NCT04184492

Brief Summary

Pharmacokinetics and pharmacodynamics study of 2 formulations of biphasic insulin aspart 30 (GP-40081 GEROPHARM vers. NovoMix® 30 Penfill® Novo Nordisk)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2019

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 15, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 28, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 29, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
Last Updated

December 3, 2019

Status Verified

November 1, 2019

Enrollment Period

2 months

First QC Date

November 29, 2019

Last Update Submit

November 29, 2019

Conditions

Clamp Study

Keywords

PharmacokineticsPharmacodynamicsBiphasic Insulin Aspart

Outcome Measures

Primary Outcomes (2)

  • AUC(0-t)

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

    -60, -30, 0 minutes (pre-dose) and 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 210, 240, 270, 300, 360, 420, 480, 600, 720, 960, 1200 and 1440 minutes post-dose

  • Cmax

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

    -60, -30, 0 minutes (pre-dose) and 15, 30, 45, 60, 75, 90, 105, 120, 135, 150, 180, 210, 240, 270, 300, 360, 420, 480, 600, 720, 960, 1200 and 1440 minutes post-dose

Study Arms (2)

GP-40081

EXPERIMENTAL

Single subcutaneous administration of GP-40081 in dose 0.4 IU / kg

Drug: GP-40081

NovoMix® 30 Penfill®

ACTIVE COMPARATOR

Single subcutaneous administration of NovoMix® 30 Penfill® in dose 0.4 IU / kg

Drug: NovoMix® 30 Penfill®

Interventions

GP-40081DRUG

biphasic insulin aspart 30 in doses 0.4 IU/kg

Also known as: biphasic insulin aspart 30
GP-40081
NovoMix® 30 Penfill®DRUG

biphasic insulin aspart 30 in doses 0.4 IU/kg

Also known as: biphasic insulin aspart 30
NovoMix® 30 Penfill®

Eligibility Criteria

Age18 Years - 45 Years
Sexmale(Gender-based eligibility)
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 18-45 (both incl.).
  • Body mass index equal to 18.5-30.0 kg/m2, body weight equal to 60.0-100.0 kg (both incl.).
  • Volunteers' consent to all restrictions imposed during the study, including adequate methods of contraception.
  • Russian citizenship.

You may not qualify if:

  • Weighed allergic anamnesis.
  • Increased sensitivity in the history of heparin, insulin or any of the excipients of the study drugs.
  • Any acute and chronic diseases (for 4 weeks before screening) incl.:
  • of the cardiovascular system, bronchopulmonary, neuroendocrine systems, as well as diseases of the gastrointestinal tract, liver, kidneys, blood.
  • positive tests: hepatitis B (Ag), hepatitis C (Ab), HIV (Ab), syphilis (Ab).
  • Deviations in basic vital signs: heart rate (60-89), systolic blood pressure (90-139 mm Hg), the diastolic blood pressure (60-89 mm Hg), respiratory rate (12-20), body temperature (35.7-37.2 C).
  • Abnormalities of the ECG from the norms.
  • Episodes of hypoglycemia in the anamnesis; 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% (screening).
  • 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.
  • Any diet (vegetarian, etc.), extreme physical exercise, night shift work.
  • Subjects who have taken any drugs known effects on hemodynamics or to induce or inhibit hepatic drug metabolism within 2 months prior to screening.
  • Taking medications, phytopreparations, biologically active supplements less than 14 days before screening.
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Endocrinology Research Centre

Moscow, 117036, Russia

Location

Almazov National Medical Research Centre

Saint Petersburg, 197341, Russia

Location

MeSH Terms

Interventions

insulin aspart, insulin aspart protamine drug combination 30:70

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

November 29, 2019

First Posted

December 3, 2019

Study Start

April 15, 2019

Primary Completion

June 28, 2019

Study Completion

June 28, 2019

Last Updated

December 3, 2019

Record last verified: 2019-11

Data Sharing

IPD Sharing
Will not share

Locations

RU(2)