Our team and certificates

Olesya Zinych, PhD, DMSc

Olesya Zinych, PhD, DMSc

Principal investigator
Vadym Korpachev, PhD, DMSc

Vadym Korpachev, PhD, DMSc

Principal investigator
Nataliya Kushnarova, PhD

Nataliya Kushnarova, PhD

Investigator, Study Coordinator
Alla Kovalchuk, PhD

Alla Kovalchuk, PhD

Investigator
Olha Prybyla, MD

Olha Prybyla, MD

Investigator
Kateryna Shyshkan-Shyshova, MD

Kateryna Shyshkan-Shyshova, MD

Investigator

Olesya Zinych

Principal investigator

Contact

Phone

Main: +380 442541284

Mob: +380 976444044

FAX Number

Main: +380444301036

Email

Primary: o.v.zinych@gmail.com

Facility Affiliation

State Institution “Institute of Endocrinology and Metabolism named after V.P. Komisarenko of National Academy of Medical Scienceof Ukraine”

Department of Aging endocrinology and Clinical Pharmacology

69 Vyshhorodska Str., Kyiv, 04114, Ukraine

Education and Training (List all Colleges, Universities and Medical Schools attended, postdoctoral/fellowship training, board certification/medical license)

Name and Location of Institution (City, State or Province and Country)

Degree and Year Awarded

Area of Study

P.L. Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine

Advanced course, the high category, 2015

Endocrinology

SI V.P.Komisarenko Institute of Endocrinology and Metabolism of Academy of Medical Sciences of Ukraine, Kyiv, Ukraine

DMSc, 2014

General Medicine      

P.L. Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine

Advanced course, the first category, 2009

Endocrinology

SI V.P.Komisarenko Institute of Endocrinology and Metabolism of Academy of Medical Sciences of Ukraine, Kyiv, Ukraine

PhD, 2007

General Medicine      

P.L. Shupyk National Medical Academy of Postgraduate Education, Kyiv, Ukraine

Endocrinologist, 2004

Endocrinology

National Medical University, Kyiv, Ukraine

MD

From: 1997 To: 2003

General Medicine      

Professional Experience

Position/Title

Name and Location of Institution

(City, State or Province and Country)

Dates

(Start/Stop Dates as applicable)

Current

Acting Head of Department of Aging endocrinology and Clinical Pharmacology

State Institution V.P.Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine, Unit of Clinical Pharmacology and Pharmacotherapy of Endocrine Diseases, Department of Age Pathology and Clinical Pharmacology, Kyiv, Ukraine

2019 – ongoing
Leadresearch fellow

State Institution V.P.Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine, Unit of Clinical Pharmacology and Pharmacotherapy of Endocrine Diseases, Department of Age Pathology and Clinical Pharmacology, Kyiv, Ukraine

2017-2019
Senior research fellow

State Institution V.P.Komisarenko Institute of Endocrinology and Metabolism of National Academy of Medical Sciences of Ukraine, Department of Age Pathology and Clinical Pharmacology (Unit of Department of Clinical Pharmacology and Pharmacotherapy of Endocrine Diseases), Kyiv, Ukraine

2011-ongoing
Previous

Junior research fellow

SI V.P.Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine, of Department of Clinical Pharmacology and Pharmacotherapy of Endocrine Diseases, Kyiv, Ukraine

2005-2010
Physician

SI V.P.Komisarenko Institute of Endocrinology and Metabolism of NAMS of Ukraine, of Department of Clinical Pharmacology and Pharmacotherapy of Endocrine Diseases, Kyiv, Ukraine

2004-2005

Training

GCP Training

NIDA Clinical Trials Network (National Institute of Drug Abuse)

Date Started: Feb 21, 2011

Date Completed: Feb 21, 2011

The State Expert Center of the Ministry of Health of Ukraine

Date Started: Oct 4, 2012

Date Completed: Oct 5, 2012

Brookwood International Academy

Date Started: Sep 6, 2016

Date Completed: Sep 6, 2016

The State Expert Center of the Ministry of Health of Ukraine

Date Started: Oct 18, 2017

Date Completed: Oct 18, 2017

The Global Health Network

Date Started: Feb 8, 2018

Date Completed: Feb 8, 2018

Research Experience

Phase II, Phase III, Phase IV

Indication

  • Diabetes Mellitus
  • Diabetes Complications
  • Dyslipidemias
  • Obesity

Studies

1.NCT00968812
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

2.NCT01032629
CANVAS – CANagliflozin cardioVascular Assessment Study
Phase III: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Factors
Interventional: Completed

