MedPath

Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

Phase 3
Completed
Conditions
Type 2 Diabetes Mellitus
Interventions
Drug: Placebo
Behavioral: Diet
Behavioral: Exercise
Registration Number
NCT01494987
Lead Sponsor
Gilead Sciences
Brief Summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when added to glimepiride on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable sulfonylurea or metformin therapy in addition to diet and exercise.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
431
Inclusion Criteria
  • Written informed consent

  • Males and females, 18 to 75 years old, inclusive

  • Documented history of T2DM

  • Receiving one of the following sulfonylurea or metformin therapies in addition to diet and exercise for at least 90 days prior to Screening:

    1. glimepiride at a daily dose of ≥ 2 mg and ≤ 4 mg
    2. glipizide, glyburide, or glibenclamide (or equivalent) at a daily dose of ≥ 7.5 mg
    3. gliclazide at a daily dose of > 160 mg (or ≥ 60 mg for the modified release [MR] formulation)
    4. metformin at a daily dose of ≥ 1500 mg
  • Body mass index (BMI) 25 kg/m2 to 45 kg/m2, inclusive, at Screening

  • HbA1c 7% to 10%, inclusive, at Screening and the end of the Qualifying Period (Day 14)

  • Fasting Serum C-peptide ≥ 0.8 ng/mL at Screening

  • Fasting serum glucose (FSG) ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period (Day 14): A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 120 mg/dL (6.7 mmol/L) and < 130 mg/dL (7.2 mmol/L) who are otherwise eligible as determined by the investigator.

  • Able and willing to comply with all study procedures during the course of the study

  • Females of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug.

  • At least 80% compliant in dosing during the Qualifying Period

Exclusion Criteria
  • History of or current diagnosis of type 1 diabetes mellitus
  • History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
  • History of a severe episode of hypoglycemia (≥ 1 episode within 3 months prior to Screening or ≥ 2 episodes within 6 months prior to Screening), defined as hypoglycemia requiring 3rd party assistance to actively administer carbohydrate, glucagon, or other resuscitative actions due to severe impairment in consciousness or behavior
  • Clinically significant complications of diabetes that in the judgment of the investigator would make the subject unsuitable to participate in this study
  • History of any clinically significant cardiovascular (CV) or cerebrovascular event (eg, myocardial infarction [MI], acute coronary syndrome [ACS], recent revascularization [including coronary artery bypass graft procedures or percutaneous coronary intervention], transient ischemic attack, or ischemic stroke) ≤ 3 months prior to Screening
  • Inadequately controlled or unstable hypertension as defined by a systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and at Randomization
  • Prolonged QT interval corrected for heart rate (QTc) interval > 500 msec by electrocardiogram (ECG) at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
  • History of bariatric surgery at any time in the past or or any other surgery < 2 months before Screening; or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the medical monitor.
  • Any other hospitalization in the 14 days prior to Screening or planned hospitalization at any time during the study
  • Significant weight change (± 5%) < 2 months prior to Screening or enrollment in a weight-loss program other than a maintenance phase at Screening.
  • Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation < 30 mL/min/1.73 m2 at Screening or undergoing any type of dialysis at Screening or planning to undergo any type of dialysis during the course of the study
  • History of liver cirrhosis (Child-Pugh Class A, B or C)
  • Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL
  • History of cancer (except nonmelanomic skin cancers or cervical in situ) within 5 years prior to Screening
  • History of alcohol or other drug abuse < 12 months prior to Screening
  • Any other clinically significant existing medical or psychiatric condition, including clinically significant laboratory abnormalities, or one requiring further evaluation that in the opinion of the investigator could interfere with conduct of the study or interpretation of the data
  • Use of antihyperglycemic agents other than sulfonylurea agents or metformin, including but not limited to dipeptidyl peptidase-4 inhibitors (eg, saxagliptin and sitagliptin), glucagon-like peptide-mimetics (eg, exenatide), or insulin < 3 months prior to Screening; use of thiazolidinediones (TZDs) (eg, rosiglitazone or pioglitazone) < 24 weeks prior to Screening
  • Previous history of intolerance of glimepiride (as a single-agent therapy)
  • Prior treatment with open-label ranolazine, or known hypersensitivity or intolerance to ranolazine or any of its excipients
  • Treatment with strong or moderate cytochrome P (CYP)3A inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization
  • Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization
  • Treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, or sirolimus) within 14 days prior to Randomization
  • Treatment with simvastatin at a dose of > 20 mg daily or lovastatin at a dose of > 40 mg daily within 14 days prior to Randomization
  • Weight loss medication or anti-obesity medication (prescription or non-prescription) < 3 months prior to Screening
  • Treatment with niacin > 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 3 months prior to Screening
  • Expected or current treatment with systemic corticosteroids (oral or injectable) for > 14 days from Screening through the end of the Treatment Period. Topical or inhaled corticosteroid formulations are permitted at any time during the study.
  • If receiving thyroid replacement therapy, should be on stable doses for at least 6 weeks prior to randomization
  • Hemoglobin < 12 g/dL for males or < 11 g/dL for females at Screening
  • Participation in another clinical study involving an investigational drug or device < 30 days prior to Screening; participation in another clinical study involving an oral antihyperglycemic agent (OHA) < 90 days prior to Screening
  • Donation of blood < 2 months prior to Screening or plans to donate blood while participating in the study
  • Females who are pregnant or are breastfeeding
  • Other condition(s) that, in the opinion of the investigator, would compromise the safety of the individual, prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or compromise the quality of the clinical study

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Placebo+glimepiridePlaceboGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks. Participants will be required to maintain their diet and exercise regimen.
Ranolazine+glimepirideDietGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive ranolazine 500 mg twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24. Participants will be required to maintain their diet and exercise regimen.
Ranolazine+glimepirideExerciseGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive ranolazine 500 mg twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24. Participants will be required to maintain their diet and exercise regimen.
Placebo+glimepirideExerciseGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks. Participants will be required to maintain their diet and exercise regimen.
Placebo+glimepirideDietGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks. Participants will be required to maintain their diet and exercise regimen.
Ranolazine+glimepirideRanolazineGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive ranolazine 500 mg twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24. Participants will be required to maintain their diet and exercise regimen.
Ranolazine+glimepirideGlimepirideGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive ranolazine 500 mg twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24. Participants will be required to maintain their diet and exercise regimen.
Placebo+glimepirideGlimepirideGlimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks. Participants will be required to maintain their diet and exercise regimen.
Primary Outcome Measures
NameTimeMethod
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24Baseline; Week 24

The average (mean) change from baseline in HbA1c at Week 24 was analyzed.

Secondary Outcome Measures
NameTimeMethod
Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24Baseline; Week 24

The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.

Mixed Meal Tolerance Test (MMTT) Full Analysis Set: randomized participants who received at least one dose of study treatment with a baseline and at least one postbaseline measurement of serum glucose at T=120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations, analyzed based on the randomized treatment regardless of actual treatment received.

Change From Baseline in Fasting Serum Glucose at Week 24Baseline; Week 24

The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.

Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24Baseline; Week 24

The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.

Trial Locations

Locations (139)

Clinical Research Advantage/Desert Clinical Research, LLC

🇺🇸

Mesa, Arizona, United States

Desert Sun Clinical Research, LLC

🇺🇸

Tucson, Arizona, United States

Southland Clinical Research Center, Inc.

🇺🇸

Fountain Valley, California, United States

Eclipse Clinical Research

🇺🇸

Tucson, Arizona, United States

Paul W. Davis, MD, PA

🇺🇸

Pine Bluff, Arkansas, United States

Del Rosario Medical Clinic, Inc.

🇺🇸

Huntington Park, California, United States

Valley Research

🇺🇸

Fresno, California, United States

Scripps Whittier Diabetes Institute

🇺🇸

La Jolla, California, United States

Spectrum Clinical Research Institute, Inc

🇺🇸

Moreno Valley, California, United States

Florida Research Network, LLC

🇺🇸

Gainesville, Florida, United States

NewPhase Clinical Trials, Inc.

