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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01494987
First received: December 15, 2011
Last updated: September 17, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes Mellitus
Drug: Ranolazine
Drug: Placebo
Drug: Glimepiride
Behavioral: Diet
Behavioral: Exercise
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Glimepiride in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline; Week 24 ] [ Designated as safety issue: No ]
    The average (mean) change from baseline in HbA1c at Week 24 was analyzed.


Secondary Outcome Measures:
  • Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24 [ Time Frame: Baseline; Week 24 ] [ Designated as safety issue: No ]

    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 24 [ Time Frame: Baseline; Week 24 ] [ Designated as safety issue: No ]
    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 24 [ Time Frame: Baseline; Week 24 ] [ Designated as safety issue: No ]
    The average (mean) change from baseline in 2-hour postprandial serum glucose at Week 24 was analyzed.


Enrollment: 431
Study Start Date: January 2012
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ranolazine+glimepiride

Glimepiride 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.

Drug: Ranolazine
Ranolazine tablet(s) administered orally
Other Name: Ranexa®
Drug: Glimepiride
Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.
Behavioral: Diet
Participants are instructed to continue the diet regimen prescribed by their physician.
Behavioral: Exercise
Participants are instructed to continue the exercise regimen prescribed by their physician.
Placebo Comparator: Placebo+glimepiride

Glimepiride 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.

Drug: Placebo
Placebo to match ranolazine for the duration of the study
Drug: Glimepiride
Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.
Behavioral: Diet
Participants are instructed to continue the diet regimen prescribed by their physician.
Behavioral: Exercise
Participants are instructed to continue the exercise regimen prescribed by their physician.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 CYP3A 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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01494987

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Locations
United States, Arizona
Clinical Research Advantage/Desert Clinical Research, LLC
Mesa, Arizona, United States, 85213
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States, 85710
Eclipse Clinical Research
Tucson, Arizona, United States, 85745
United States, Arkansas
Paul W. Davis, MD, PA
Pine Bluff, Arkansas, United States, 71603
United States, California
Southland Clinical Research Center, Inc.
Fountain Valley, California, United States, 92708
Valley Research
Fresno, California, United States, 93720-2992
Del Rosario Medical Clinic, Inc.
Huntington Park, California, United States, 90255
Scripps Whittier Diabetes Institute
La Jolla, California, United States, 92037
National Research Institute
Los Angeles, California, United States, 90057
Spectrum Clinical Research Institute, Inc
Moreno Valley, California, United States, 92553
Sacramento Heart and Vascular Medical Associates
Sacramento, California, United States, 95825
Infosphere Clinical Research
West Hills, California, United States, 91307
United States, Florida
PAB Clinical Research
Brandon, Florida, United States, 33511
Florida Research Network, LLC
Gainesville, Florida, United States, 32605-4253
NewPhase Clinical Trials, Inc.
Miami Beach, Florida, United States, 33140
Suncoast Clinical Research
New Port Richey, Florida, United States, 34652
Regenerate Clinical Trials
South Miami, Florida, United States, 33143
Comprehensive Clinical Development, Inc.
St. Petersburg, Florida, United States, 33716
Clinical Research of Central Florida
Winter Haven, Florida, United States, 33880
United States, Georgia
Synergy Therapeutic Partners
Atlanta, Georgia, United States, 30127
United States, Idaho
CTL Research
Eagle, Idaho, United States, 83616
United States, Illinois
Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
United States, Indiana
LaPorte County Institute for Clinical Research
Michigan City, Indiana, United States, 46360
United States, Kentucky
L-MARC Research Center
Louisville, Kentucky, United States, 40213
United States, Louisiana
Horizon Research Group of Opelousas
Eunice, Louisiana, United States, 70535
United States, Maryland
MD Medical Research
Oxon Hill, Maryland, United States, 20745
IRC Clinics, Inc
Towson, Maryland, United States, 21204
United States, Michigan
Endeavor Medical Research, PLC
Alpena, Michigan, United States, 49707
Associated Internal Medicine Specialists, P.C.
Battle Creek, Michigan, United States, 49015
United States, New Mexico
Albuquerque Clinical Trials
Albuquerque, New Mexico, United States, 87102
United States, North Carolina
PMG Research of Charlotte
Charlotte, North Carolina, United States, 28209
PharmQuest
Greensboro, North Carolina, United States, 27408
United States, Ohio
Clinical Inquest Center, Ltd.
Beavercreek, Ohio, United States, 45431
United States, Oklahoma
Infinity Research Group, LLC
Oklahoma City, Oklahoma, United States, 73103
United States, South Carolina
Southeastern Research Associates, Inc.
Taylors, South Carolina, United States, 29687
United States, Tennessee
HCCA Clinical Research Solution
Franklin, Tennessee, United States, 37067
Holston Medical Group
Kingsport, Tennessee, United States, 37660-3256
New Phase Research & Development
Knoxville, Tennessee, United States, 37923
United States, Texas
The University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390
Texas Center for Drug Development, Inc.
Houston, Texas, United States, 77081
Excel Clinical Research, LLC
Houston, Texas, United States, 77081
Humble Cardiology Associates
Humble, Texas, United States, 77338
Cetero Research
San Antonio, Texas, United States, 78229
Cetero Research
San Antonio, Texas, United States, 78237
United States, Utah
Jean Brown Research
Salt Lake City, Utah, United States, 84124
Highland Clinical Research
Salt Lake City, Utah, United States, 84124
Czech Republic
Interni oddeleni
Havirov, Moravskoslezsky kraj, Czech Republic, 736 01
Hungary
Drug Research Center
Balatonfüred, Hungary, 8230
Synexus Hungary Ltd
Budapest, Hungary, 1036
Markhot Ferenc Hospital
Eger, Hungary, 3300
Kanizsai Dorottya Hospital
Nagykanizsa, Hungary, 8800
Medifarma 98
Nyíregyháza, Hungary, 4400
Borbanya Praxis Kft., Outpatient Clinic
Nyíregyháza, Hungary, 4400
Malaysia
Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
Poland
NZOZ Centrum Badan Klinicznych
Wroclaw, Dolnoslaskie, Poland, 50-349
NZOZ Centrum Medyczne Szpital Sw. Rodziny
Lodz, Lodzkie, Poland, 90-302
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna
Lodz, Lodzkie, Poland, 90-242
NZOZ Polimedica
Zgierz, Lodzkie, Poland, 95-100
Centrum Badan Klinicznych PI-House Sp. z o.o.
Gdansk, Pomorskie, Poland, 80-546
LANDA - Specjalistyczne Gabinety Lekarskie
Krakow, Poland, 30-015
SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Łodzi, Oddział Kliniczny Diabetologii
Lodz, Poland, 90-153
NZOZ Centrum Badan Klinicznych Oswiecim
Oswięcim, Poland, 32-600
Romania
Spital Clinic Judetean de Urgenta Oradea Stationarul 1
Oradea, Jud Bihor, Romania, 410169
Consultmed SRL
Iasi, Jud. Iasi, Romania, 700547
CMI Morosanu V. Magdalena
Galati, Judetul Galati, Romania, 800371
Centru Medical Dr. Negrisanu
Timisoara, Judical Timis, Romania, 300456
Tehnomed Trading Srl
Bucharest, Romania, 020354
O.D. Medica Srl
Bucharest, Romania, 020725
Institutul National De Diabet, Nutritie Si Boli Metabolice "Prof. Dr. N.C. Paulescu"
Bucuresti, Romania, 020475
Institutul de Diabet, Nutritie si Boli Metabolice "Dr. N. C. Paulescu"
Bucuresti, Romania, 020042
CMI Mateescu S. Ana-Maria
Constanta, Romania, 900675
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati
Galati, Romania, 800578
Diabmed Dr. Popescu Alexandrina SRL
Ploiesti, Romania, 100163
Russian Federation
3rd Central Military Clinical Hospital named after A.A.Vishnevskogo
Arkhangelskoe, Russian Federation, 143420
GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF
Chita, Russian Federation, 672090
"Clinic of New Medical Technology" Company Limited
