Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 334 for:    lispro
Previous Study | Return to List | Next Study

A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Lispro Mix 25 to Humalog® Mix 25 in Healthy Subjects

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03606018
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : July 31, 2018
Sponsor:
Information provided by (Responsible Party):
Geropharm

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)

Condition or disease Intervention/treatment Phase
Clamp Study Drug: Insulin Lispro Mix 25 Drug: Humalog® Mix 25 Not Applicable

Detailed Description:
A randomized duble blinded two-way crossover single-dose pharmacokinetics and pharmacodynamics study of Insulin Lispro Mix 25 (LLC "GEROPHARM", Russia) versus Humalog® Mix 25 (Eli Lilly) in normal healthy subjects using the euglycemic clamp technique

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: two-way crossover
Masking: Single (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 Mix 25 (LLC "GEROPHARM", Russia) Versus Humalog® Mix 25 (Eli Lilly) in Healthy Subjects Using the Euglycemic Clamp Technique
Actual Study Start Date : April 12, 2017
Actual Primary Completion Date : July 13, 2017
Actual Study Completion Date : July 13, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Insulin Lispro Mix 25
Single subcutaneous administration of Insulin Lispro Mix 25 in dose 0.4 IU / kg
Drug: Insulin Lispro Mix 25
insulin lispro biphasic in doses 0.4 ME/kg
Other Name: insulin lispro biphasic

Active Comparator: Humalog® Mix 25
Single subcutaneous administration of Humalog® Mix 25 in dose 0.4 IU / kg
Drug: Humalog® Mix 25
insulin lispro biphasic in doses 0.4 ME/kg
Other Name: insulin lispro biphasic




Primary Outcome Measures :
  1. Cmax [ Time Frame: -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 ]
    Pharmacokinetics of insulin lispro by Assessment of Observed Maximum Plasma Concentration (Cmax)

  2. AUC(0-t) [ Time Frame: -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 ]
    Pharmacokinetics of insulin Lispro by Assessment of Area Under the Curve From Time Zero Extrapolated to "t" (AUC(0-t))



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   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
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  1. Acute inflammatory diseases within 3 weeks before the screening period
  2. 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
  3. Fasting plasma glucose> 6.1 mmol / L
  4. HbA1C> 6%
  5. Oral glucose tolerance test - blood glucose level ≥ 7.8 mmol / l (2 hours after loading with glucose)
  6. Deep vein thrombosis of lower extremities in a history of life or in a family history.
  7. Nicotine dependence (use of tobacco less than 6 months before the start of screening)
  8. Taking medications, phytopreparations, biologically active supplements less than 14 days before screening
  9. 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.
  10. Donor blood donation in excess of 450 ml, less than 2 months before the study.
  11. Participation in a clinical trial of any medications less than 3 months before the start of screening
  12. Positive test results for hepatitis C or hepatitis B, HIV, syphilis.
  13. Anamnesis information about drug and / or drug dependence and / or substance abuse.
  14. Positive test for alcohol content in the exhaled air.
  15. A positive test for the content of drugs in the urine.
  16. Presence of suspicions of an inflammatory disease of the urinary system as a result of urinalysis.
  17. Presence of mental illnesses in the anamnesis.
  18. Mental, physical and other reasons that do not allow to adequately assess their behavior and properly fulfill the conditions of the research protocol.
  19. Any other conditions that make it difficult, according to the informed opinion of the investigating physician, that volunteer participation in studies
  20. Increased sensitivity in the history of heparin, insulin or any of the excipients of the study drugs
  21. Weighed allergic anamnesis
  22. Abnormalities of the ECG and laboratory parameters from the norms
  23. 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
  24. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03606018


Locations
Layout table for location information
Russian Federation
FSBI"ENDOCRINOLOGY NMRC" Ministry of Health of the Russian Federation
Moscow, Russian Federation
LLL "BioEq"
Saint Petersburg, Russian Federation, 197342
Sponsors and Collaborators
Geropharm
Layout table for additonal information
Responsible Party: Geropharm
ClinicalTrials.gov Identifier: NCT03606018    
Other Study ID Numbers: LISPRO-25-CL
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 31, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Geropharm:
Pharmacokinetics
Pharmacodynamics
Insulin Lispro
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin
Insulin, Globin Zinc
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs