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

This study has been completed.
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
First received: December 15, 2011
Last updated: February 19, 2014
Last verified: February 2014

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 subjects 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, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM. Participants on a treatment regimen containing metformin, a sulfonylurea agent other than glimepiride, or at a dose of glimepiride ≥ 2 mg and < 4 mg will switch to glimepiride 4 mg daily prior to randomization to study drug.

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: 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 HbA1c at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]
  • Change from baseline in fasting serum glucose (FSG) at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Change from baseline in 2-hour postprandial serum glucose at Week 24 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

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
Participants will receive ranolazine plus glimepiride in addition to diet and exercise for up to 24 weeks.
Drug: Ranolazine
Ranolazine 500 mg tablet administered orally twice daily for 7 days, followed by ranolazine 1000 mg (2 × 500 mg tablets) twice daily for the duration of the study.
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 were instructed to continue the diet regimen prescribed by their physician.
Behavioral: Exercise
Participants were instructed to continue the exercise regimen prescribed by their physician.
Placebo Comparator: Placebo+glimepiride
Participants will receive placebo to match ranolazine plus glimepiride in addition to diet and exercise for up to 24 weeks.
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 were instructed to continue the diet regimen prescribed by their physician.
Behavioral: Exercise
Participants were instructed to continue the exercise regimen prescribed by their physician.


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

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 Period 1 (Day 14 + 2 days)
  • Fasting Serum C-peptide ≥ 0.8 ng/mL at Screening
  • FSG ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL(13.3 mmol/L) at Screening and at the end of Period 1 (Day 14 + 2 days): A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 120 mg/dL (6.7 mmolL) 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 Period 1

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 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) > 3x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3x ULN and/or serum total bilirubin > 2.0 mg/dL
  • History of cancer (except non-melanomic 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 subject, 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01494987

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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
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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
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PAB Clinical Research
Brandon, Florida, United States, 33511
Florida Research Network, LLC
Gainesville, Florida, United States, 32605-4253
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Miami Beach, Florida, United States, 33140
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St. Petersburg, Florida, United States, 33716
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Winter Haven, Florida, United States, 33880
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Synergy Therapeutic Partners
Atlanta, Georgia, United States, 30127
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CTL Research
Eagle, Idaho, United States, 83616
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Cedar-Crosse Research Center
Chicago, Illinois, United States, 60607
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LaPorte County Institute for Clinical Research
Michigan City, Indiana, United States, 46360
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L-MARC Research Center
Louisville, Kentucky, United States, 40213
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Horizon Research Group of Opelousas
Eunice, Louisiana, United States, 70535
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Towson, Maryland, United States, 21204
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Alpena, Michigan, United States, 49707
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Clinical Inquest Center, Ltd.
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Infinity Research Group, LLC
Oklahoma City, Oklahoma, United States, 73103
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Taylors, South Carolina, United States, 29687
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HCCA Clinical Research Solution
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Holston Medical Group
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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
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Interni oddeleni
Havirov, Moravskoslezsky kraj, Czech Republic, 736 01
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
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Borbanya Praxis Kft., Outpatient Clinic
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Hospital Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia, 16150
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Wroclaw, Dolnoslaskie, Poland, 50-349
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Lodz, Lodzkie, Poland, 90-302
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Zgierz, Lodzkie, Poland, 95-100
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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
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
O.D. Medica Srl
Bucharest, Romania, 020725
Tehnomed Trading Srl
Bucharest, Romania, 020354
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
Medical Sanitary Unit of Minestry of Internal Affairs of Russia in Moscow
Moscow, Russian Federation, 127299
Central Clinical Hospital of Russian Academy of Sciences
Moscow, Russian Federation, 117593
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
ANO "Medical Centre "XXI century"
St. Petersburg, Russian Federation, 194354
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
Clinical Hospital #122 n.a. Sokolov of FMBA
St. Petersburg, Russian Federation, 194291
Saint-Petersburg City Pokrovskaya Hospital
St. Petersburg, Russian Federation, 199106
Military Medical Academy named after S.M. Kirov
St. Petersburg, Russian Federation, 191124
Saint-Petersburg state budgetary healthcare institution "City Polyclinic #109"
St. Petersburg, Russian Federation, 192283
St. Elizabeth City Hospital
St. Petersburg, Russian Federation, 195257
Saint-Petersburg City Outpatient Clinic#37
St. Petersburg, Russian Federation, 191119
International Medical Center "SOGAZ", LLC
St. Petersburg, Russian Federation, 198168
Medinet, LLC
St. Petersburg, Russian Federation, 190000
Alexanders City Hospital
St. Petersburg, Russian Federation, 193312
Krestovsky Island Medical Institute, LLC
St. Petersburg, Russian Federation, 197042
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
Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery
Yaroslavl, Russian Federation, 150023
Clinical Hospital for Emergency Care named after N.V. Solovyov
Yaroslavl, Russian Federation, 150003
City Hospital named after N.A.Semashko
Yaroslavl, Russian Federation, 150002
Zvezdara University Medical Center
Belgrade, Serbia, 11000
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Center of Kragujevac
Kragujevac, Serbia, 34000
Metabolic Center of Dr. Katarina Raslova Ltd.
Bratislava, Bratislavsky kraj, Slovakia, 831 01
Bratislava, Bratislavsky kraj, Slovakia, 811 08
ARETEUS s.r.o., Diabetologicka ambulancia
Trebisov, Kosicky kraj, Slovakia, 07501
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
Centre for Diabetes, Asthma and Allergy
Johannesburg, South Africa, 01829
Centre fro Diabetes and Endocrinology (Pty) Ltd
Johannesburg, South Africa, 2198
Soweto Clinical Trial Centre
Johannesburg, South Africa, 1818
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
Chulalongkorn University
Patumwan, Bangkok, Thailand, 10330
Phramongkutklao Hospital
Bangkok, Thailand, 10400
Rajavithi Hospital
Bangkok, Thailand, 10400
Songklanagarind Hospital
Songkla, Thailand, 90110
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
  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
Last Updated: February 19, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Hungary: Institutional Ethics Committee
Hungary: National Institute of Pharmacy
Malaysia: Institutional Review Board
Malaysia: Ministry of Health
Poland: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Serbia: Ethics Committee
Slovakia: State Institute for Drug Control
Slovakia: Ethics Committee
South Africa: Human Research Ethics Committee
South Africa: Medicines Control Council
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Ukraine: Ethics Committee
Ukraine: Ministry of Health

Keywords provided by Gilead Sciences:
Type 2 Diabetes Mellitus

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

ClinicalTrials.gov processed this record on August 21, 2014