3.NCT01106651
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

4.NCT01106677
The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis – DPP-4 Inhibitor Comparator Trial)
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

5.NCT01809327
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

6.NCT01858532
Study Of Diabetic Nephropathy With Atrasentan
Phase III: Diabetic Nephropathy
Interventional: Active, not recruiting

7.NCT01989754
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Phase IV: Diabetes Mellitus, Type 2, Albuminuria
Interventional: Completed

8.NCT01768559
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Phase III: Type 2 Diabetes
Interventional: Completed

9.NCT01494987
Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

10.NCT01472185
Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

11.NCT01555164
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

12.NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Phase III: Type 2 Diabetes
Interventional: Completed

13.NCT00332488
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

14.NCT01544881
Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes
Phase I: Type 1 Diabetes Mellitus
Interventional: Completed

15.NCT01849289
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

16.NCT01513590
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

17.NCT01533428
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
Phase III: Diabetic Peripheral Neuropathy, Pain
Interventional: Completed

18.NCT01459809
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

19.NCT01897532
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
Phase IV: Diabetes Mellitus, Type 2
Interventional: Completed

20.NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Phase III: Type 2 Diabetes
Interventional: Completed

21.NCT02863419
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

22.NCT01481116
Efficacy and Safety of TAK-875 Compared to Glimepiride When Used With Metformin in Participants With Type 2 Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Terminated

23.NCT00690456
Effect of Rimonabant and Metformin Combination on Glycemic Control in Patients With Type 2 Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Terminated

24.NCT00736099
Safety and Efficacy of Linagliptin (BI 1356) as Monotherapy or in Combination in Type 2 DM
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

25.NCT00740051
A Randomised, db, Placebo-controlled Study of BI 1356 for 18 Weeks Followed by a 34 Week Double-blind Extension Period (Placebo Patients Switched to Glimepiride) in Type 2 Diabetic Patients for Whom Treatment With Metformin is Inappropriate
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

26.NCT00362323
Fenofibrate and Metformin Fixed Combination vs Metformin – FAME METFO
Phase III: Dyslipidemia/Glucose Metabolism Disorder
Interventional: Completed

27.NCT00332488
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

28.NCT00483730
Actovegin® Versus Placebo in Patients With Diabetic Polyneuropathy (AV-007-IM)
Phase III: Symptomatic Diabetic Peripheral Polyneuropathy
Interventional: Completed

29.NCT03071692
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Phase III: Type2 Diabetes, Dyslipidemia
Interventional: Recruiting

30.NCT03315143
Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Phase III: Type 2 Diabetes Mellitus, Chronic Kidney Diseases
Interventional: Recruiting

31.NCT03548987
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Phase III: Metabolism and Nutrition Disorder, Obesity
Interventional: Recruiting

Publications

In total  – more  than 120

Vadym Korpachev

Investigator

Academic title: MD,PhD, Doctor of medical science, professor
Present position Chief Researcher of the Age Endocrinology and Clinical Pharmacology Department of the State Institution “Institute of endocrinology and metabolism n.a. V.P. Komisarenko of the National Academy of Medical Science of Ukraine”
Business address 69, Vyshgorodska str., Kiev, 04114, Ukraine
Relevant education

(Type of degree and year of competition)

Kyiv medical Institute, Kyiv, USSR

MD, 1968

Relevant previous positions

(Name of institution and/or organization and year)

Head of  the Department of Clinical Pharmacology and Pharmacotherapy of Endocrine Disease, State Institution V.P. Komissarenko Institute of Endocrinology and Metabolism  of AMS of Ukraine, 1989-2019;

Senior Research Scientist of State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, 1982-1989;

Junior Research Scientist of State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, 1972-1982

