Clinical trial NCT03606018: A Study to Compare Pharmacokinetics and Pharmacodynamics of Insulin Lispro Mix 25 to Humalog® Mix 25 in Healthy Subjects
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clamp Study
Keywords: Pharmacokinetics
Pharmacodynamics
Insulin Lispro
Lead sponsor: Geropharm
Sponsor class: INDUSTRY
First posted: 2018-07-30
Enrollment: 48
Sex: MALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: two-way crossover
Primary purpose: BASIC_SCIENCE

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)

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

Eligibility 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.

Primary outcomes:
measure: Cmax
timeFrame: -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
measure: AUC(0-t)
timeFrame: -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
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: FSBI"ENDOCRINOLOGY NMRC" Ministry of Health of the Russian Federation
city: Saint Petersburg
country: Russian Federation
facility: LLL "BioEq"
Study officials:
References: