Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01472185
Recruitment Status : Completed
First Posted : November 16, 2011
Results First Posted : October 15, 2014
Last Update Posted : October 24, 2014
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, multi-center study to determine the effect of ranolazine when given as monotherapy on glycemic control in subjects with type 2 diabetes mellitus (T2DM) who were inadequately controlled with diet and exercise alone and who are treatment naive to antihyperglycemic therapy or have not received antihyperglycemic therapy in the 90 days (or thiazolidinediones [TZDs] for at least 24 weeks) prior to screening, and to characterize the relationship between HbA1c reduction and other glycemic parameters in subjects with T2DM.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Drug: Ranolazine Drug: Placebo Behavioral: Diet Behavioral: Exercise Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 465 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Ranolazine Monotherapy in Subjects With Type 2 Diabetes Mellitus
Study Start Date : November 2011
Actual Primary Completion Date : October 2013
Actual Study Completion Date : October 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Ranolazine

Arm Intervention/treatment
Placebo Comparator: Placebo

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Placebo to match ranolazine (Days 1-7: 1 tablet twice daily; 2 tablets twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.

Drug: Placebo
Placebo to match ranolazine administered orally twice 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.

Experimental: Ranolazine

Qualifying Period: Placebo to match ranolazine (1 tablet twice daily) for 14 days.

Treatment Period: Ranolazine tablets (Days 1-7: 1 × 500 mg twice daily; 2 × 500 mg twice daily thereafter) for up to 24 weeks.

Participants were required to maintain their diet and exercise regimen.

Drug: Ranolazine
Ranolazine tablets administered orally twice daily.
Other Name: Ranexa®

Drug: Placebo
Placebo to match ranolazine administered orally twice 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.

Primary Outcome Measures :
  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 [ Time Frame: Baseline; Week 24 ]
    The average (mean) change from baseline in HbA1c at Week 24 was analyzed.

Secondary Outcome Measures :
  1. Change From Baseline in Fasting Serum Glucose at Week 24 [ Time Frame: Baseline; Week 24 ]
    The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.

  2. Percentage of Participants With HbA1c < 7% at Week 24 [ Time Frame: Week 24 ]
  3. Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24 [ Time Frame: Baseline; Week 24 ]

    The average (mean) change from baseline in 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 time [T] = 120 minutes during the MMTT, administered under fasting conditions, excluding participants with major eligibility protocol violations and analyzed based on the randomized treatment regardless of actual treatment received.

  4. Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24 [ Time Frame: Baseline; Week 24 ]
    The average (mean) change from baseline in incremental change of 2-hour postprandial serum glucose at Week 24 was analyzed.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Written informed consent
  • Males and females, 18 to 75 years old, inclusive
  • Documented history of T2DM
  • Treatment naïve to antihyperglycemic therapy or having received no prior treatment with antihyperglycemic therapy for at least 90 days (TZDs for at least 24 weeks) prior to screening
  • Body mass index (BMI) 25 kg/m2 to 45 kg/m2 inclusive at screening
  • HbA1c 7% - 10%, inclusive at screening and at the end of the Qualifying Period (Day 14 +2 days)
  • Fasting serum glucose (FSG) of ≥ 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 +2 days). A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 125 mg/dL (6.9 mmol/L) and < 130 mg/dL (7.2 mmol/L) who are otherwise eligible as determined by the investigator.
  • Fasting serum C-peptide ≥ 0.8 ng/mL at screening
  • Able and willing to comply with all study procedures during the course of the study
  • Females of child-bearing potential must have a negative 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 with 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 or cerebrovascular event (eg, myocardial infarction [MI], acute coronary syndrome [ACS], recent coronary 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 systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at screening and randomization
  • Prolonged QTc interval > 500 msec by 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 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 on a weight-loss program and is not in the 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
  • Prior treatment with open-label ranolazine or known hypersensitivity or intolerance to ranolazine or any of its excipients
  • Treatment with strong or moderate cytochrome (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, sirolimus) within 14 days prior to randomization
  • Treatment with simvastatin at a daily dose > 20 mg or lovastatin at a daily dose > 40 mg, within 14 days prior to randomization
  • Weight-loss medication or anti-obesity medication (prescription or nonprescription) < 3 months prior to screening
  • Treatment with niacin > 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 90 days prior to screening and for the duration of the study
  • 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 antihyperglycemic therapy < 90 days prior to screening
  • Donation of blood < 2 months prior to screening; plans to donate blood while participating in the study
  • Females who are pregnant or breastfeeding
  • Other condition(s) that, in the opinion of the investigator, would compromise the safety of the subject, would prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or would compromise the quality of the clinical study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01472185

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United States, Arizona
Thunderbird Internal Medicine/Clinical Research Advantage
Glendale, Arizona, United States, 85306
Central Phoenix Medical Clinic
Phoenix, Arizona, United States, 85020
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Tucson, Arizona, United States, 85710
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Boca Raton, Florida, United States, 33432
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Miami Beach, Florida, United States, 33140
Precision Research Organization
Miami Lakes, Florida, United States, 33016
Baptist Diabetes Associates
Miami, Florida, United States, 33156
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Orlando, Florida, United States, 32822
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Atlanta, Georgia, United States, 30127
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Eagle, Idaho, United States, 83616
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Dallas, Texas, United States, 75390
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Budapest, Hungary, 1036
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Eger, Hungary, 3300
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Nyíregyháza, Hungary, 4400
Medifarma 98
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Zala County Hospital
Zalaegerszeg, Hungary, 08900
NZOZ Regionalna Poradnia Diabetologiczna
Wroclaw, Dolnoslaskie, Poland, 50-127
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Wroclaw, Dolnoslaskie, Poland, 50-349
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Lodz, Lodzkie, Poland, 90-153
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Lodz, Poland, 92-003
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Ostroda, Poland, 14-100
Miedzyleski Szpital Specjalistyczny w Warszawie
Warszawa, Poland, 04-749
Spital Clinic Judetean de Urgenta Oradea Stationarul 1
Oradea, Jud Bihor, Romania, 410169
Vitadiab SRL - Cabinet Medical Dr. Barabas Alina SRL
Brasov, Jud Brasov, Romania, 500269
Consultmed SRL
Iasi, Jud. Iasi, Romania, 700547
CMI Diabet Nutritie Boli Metabolice Dr. Pop Lavinia
Baia Mare, Jud. Maramures, Romania, 430123
CMI Morosanu V. Magdalena
Galati, Judetul Galati, Romania, 800371
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Galati
Galati, Judetul Galati, Romania, 800578
Diabmed Dr. Popescu Alexandrina SRL
Ploiesti, Judetul Prahova, Romania, 100163
Tehnomed Trading Srl
Bucharest, Romania, 020354
Institutul de Diabet, Nutritie si Boli Metabolice "Dr. N. C. Paulescu"
Bucuresti, Romania, 020042
O.D. Medica Srl
Bucuresti, Romania, 020725
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Timisoara, jud. Timis, Romania, 300456
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3rd Central Military Clinical Hospital named after A.A.Vishnevskogo
Arkhangelskoe, Russian Federation, 143420
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Chita, Russian Federation, 672090
"Clinic of New Medical Technology" Company Limited
Dzerzhinskiy, Russian Federation, 140091
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Ekaterinburg, Russian Federation, 620102
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Kemerovo, Russian Federation, 650066
"Krasnoyarsk State Medical University n.a. Prof. V.F. Voyno-Yasenetsky
Krasnoyarsk, Russian Federation, 660062
State Healthcare Institution of Moscow "Cardiologival Dispensary #2 of Management Department of South Administrative District"
Moscow, Russian Federation, 117556
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
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Moscow, Russian Federation, 129090
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Nizhniy Novgorod, Russian Federation, 603018