🇺🇸

Miami Beach, Florida, United States

Sacramento Heart and Vascular Medical Associates

🇺🇸

Sacramento, California, United States

Infosphere Clinical Research

🇺🇸

West Hills, California, United States

PAB Clinical Research

🇺🇸

Brandon, Florida, United States

Regenerate Clinical Trials

🇺🇸

South Miami, Florida, United States

Comprehensive Clinical Development, Inc.

🇺🇸

St. Petersburg, Florida, United States

Clinical Research of Central Florida

🇺🇸

Winter Haven, Florida, United States

CTL Research

🇺🇸

Eagle, Idaho, United States

LaPorte County Institute for Clinical Research

🇺🇸

Michigan City, Indiana, United States

L-MARC Research Center

🇺🇸

Louisville, Kentucky, United States

Horizon Research Group of Opelousas

🇺🇸

Eunice, Louisiana, United States

MD Medical Research

🇺🇸

Oxon Hill, Maryland, United States

Endeavor Medical Research, PLC

🇺🇸

Alpena, Michigan, United States

IRC Clinics, Inc

🇺🇸

Towson, Maryland, United States

Albuquerque Clinical Trials

🇺🇸

Albuquerque, New Mexico, United States

Associated Internal Medicine Specialists, P.C.

🇺🇸

Battle Creek, Michigan, United States

PMG Research of Charlotte

🇺🇸

Charlotte, North Carolina, United States

PharmQuest

🇺🇸

Greensboro, North Carolina, United States

Clinical Inquest Center, Ltd.

🇺🇸

Beavercreek, Ohio, United States

Southeastern Research Associates, Inc.

🇺🇸

Taylors, South Carolina, United States

Holston Medical Group

🇺🇸

Kingsport, Tennessee, United States

The University of Texas Southwestern Medical Center at Dallas

🇺🇸

Dallas, Texas, United States

HCCA Clinical Research Solution

🇺🇸

Franklin, Tennessee, United States

New Phase Research & Development

🇺🇸

Knoxville, Tennessee, United States

Humble Cardiology Associates

🇺🇸

Humble, Texas, United States

Drug Research Center

🇭🇺

Balatonfüred, Hungary

Interni oddeleni

🇨🇿

Havirov, Moravskoslezsky kraj, Czech Republic

Synexus Hungary Ltd

🇭🇺

Budapest, Hungary

Kanizsai Dorottya Hospital

🇭🇺

Nagykanizsa, Hungary

Borbanya Praxis Kft., Outpatient Clinic

🇭🇺

Nyíregyháza, Hungary

Medifarma 98

🇭🇺

Nyíregyháza, Hungary

Hospital Universiti Sains Malaysia

🇲🇾

Kubang Kerian, Kelantan, Malaysia

NZOZ Centrum Medyczne Szpital Sw. Rodziny

🇵🇱

Lodz, Lodzkie, Poland

NZOZ Centrum Badan Klinicznych

🇵🇱

Wroclaw, Dolnoslaskie, Poland

Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna

🇵🇱

Lodz, Lodzkie, Poland

LANDA - Specjalistyczne Gabinety Lekarskie

🇵🇱

Krakow, Poland

SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi, Oddział Kliniczny Diabetologii

🇵🇱

Lodz, Poland

NZOZ Centrum Badan Klinicznych Oswiecim

🇵🇱

Oswięcim, Poland

Consultmed SRL

🇷🇴

Iasi, Jud. Iasi, Romania

Spital Clinic Judetean de Urgenta Oradea Stationarul 1

🇷🇴

Oradea, Jud Bihor, Romania

CMI Morosanu V. Magdalena

🇷🇴

Galati, Judetul Galati, Romania

Tehnomed Trading Srl

🇷🇴

Bucharest, Romania

O.D. Medica Srl

🇷🇴

Bucharest, Romania

Institutul de Diabet, Nutritie si Boli Metabolice "Dr. N. C. Paulescu"

🇷🇴

Bucuresti, Romania

Institutul National De Diabet, Nutritie Si Boli Metabolice "Prof. Dr. N.C. Paulescu"

