NCT03606018

Brief Summary

Pharmacokinetics and pharmacodynamics study Study of 2 formulation of insulin lispro mix 25 (Insulin Lispro Mix 25 GEROPHARM vers. Humalog® Mix 25 Eli Lilly)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

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

April 12, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 13, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2017

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

July 20, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 30, 2018

Completed
Last Updated

July 31, 2018

Status Verified

July 1, 2018

Enrollment Period

3 months

First QC Date

July 20, 2018

Last Update Submit

July 30, 2018

Conditions

Clamp Study

Keywords

PharmacokineticsPharmacodynamicsInsulin Lispro

Outcome Measures

Primary Outcomes (2)

  • Cmax

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

    -0.5, 0 hour (pre-dose) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14 hour 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))

    -0.5, 0 hour (pre-dose) and 0.25, 0.5, 0.75, 1, 1.25, 1.5, 1.75, 2, 2.25, 2.5, 2.75, 3, 3.25, 3.5, 3.75, 4, 4.25, 4.5, 4.75, 5, 5.25, 5.5, 5.75, 6, 6.5, 7, 7.5, 8, 8.5, 9, 9.5, 10, 10.5, 11, 11.5, 12, 12.5, 13, 13.5, 14 hour post-dose

Study Arms (2)

Insulin Lispro Mix 25

EXPERIMENTAL

Single subcutaneous administration of Insulin Lispro Mix 25 in dose 0.4 IU / kg

Drug: Insulin Lispro Mix 25

Humalog® Mix 25

ACTIVE COMPARATOR

Single subcutaneous administration of Humalog® Mix 25 in dose 0.4 IU / kg

Drug: Humalog® Mix 25

Interventions

Insulin Lispro Mix 25DRUG

insulin lispro biphasic in doses 0.4 ME/kg

Also known as: insulin lispro biphasic
Insulin Lispro Mix 25
Humalog® Mix 25DRUG

insulin lispro biphasic in doses 0.4 ME/kg

Also known as: insulin lispro biphasic
Humalog® Mix 25

Eligibility Criteria

Age18 Years - 50 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsIn 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 VolunteersYes
Age GroupsAdult (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.
  • +9 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

FSBI"ENDOCRINOLOGY NMRC" Ministry of Health of the Russian Federation

Moscow, Russia

Location

LLL "BioEq"

Saint Petersburg, 197342, Russia

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study was blinded for Sponsor, investigators and analytical laboratory
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: two-way crossover
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 20, 2018

First Posted

July 30, 2018

Study Start

April 12, 2017

Primary Completion

July 13, 2017

Study Completion

July 13, 2017

Last Updated

July 31, 2018

Record last verified: 2018-07

Locations

RU(2)