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

Sponsor

Geropharm (Industry)

Overall Status

Completed

CT.gov ID

NCT03604575

Collaborator

(none)

Enrollment

Location

Arms

4.1

Actual Duration (Months)

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Clamp Study	Drug: Insulin Lispro Drug: Humalog®	N/A

Detailed Description

A randomized duble blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Lispro (LLC "GEROPHARM", Russia) versus Humalog® (Eli Lilly) in normal healthy subjects using the euglycemic clamp technique

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Intervention Model Description:

two-way crossovertwo-way crossover

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

This study was blinded for Sponsor, investigators and analytical laboratory

Primary Purpose:

Basic Science

Official Title:

A Randomized Duble Blinded Two-way Crossover Single-dose Pharmacokinetics and Pharmacodynamics Study of Insulin Lispro (LLC "GEROPHARM", Russia) Versus Humalog® (Eli Lilly) in Healthy Subjects Using the Euglycemic Clamp Technique

Actual Study Start Date :

Aug 22, 2016

Actual Primary Completion Date :

Dec 26, 2016

Actual Study Completion Date :

Dec 26, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Insulin Lispro Single subcutaneous administration of Insulin Lispro in dose 0.3 IU / kg	Drug: Insulin Lispro
Active Comparator: Humalog® Single subcutaneous administration of Humalog® in dose 0.3 IU / kg	Drug: Humalog® Other Names: insulin lispro

Arm

Intervention/Treatment

Experimental: Insulin Lispro

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

Drug: Insulin Lispro

Active Comparator: Humalog®

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

Drug: Humalog®

Other Names:

insulin lispro

Outcome Measures

Primary Outcome Measures

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]
Pharmacokinetics of insulin lispro by Assessment of Observed Maximum Plasma Concentration (Cmax)
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]
Pharmacokinetics of insulin Lispro by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))
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]
Pharmacodynamic of insulin lispro by Maximum Glucose Infusion Rate (GIRmax)
AUCGIR0-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]
Pharmacodynamic of insulin Lispro by Assessment of GIR Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

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.

Exclusion Criteria:

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.
Presence of suspicions of an inflammatory disease of the urinary system as a result of urinalysis.
Presence of mental illnesses in the anamnesis.
Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol.
Any other conditions that make it difficult, according to the informed opinion of the investigating physician, that volunteer participation in studies
Increased sensitivity in the history of heparin, insulin or any of the excipients of the study drugs
Weighed allergic anamnesis
Abnormalities of the ECG and laboratory parameters from the norms
Deviations in basic vital signs: systolic blood pressure is below 100 mm Hg. or above 130 mm Hg, the diastolic blood pressure is below 70 mm Hg. or above 90 mm Hg; heart rate less than 60 or greater than 80
Deviations in basic vital signs: systolic blood pressure <100 mmHg. or> 130 mm Hg, diastolic blood pressure <70 mm Hg. Art. or> 90 mm Hg. Art. heart rate <60 or> 80 per minute.