🇷🇴

Bucuresti, Romania

CMI Mateescu S. Ana-Maria

🇷🇴

Constanta, Romania

Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati

🇷🇴

Galati, Romania

Diabmed Dr. Popescu Alexandrina SRL

🇷🇴

Ploiesti, Romania

GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF

🇷🇺

Chita, Russian Federation

3rd Central Military Clinical Hospital named after A.A.Vishnevskogo

🇷🇺

Arkhangelskoe, Russian Federation

"Clinic of New Medical Technology" Company Limited

🇷🇺

Dzerzhinskiy, Russian Federation

The Urals State Medical Academy

🇷🇺

Ekaterinburg, Russian Federation

Kemerovo Regional Clinical Hospital

🇷🇺

Kemerovo, Russian Federation

"Krasnoyarsk State Medical University n.a. Prof. V.F. Voyno-Yasenetsky

🇷🇺

Krasnoyarsk, Russian Federation

State Healthcare Institution of Moscow "Cardiologival Dispensary #2 of Management Department of South Administrative District"

🇷🇺

Moscow, Russian Federation

Central Clinical Hospital of Russian Academy of Sciences

🇷🇺

Moscow, Russian Federation

Medical Sanitary Unit of Minestry of Internal Affairs of Russia in Moscow

🇷🇺

Moscow, Russian Federation

Novosibirsk State Medical University

🇷🇺

Novosibirsk, Russian Federation

City Clinical Hospital # 13 of Avtozavodsky District of Nizhniy Novgorod

🇷🇺

Nizhniy Novgorod, Russian Federation

Scientific Research Institute of Physiology of Siberian Department RAMS

🇷🇺

Novosibirsk, Russian Federation

Rostov State Medical University

🇷🇺

Rostov-on-Don, Russian Federation

City Hospital # 38 named after N A Semashko

🇷🇺

Pushkin, Russian Federation

Medinet, LLC

🇷🇺

St. Petersburg, Russian Federation

Ryazan State Medical University

🇷🇺

Ryazan, Russian Federation

Smolensk State Medical Academy, Sanatorium-Preventorium

🇷🇺

Smolensk, Russian Federation

Center "Diabetes", LLC

🇷🇺

Samara, Russian Federation

North-Western State Medical Unversity n.a. I.I.Mechnikov

🇷🇺

St. Petersburg, Russian Federation

Saint-Petersburg City Outpatient Clinic#37

🇷🇺

St. Petersburg, Russian Federation

Military Medical Academy named after S.M. Kirov

🇷🇺

St. Petersburg, Russian Federation

Saint-Petersburg state budgetary healthcare institution "City Polyclinic #109"

🇷🇺

St. Petersburg, Russian Federation

Alexanders City Hospital

🇷🇺

St. Petersburg, Russian Federation

Clinical Hospital #122 n.a. Sokolov of FMBA

🇷🇺

St. Petersburg, Russian Federation

ANO "Medical Centre "XXI century"

🇷🇺

St. Petersburg, Russian Federation

St. Elizabeth City Hospital

🇷🇺

St. Petersburg, Russian Federation

Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov

🇷🇺

St. Petersburg, Russian Federation

Krestovsky Island Medical Institute, LLC

🇷🇺

St. Petersburg, Russian Federation

International Medical Center "SOGAZ", LLC

🇷🇺

St. Petersburg, Russian Federation

Saint-Petersburg City Pokrovskaya Hospital

🇷🇺

St. Petersburg, Russian Federation

Voronezh Regional Clinical Hospital #1

🇷🇺

Voronezh, Russian Federation

City Hospital named after N.A.Semashko

🇷🇺

Yaroslavl, Russian Federation

Tyumen State Medical Academy

🇷🇺

Tyumen, Russian Federation

Clinical Hospital for Emergency Care named after N.V. Solovyov

🇷🇺

Yaroslavl, Russian Federation

Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery

🇷🇺

Yaroslavl, Russian Federation

Yaroslavl Regional Clinical Hospital

🇷🇺

Yaroslavl, Russian Federation

Clinical Center of Serbia

🇷🇸

Belgrade, Serbia

Zvezdara University Medical Center

🇷🇸

Belgrade, Serbia

Clinical Center of Kragujevac

🇷🇸

Kragujevac, Serbia

METABOLKLINIK s.r.o.

