: July 27, 2018
• Study Start: August 22, 2016
• Primary Completion: December 26, 2016
• Study Completion: December 26, 2016
• Last Updated: July 27, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)