Post Graduate Student of State Institution “Institute of endocrinology and metabolism named after V. Komisarenka of the Academy of Medical Science of Ukraine”, 1968-1972

Relevant job related training

(Year of attendance, type of qualification, e.g., specialist courses)

State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, Professor, Endocrinology, 2010

State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, DocMedSc, Endocrinology, 1992

State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, PhD, endocrinology, 1972

Relevant clinical trial and research experience PI: K-877-302, 2017 – ongoing

SI: EFC14875, 2018 – ongoing

SI: NN9536-4376, 2018 – ongoing

PI: GLP116174, 2015 – 2018

PI: BI1218.22, 2015-2018

PI: M11-352, 2015-2018

SI: NN9924-4224, 2016 – 2018

PI: ITCA650CLP107, 2014-2016

PI: MKC-TI-134, 2014-2015

PI: NN 1250-3587, 2013 – 2014

PI: 28431754DIA-3011, 2012-2015

PI: 28431754DIA-3011, 2012-2015

PI: NN 2211-3916, 2012 – 2013

PI: MKC-TI-171,2012-2013

PI: GS-US-259-0110, 2012-2013

PI: GS-US-259-0131, 2012-2013

PI: GS-US-259-0147, 2012-2013

PI: MKC-TI-175, 2012-2013

PI: MKC-TI-171, 2011-2013

PI: GS-US-259-0147, 2012-2013

PI: ТАК-875_304,2012-2014

PI: 28431754 DIA 3008, 2011-2017

PI: 28431754 DIA 3010,2011-2013

PI: 28431754 DIA 3009, 2011-2013

PI: NN 5401-3940, 2011 – 2012

PI: 28431754 DIA 3006, 2011-2012

PI: EFC12626, 2011-2013

PI: NN 1250-3672, 2010 – 2011

GCP training

(name of course,Date of GCP completion,  provider of GCP course)

“ICH Good Clinical Practice E6 (R2)”, Certificate No. 354001, The Global Health Network, online training,

08 feb 2018

Good Clinical Practice (GCP). Clinical trial regulation”, Certificate No. 3227, The State Expert Center of the MoH of Ukraine, Kyiv, Ukraine, 29 nov 2017

Essential Good Clinical Practice”, Brookwood International Academy, 06 sep 2016

Nataliya Kushnarova

Investigator, Study Coordinator

Phone +380 442541284
Email natalijakush@gmail.com
Facility Affiliation Institute of Endocrinology and Metabolism named after Komissarenko
Vyshhorodskaya Street 69, Kiev, 04114, Ukraine
Aging enocrinology and clinical pharmacology
Medical Education National Medical University O.O. Bogomolets

Ukraine
Medical Doctor

Year Started: 1994

Year Finished: 2000

Professional Experience Senior Research Fellow
Institute of Endocrinology and Metabolism named after Komissarenko
Ukraine

From: 2016

To: Present

Research Fellow
Institute of Endocrinology and Metabolism named after Komissarenko
Ukraine

From: 2014

To: 2015

Junior Reserch Fellow
Institute of Endocrinology and Metabolism named after Komissarenko
Ukraine

From: 2006

To: 2013

Medical Specialty
  • Endocrinology: Diabetes & Metabolism
  • Clinical Pharmacology & Therapeutics (All)

301
Ukraine

Issue Date: Dec 27, 2010

Expiration Date: Sep 21, 2020

GCP Training Brookwood International Academy

Date Started: Sep 5, 2016

Date Completed: Sep 5, 2016

Abbvie

Date Started: Jun 26, 2014

Date Completed: Jun 26, 2014

The State Expert Center of the Ministry of Health of Ukraine

Date Started: Oct 4, 2012

Date Completed: Oct 5, 2012

NIDA Clinical Trials Network (National Institute of Drug Abuse)

Date Started: Apr 26, 2011

Date Completed: Apr 26, 2011

The Global Health Network

Date Started: Feb 8, 2018

Date Completed: Feb 8, 2018

The State Expert Center of the Ministry of Health of Ukraine

Date Started: Oct 18, 2017

Date Started: Oct 18, 2017

Research Experience Phase II, Phase III, Phase IV
Indication
  • Diabetes Mellitus
  • Diabetes Complications
  • Obesity
  • Dyslipidemias