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Novosibirsk, Russian Federation, 630087
LLC "Reafan"
Novosibirsk, Russian Federation, 630099
Scientific Research Institute of Physiology of Siberian Department RAMS
Novosibirsk, Russian Federation, 630117
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, +011 78123152068
Medinet, LLC
St. Petersburg, Russian Federation, 190000
North-Western State Medical Unversity n.a. I.I.Mechnikov
St. Petersburg, Russian Federation, 191015
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
Alexanders City Hospital
St. Petersburg, Russian Federation, 193312
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St. Petersburg, Russian Federation, 194291
ANO "Medical Centre "XXI century"
St. Petersburg, Russian Federation, 194354
St. Elizabeth City Hospital
St. Petersburg, Russian Federation, 195257
Krestovsky Island Medical Institute, LLC
St. Petersburg, Russian Federation, 197042
Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov
St. Petersburg, Russian Federation, 197341
Military Medical Academy named after S.M. Kirov
St. Petersburg, Russian Federation, 198013
International Medical Center "SOGAZ", LLC
St. Petersburg, Russian Federation, 198168
Saint-Petersburg City Pokrovskaya Hospital
St. Petersburg, Russian Federation, 199106
Tyumen State Medical Academy
Tyumen, Russian Federation, 625023
Voronezh Regional Clinical Hospital #1
Voronezh, Russian Federation, 394082
City Hospital named after N.A.Semashko
Yaroslavl, Russian Federation, 150002
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
Yaroslavl Regional Clinical Hospital
Yaroslavl, Russian Federation, 150062
Clinical Center of Serbia
Belgrade, Serbia, 11000
Clinical Center of Kragujevac
Kragujevac, Serbia, 34000
Bratislava, Bratislavsky kraj, Slovakia, 811 01
Metabolic Center of Dr. Katarina Raslova Ltd.
Bratislava, Bratislavsky kraj, Slovakia, 831 01
"Diabetologicka a metabolicka ambulancia Human-care s.r.o"
Kosice, Kosicky kraj, Slovakia, 04001
ARETEUS s.r.o., Diabetologicka ambulancia
Trebisov, Kosicky kraj, Slovakia, 07501
Dolny Kubin, Zilinsky kraj, Slovakia, 02601
Zilina, Zilinsky kraj, Slovakia, 010 10
MediVet s.r.o.
Malacky, Slovakia, 901 01
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Newkwa Medical Centre
Newlands West, Durban, South Africa, 4037
Netcare Umhlanga Medical Centre
Kwa Zulu Natal, Umhlanga, Durban, South Africa, 4320
Worthwhile Clinical Trials
Benoni, South Africa, 1500
Centre for Diabetes, Asthma and Allergy
Johannesburg, South Africa, 01829
Soweto Clinical Trial Centre
Johannesburg, South Africa, 1818
Aliwal Shoal Medical & Clinical Trial Centre
Kwa Zulu Natal, South Africa, 4170
Global Clinical Trials
Pretoria, South Africa, 0001
Helderberg Clinical Trials Centre
Somerset West, South Africa, 7130
Tiervlei Trial Centre
Western Cape, South Africa, 7530
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
State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukraine"
Kharkiv, Ukraine, 61002
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
Public Institution "City Outpatients' Hospital #20"
Odesa, Ukraine, 65114
Vinnytsya Regional Clinical Endocrinology Dispensary
Vinnytsya, Ukraine, 21010
Zhytomyr Regional Clinical Hospital
Zhytomyr, Ukraine, 10002
Sponsors and Collaborators
Gilead Sciences

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Gilead Sciences Identifier: NCT01472185     History of Changes
Other Study ID Numbers: GS-US-259-0131
First Posted: November 16, 2011    Key Record Dates
Results First Posted: October 15, 2014
Last Update Posted: October 24, 2014
Last Verified: October 2014

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
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action