Dzerzhinskiy, Russian Federation, 140091
The Urals State Medical Academy
Ekaterinburg, Russian Federation, 620102
Kemerovo Regional Clinical Hospital
Kemerovo, Russian Federation, 650066
"Krasnoyarsk State Medical University n.a. Prof. V.F. Voyno-Yasenetsky
Krasnoyarsk, Russian Federation, 660062
Central Clinical Hospital of Russian Academy of Sciences
Moscow, Russian Federation, 117593
Medical Sanitary Unit of Minestry of Internal Affairs of Russia in Moscow
Moscow, Russian Federation, 127299
State Healthcare Institution of Moscow "Cardiologival Dispensary #2 of Management Department of South Administrative District"
Moscow, Russian Federation, 117556
City Clinical Hospital # 13 of Avtozavodsky District of Nizhniy Novgorod
Nizhniy Novgorod, Russian Federation, 603018
Scientific Research Institute of Physiology of Siberian Department RAMS
Novosibirsk, Russian Federation, 630117
Novosibirsk State Medical University
Novosibirsk, Russian Federation, 630087
City Hospital # 38 named after N A Semashko
Pushkin, Russian Federation, 196601
Rostov State Medical University
Rostov-on-Don, Russian Federation, 344022
Ryazan State Medical University
Ryazan, Russian Federation, 390005
Center "Diabetes", LLC
Samara, Russian Federation, 443067
Smolensk State Medical Academy, Sanatorium-Preventorium
Smolensk, Russian Federation, 214019
Saint-Petersburg City Outpatient Clinic#37
St. Petersburg, Russian Federation, 191119
Medinet, LLC
St. Petersburg, Russian Federation, 190000
Saint-Petersburg City Pokrovskaya Hospital
St. Petersburg, Russian Federation, 199106
Saint-Petersburg state budgetary healthcare institution "City Polyclinic #109"
St. Petersburg, Russian Federation, 192283
Krestovsky Island Medical Institute, LLC
St. Petersburg, Russian Federation, 197042
International Medical Center "SOGAZ", LLC
St. Petersburg, Russian Federation, 198168
St. Elizabeth City Hospital
St. Petersburg, Russian Federation, 195257
Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov
St. Petersburg, Russian Federation, 197341
North-Western State Medical Unversity n.a. I.I.Mechnikov
St. Petersburg, Russian Federation, 191015
ANO "Medical Centre "XXI century"
St. Petersburg, Russian Federation, 194354
Alexanders City Hospital
St. Petersburg, Russian Federation, 193312
Clinical Hospital #122 n.a. Sokolov of FMBA
St. Petersburg, Russian Federation, 194291
Military Medical Academy named after S.M. Kirov
St. Petersburg, Russian Federation, 191124
Tyumen State Medical Academy
Tyumen, Russian Federation, 625023
Voronezh Regional Clinical Hospital #1
Voronezh, Russian Federation, 394082
Yaroslavl Regional Clinical Hospital
Yaroslavl, Russian Federation, 150062
Clinical Hospital for Emergency Care named after N.V. Solovyov
Yaroslavl, Russian Federation, 150003
Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery
Yaroslavl, Russian Federation, 150023
City Hospital named after N.A.Semashko
Yaroslavl, Russian Federation, 150002
Serbia
Clinical Center of Serbia
Belgrade, Serbia, 11000
Zvezdara University Medical Center
Belgrade, Serbia, 11000
Clinical Center of Kragujevac
Kragujevac, Serbia, 34000
Slovakia
Metabolic Center of Dr. Katarina Raslova Ltd.
Bratislava, Bratislavsky kraj, Slovakia, 831 01
METABOLKLINIK s.r.o.
Bratislava, Bratislavsky kraj, Slovakia, 811 08
ARETEUS s.r.o., Diabetologicka ambulancia
Trebisov, Kosicky kraj, Slovakia, 07501
ENDIAMED s.r.o
Dolny Kubin, Zilinsky kraj, Slovakia, 02601
MediVet s.r.o.
Malacky, Slovakia, 901 01
South Africa
Newkwa Medical Centre
Newlands West, Durban, South Africa, 4037
Drs. Naiker and Naicker Inc.
Overport, Durban, South Africa, 4001
Centre for Diabetes and Endocrinology Suite 1
Durban, South Africa, 4091
Soweto Clinical Trial Centre
Johannesburg, South Africa, 1818
Centre fro Diabetes and Endocrinology (Pty) Ltd
Johannesburg, South Africa, 2198
Centre for Diabetes, Asthma and Allergy
Johannesburg, South Africa, 01829
Aliwal Shoal Medical & Clinical Trial Centre
Kwa Zulu Natal, South Africa, 4170
Paarl Research Centre
Paarl, Cape Town, South Africa, 7647
Helderberg Clinical Trials Centre
Somerset West, South Africa, 7130
Tiervlei Trial Centre
Western Cape, South Africa, 7530
Thailand
Chulalongkorn University
Patumwan, Bangkok, Thailand, 10330
Rajavithi Hospital
Bangkok, Thailand, 10400
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Songklanagarind Hospital
Songkla, Thailand, 90110
Ukraine
City Clinical Hospital#9, Dnipropetrovsk State Medical Academy
Dnipropetrovsk, Ukraine, 49023
Educational Scientific Medical Centre "University clinic" of Donetsk National Medical University n.a. M.Gorkiy
Donetsk, Ukraine, 83003
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
Kyiv, Ukraine, 04050
National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clinic # 2 of Shevchenkovsky District
Kyiv, Ukraine, 04050
V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine
Kyiv, Ukraine, 04114
Municipal Institution Lutsk City Clinical Hospital
Lutsk, Ukraine, 43024
Lviv Regional Endocrinology Dispensary
Lviv, Ukraine, 79010
Odessa State Medical University
Odesa, Ukraine, 65039
Zhytomyr Regional Clinical Hospital
Zhytomyr, Ukraine, 10002
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Patrick Yue, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01494987     History of Changes
Other Study ID Numbers: GS-US-259-0110
Study First Received: December 15, 2011
Results First Received: August 21, 2014
Last Updated: September 17, 2014
Health Authority: United States: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Serbia: Medicines and Medical Devices Agency
Slovakia: State Institute for Drug Control
South Africa: Medicines Control Council
Ukraine: Ministry of Health

Keywords provided by Gilead Sciences:
Type 2 Diabetes Mellitus

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Glimepiride
Ranolazine
Anti-Arrhythmia Agents
Cardiovascular Agents
Enzyme Inhibitors
Hypoglycemic Agents
Immunologic Factors
Immunosuppressive Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014