NCT01463397
Efficacy and Safety of SAR292833 Administration for 4 Weeks in Patients With Chronic Peripheral Neuropathic Pain
Phase II: Neuropathic Pain
Interventional: Completed

NCT01768559
Efficacy and Safety of Lixisenatide Versus Insulin Glulisine on Top of Insulin Glargine With or Without Metformin in Type 2 Diabetic Patients
Phase III: Type 2 Diabetes
Interventional: Completed

NCT01517412
Comparison of Lixisenatide Injected Prior to the Main Meal of the Day Versus Prior to Breakfast in Type 2 Diabetic Patients on Metformin
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01147250
Evaluation of Cardiovascular Outcomes in Patients With Type 2 Diabetes After Acute Coronary Syndrome During Treatment With AVE0010 (Lixisenatide)
Phase III: Acute Coronary Syndrome
Interventional: Completed

NCT01494987
Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01472185
Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01555164
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
Phase III: Type 2 Diabetes Mellitus
Interventional: Completed

NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Phase III: Type 2 Diabetes
Interventional: Completed

NCT01858532
Study Of Diabetic Nephropathy With Atrasentan
Phase III: Diabetic Nephropathy
Interventional: Terminated

NCT01459133
Single Site, Single Subject, Treatment IND With Mannkind Corporation’s Technosphere Inhalation System
Diabetes
Interventional: Withdrawn

NCT00332488
Efficacy and Safety of Prandial Inhalation of Technosphere/Insulin in Combination With Metformin or Technosphere/Insulin Alone Versus 2 Oral Anti-Diabetic Agents in Subjects With Type 2 Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01544881
Comparison of Technosphere Insulin Inhalation Powder & Subcutaneous Rapid-Acting Analog in Subjects With Type 1 Diabetes
Phase I: Type 1 Diabetes Mellitus
Interventional: Completed

NCT01849289
A Trial Comparing Efficacy and Safety of Insulin Degludec and Insulin Glargine in Insulin naïve Subjects With Type 2 Diabetes
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT01620489
Efficacy and Safety of Liraglutide Versus Placebo as add-on to Existing Diabetes Medication in Subjects With Type 2 Diabetes and Moderate Renal Impairment
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT01513590
A Trial Comparing Efficacy and Safety of Insulin Degludec/Insulin Aspart and BIAsp 30 in Insulin naïve Subjects With Type 2 Diabetes
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT01533428
A Study to Evaluate Efficacy and Safety of a Single Application of Capsaicin 8%Transdermal Delivery System Compared to Placebo in Reducing Pain Intensity in Subjects With Painful Diabetic Peripheral Neuropathy (PDPN)
Phase III: Diabetic Peripheral Neuropathy, Pain
Interventional: Completed

NCT01459809
Efficacy and Safety Comparison of Metformin/Glimepiride Combination Versus Each Compound Alone in New Diagnosed Type 2 Diabetes Patients
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT00379769
RECORD: Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycaemia in Diabetes
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01897532
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
Phase IV: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01032629
CANVAS – CANagliflozin cardioVascular Assessment Study
Phase III: Diabetes Mellitus, Type 2, Cardiovascular Diseases, Risk Factors
Interventional: Completed

NCT01809327
A Study to Evaluate the Effectiveness, Safety, and Tolerability of Canagliflozin in Combination With Metformin in the Treatment of Patients With Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT00968812
CANagliflozin Treatment And Trial Analysis-Sulfonylurea (CANTATA-SU) SGLT2 Add-on to Metformin Versus Glimepiride
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01106651
A Safety and Efficacy Study of Canagliflozin in Older Patients (55 to 80 Years of Age) With Type 2 Diabetes Mellitus
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01106677
The CANTATA-D Trial (CANagliflozin Treatment and Trial Analysis – DPP-4 Inhibitor Comparator Trial)
Phase III: Diabetes Mellitus, Type 2
Interventional: Completed

NCT01989754
A Study of the Effects of Canagliflozin (JNJ-28431754) on Renal Endpoints in Adult Participants With Type 2 Diabetes Mellitus
Phase IV: Diabetes Mellitus, Type 2, Albuminuria
Interventional: Completed