🇸🇰

Bratislava, Bratislavsky kraj, Slovakia

ARETEUS s.r.o., Diabetologicka ambulancia

🇸🇰

Trebisov, Kosicky kraj, Slovakia

ENDIAMED s.r.o

🇸🇰

Dolny Kubin, Zilinsky kraj, Slovakia

Newkwa Medical Centre

🇿🇦

Newlands West, Durban, South Africa

Drs. Naiker and Naicker Inc.

🇿🇦

Overport, Durban, South Africa

MediVet s.r.o.

🇸🇰

Malacky, Slovakia

Centre for Diabetes and Endocrinology Suite 1

🇿🇦

Durban, South Africa

Centre for Diabetes, Asthma and Allergy

🇿🇦

Johannesburg, South Africa

Soweto Clinical Trial Centre

🇿🇦

Johannesburg, South Africa

Centre fro Diabetes and Endocrinology (Pty) Ltd

🇿🇦

Johannesburg, South Africa

Paarl Research Centre

🇿🇦

Paarl, Cape Town, South Africa

Aliwal Shoal Medical & Clinical Trial Centre

🇿🇦

Kwa Zulu Natal, South Africa

Helderberg Clinical Trials Centre

🇿🇦

Somerset West, South Africa

Tiervlei Trial Centre

🇿🇦

Western Cape, South Africa

Phramongkutklao Hospital

🇹🇭

Bangkok, Thailand

Rajavithi Hospital

🇹🇭

Bangkok, Thailand

Songklanagarind Hospital

🇹🇭

Songkla, Thailand

Educational Scientific Medical Centre "University clinic" of Donetsk National Medical University n.a. M.Gorkiy

🇺🇦

Donetsk, Ukraine

City Clinical Hospital#9, Dnipropetrovsk State Medical Academy

🇺🇦

Dnipropetrovsk, Ukraine

Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company

🇺🇦

Kyiv, Ukraine

National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clinic # 2 of Shevchenkovsky District

🇺🇦

Kyiv, Ukraine

V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine

🇺🇦

Kyiv, Ukraine

Zhytomyr Regional Clinical Hospital

🇺🇦

Zhytomyr, Ukraine

Lviv Regional Endocrinology Dispensary

🇺🇦

Lviv, Ukraine

Odessa State Medical University

🇺🇦

Odesa, Ukraine

Municipal Institution Lutsk City Clinical Hospital

🇺🇦

Lutsk, Ukraine

Chulalongkorn University

🇹🇭

Patumwan, Bangkok, Thailand

Synergy Therapeutic Partners

🇺🇸

Atlanta, Georgia, United States

Infinity Research Group, LLC

🇺🇸

Oklahoma City, Oklahoma, United States

Texas Center for Drug Development, Inc.

🇺🇸

Houston, Texas, United States

Cetero Research

🇺🇸

San Antonio, Texas, United States

National Research Institute

🇺🇸

Los Angeles, California, United States

Cedar-Crosse Research Center

🇺🇸

Chicago, Illinois, United States

Excel Clinical Research, LLC

🇺🇸

Houston, Texas, United States

Highland Clinical Research

🇺🇸

Salt Lake City, Utah, United States

Jean Brown Research

🇺🇸

Salt Lake City, Utah, United States

NZOZ Polimedica

🇵🇱

Zgierz, Lodzkie, Poland

Centrum Badan Klinicznych PI-House Sp. z o.o.

🇵🇱

Gdansk, Pomorskie, Poland

Markhot Ferenc Hospital

🇭🇺

Eger, Hungary

Centru Medical Dr. Negrisanu

🇷🇴

Timisoara, Judical Timis, Romania

Metabolic Center of Dr. Katarina Raslova Ltd.

🇸🇰

Bratislava, Bratislavsky kraj, Slovakia

Suncoast Clinical Research

🇺🇸

New Port Richey, Florida, United States

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