NCT01455896
A Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Treated With ITCA 650
Phase III: Type 2 Diabetes
Interventional: Completed

NCT02863419
Efficacy and Safety of Oral Semaglutide Versus Liraglutide and Versus Placebo in Subjects With Type 2 Diabetes Mellitus
Phase III: Diabetes, Diabetes Mellitus, Type 2
Interventional: Completed

NCT03315143
Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Moderate Renal Impairment Who Are at Cardiovascular Risk
Phase III: Type 2 Diabetes Mellitus, Chronic Kidney Diseases
Interventional: Active, not recruiting

NCT03548987
Research Study Investigating How Well Semaglutide Works in People Suffering From Overweight or Obesity
Phase III: Metabolism and Nutrition Disorder, Obesity
Interventional: Active, not recruiting

NCT03882970
A Study of Tirzepatide (LY3298176) Versus Insulin Degludec in Participants With Type 2 Diabetes
Phase III: Type 2 Diabetes Mellitus
Interventional: Active, not recruiting

NCT03819153
A Research Study to See How Semaglutide Works Compared to Placebo in People With Type 2 Diabetes and Chronic Kidney Disease
Phase III: Diabetes Mellitus, Type 2
Interventional: Recruiting

NCT01897532
Cardiovascular and Renal Microvascular Outcome Study With Linagliptin in Patients With Type 2 Diabetes Mellitus (CARMELINA)
Phase IV: Diabetes Mellitus, Type 2
Interventional: Completed

NCT03071692
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)
Phase III: Type2 Diabetes, Dyslipidemia
Interventional: Recruiting

Alla Kovalchuk

Investigator

Academic title: PhD
Present position Leading research worker of the Age Endocrinology and Clinical Pharmacology Department of the State Institution “Institute of endocrinology and metabolism n.a. V.P. Komisarenko of the National Academy of Medical Science of Ukraine”
Business address 69, Vyshgorodska str., Kiev, 04114, Ukraine
Relevant education

(Type of degree and year of competition)

National medical university, Ukraine

MD, 1988

Relevant previous positions

(Name of institution and/or organization and year)

Senior Research Scientist of State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, 2007-2013;

Research Scientist of State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, 1993-2006;

Junior Research Scientist of State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, 1988-1993;

Relevant job related training

(Year of attendance, type of qualification, e.g., specialist courses)

State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, PhD, medicine, 2009

National Medical Academy of Postgraduate Education,  Advanced course, Ukraine, 2011, Endocrinology

National Medical Academy of Postgraduate Education,  Advanced course, Ukraine, 2013, Endocrinology

the high category endocrinologist

Relevant clinical trial and research experience SI: K-877-302, 2017 – ongoing

SI: NN9536-4376, 2018 – ongoing

SI: EFC14875, 2018 – ongoing

SI: GLP116174, 2015 – 2018

SI: BI1218.22, 2015-2018

SI: NN9924-4224, 2016 – 2018

SI: ITCA650CLP107, 2014-2016

SI: NN 1250-3587, 2013 – 2014

SI: 28431754DIA-3011, 2012-2015

SI: 28431754DIA-3011, 2012-2015

SI: GS-US-259-0110, 2012-2013

SI: GS-US-259-0131, 2012-2013

SI: MKC-TI-175, 2012-2013

SI: MKC-TI-171, 2011-2013

SI: ТАК-875_304,2012-2014

SI: 28431754 DIA 3008, 2011-2017

SI: 28431754 DIA 3010,2011-2013

SI: 28431754 DIA 3009, 2011-2013

SI: NN 5401-3940, 2011 – 2012

SI: 28431754 DIA 3006, 2011-2012

SI: EFC12626, 2011-2013

SI: NN 1250-3672, 2010 – 2011

GCP training

(name of course,Date of GCP completion,  provider of GCP course)

ICH Good Clinical Practice E6 (R2)”, Certificate No. 354315, The Global Health Network, online training, 09 feb 2018

Good Clinical Practice (GCP). Clinical trial regulation”, Certificate No. 3044, The State Expert Center of the MoH of Ukraine, Kyiv, Ukraine, 18 oct 2017

Good Clinical Practice (GCP). Legal and Regulatory Requirements and Ethical Aspects of Clinical Trial Conducting”, Certificate No. 032, The State Expert Center of the MoH of Ukraine, Kyiv, Ukraine, 29 nov 2014

Olha Prybyla

Investigator

Present Position: Junior Research Scientist of the Age Endocrinology and Clinical Pharmacology Department of the State Institution “Institute of endocrinology and metabolism n.a. V.P. Komisarenko of the National Academy of Medical Science of Ukraine”,
Business Address: 69, Vyshgorodska Str., Kyiv, 04114 Ukraine
Relevant Education:
(type of degree and year when awarded)
MD, National Medical Universitat, Kyiv, Ukraine, 2011
Relevant Previous Positions:
(name of institution and/or organisation and year)
Junior Research Scientist of State Institution “Institute of endocrinology and metabolism named after V.Komisarenka of the Academy of Medical Science of Ukraine”, 2012-present time
Relevant Job Related Training:
(year of completion, type of qualification; e.g. specialist courses)
Kyiv Medical Academy of Postgraduate Education,  Ukraine, 2012, Endocrynology

National Medical Academy of Postgraduate Education,  Advanced course, Ukraine, 2016, Endocrinology –

the second category endocrinologist

National Medical Academy of Postgraduate Education,  Advanced course, Ukraine, 2018, Endocrinology –

the first category endocrinologist

Relevant Clinical Trial(s) and Research Experience: SI: K-877-302, 2017 – ongoing

SI: NN9536-4376, 2018 – ongoing

SI: EFC14875, 2018 – ongoing

SI: BI1218.22, 2015-2018

SI: NN9924-4224, 2016 – 2018

SI: ITCA650CLP107, 2014-2016

SI: MKC-TI-134, 2014-2015

SI: NN 1250-3587, 2013 – 2014

Documentation of GCP training
(The name of GCP training; its provider and year of completion must be stated in the CV and/or a certificate of GCP training must be enclosed. The provider of GCP training can be internal, external, NN clinical staff ect.)
“ICH Good Clinical Practice E6 (R2)”, Certificate No. 354281, The Global Health Network, online training,

09 feb 2018

“Good Clinical Practice (GCP). Clinical trial regulation”, Certificate No. 3037, The State Expert Center of the MoH of Ukraine, Kyiv, Ukraine, 18 oct 2017

“Essential Good Clinical Practice”, Brookwood International Academy, online training, 05 sep 2016

Kateryna Shyshkan-Shyshova

Investigator

Present position Junior research fellow, State Institution V.P.Komisarenko Institute of Endocrinology and Metabolism of National Academy of Medical Sciences of Ukraine, Department of Age Pathology and Clinical Pharmacology Kyiv, Ukraine,

2015 – ongoing

Business address 69, Vyshgorodska str., Kiev, 04114, Ukraine
Relevant education

(Type of degree and year of competition)

National Medical University named after O.O. Bohomolets, Kyiv, Ukraine MD, 2008
Relevant previous positions

(Name of institution and/or organization and year)

Laboratory assistant with higher education, State Institution V.P.Komisarenko Institute of Endocrinology and Metabolism of National Academy of Medical Sciences of Ukraine, Department of Diabetology and Experimental Endocrinology, 2008-2014

Intern, National Medical University, Ukraine

Department of Internal Diseases, 2008-2010

Relevant job related training

(Year of attendance, type of qualification, e.g., specialist courses)

National Medical Academy of Postgraduate Education, Kyiv, Ukraine, Advanced course, Endocrinology (2013)
Relevant clinical trial and research experience SI: NN9924-4224, 2016

SI: K-877-302, 2017-on-going

SI: EFC14875, 2017-on-going

SI: NN9536-4376, 2018 – on-going

SI: I8F-MC-GPGH, 2019 – on-going

GCP training

(name of course,Date of GCP completion,  provider of GCP course)

GCP, The State Expert centre of MoH of Ukraine, 18-Oct-2017

GCP, The State Expert centre of MoH of Ukraine, 16-Feb-2016