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Type 2 Diabetes MellitusPhase 3NCT01555164

A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone

A Phase 3 study testing Ranolazine, Metformin and Diet in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 146 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
Ranolazine, Metformin and Diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
442 participants
Where
146 sitesin 11 countries
Study dates
Jun 2012to Oct 2013
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented history of T2DM
  • Metformin therapy at a stable total daily dose ≥ 1500 mg and ≤ 2550 mg in addition to diet and exercise for ≥ 8 weeks prior to Screening
  • Body mass index (BMI) 25 to 45 kg/m^2, inclusive, at Screening
  • HbA1c within specified ranges at Screening and at the end of the Qualifying Period based on current metformin dose
  • 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

Who cannot join

  • Type 1 diabetes mellitus
  • History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
  • History of severe hypoglycemia
  • Any clinically significant cardiovascular or cerebrovascular event ≤ 3 months prior to Screening
  • History of congestive heart failure
  • Corrected QT interval (QTc) > 500 msec by ECG at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or individuals who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
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  • Serum creatinine concentration ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females at Screening
  • 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
  • Use of any non-insulin antihyperglycemic therapy (other than metformin) for more than 14 days (consecutive or not) during the 12 weeks (24 weeks for thiazolidinediones) prior to Screening and/or use of any antihyperglycemic therapy other than metformin, at any dose, at any time during the 4 weeks prior to randomization
  • Treatment with chronic insulin within 24 weeks prior to Screening (except for one temporary period of daily insulin injections no longer than 7 days)
  • Treatment with strong or moderate cytochrome P450 3A (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 simvastatin or lovastatin at a dose > 20 mg or > 40 mg daily, respectively, within 14 days prior to randomization

Trial locations and contacts

146 sites in 11 countries.

146 sites in 11 countries

United States60 sites

  • Albuquerque Clinical Trials, Inc.

    Albuquerque, New Mexico, 87102

  • University of New Mexico Health Sciences Center

    Albuquerque, New Mexico, 87131-0001

  • Alexandria Cardiology Clinic

    Alexandria, Louisiana, 71301

  • Blair Medical Associates Inc.

    Altoona, Pennsylvania, 16602

  • Synergy Therapeutic Partners

    Atlanta, Georgia, 30312

  • Perimeter Institute for Clinical Research

    Atlanta, Georgia, 30338

  • Bellevue Family Practice

    Bellevue, Nebraska, 68005

  • Boca Raton Clinical Research Associates, Inc.

    Boca Raton, Florida, 33432

  • Advanced Clinical Research

    Boise, Idaho, 83642

  • Progressive Clinical Research, LLC

    Bountiful, Utah, 84010

  • Holston Medical Group, P.C.

    Bristol, Tennessee, 37620

  • Burke Internal Medicine, Inc.

    Burke, Virginia, 22015

  • Radiant Research, Inc.

    Chandler, Arizona, 85224

  • Pharmacorp Clinical Trials, Inc.

    Charleston, South Carolina, 29412

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • Rapid Medical Research, Inc

    Cleveland, Ohio, 44122

  • Colorado Springs Health Partners

    Colorado Springs, Colorado, 80906

  • Columbus Research Foundation

    Columbus, Georgia, 31904

  • Columbus Clinical Research Inc.

    Columbus, Ohio, 43213

  • Study site

    Corpus Christi, Texas, 78414

  • Dallas Diabetes and Endocrine Center

    Dallas, Texas, 75230

  • Hometown Urgent Care and Research

    Dayton, Ohio, 45432

  • Choose To Lose

    Eagle, Idaho, 83616

  • Safe Harbor Clinical Research

    East Providence, Rhode Island, 02914

  • Lillestol Research

    Fargo, North Dakota, 58103

  • PhysiqueMed Clinical Trials

    Greensboro, North Carolina, 27405

  • DeGarmo Institute of Medical Research

    Greer, South Carolina, 29651

  • Fundamental Research LLC

    Gulf Shores, Alabama, 36542

  • MD Clinical Institute

    Hallandale, Florida, 33009

  • Clinical Research Advantage

    Henderson, Nevada, 89052

  • A G A Clinical Trials

    Hialeah, Florida, 33012

  • Clinical Trials of America Inc

    Hickory, North Carolina, 28601

  • West Houston Clinical Research

    Houston, Texas, 77055

  • Juno Research, LLC

    Houston, Texas, 77074

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • University Medical Associates

    Huntersville, North Carolina, 28078

  • Juno Research, LLC

    Katy, Texas, 77450

  • New Phase Research & Development

    Knoxville, Tennessee, 37923

  • Northstate Clinical Research

    Lenoir, North Carolina, 28645

  • KLR Business Group DBA Arkansas Clinical Research

    Little Rock, Alaska, 72205

  • National Research Institute

    Los Angeles, California, 90057

  • Manassas Clinical Research Center

    Manassas, Virginia, 20110

  • Covington Medical Care

    Mandeville, Louisiana, 70471

  • Clinical Trials Management, LLC

    Metairie, Louisiana, 70006

  • Baptist Diabetes Associates

    Miami, Florida, 33156

  • Florida Institute for Clinical Research LLC

    Orlando, Florida, 32822

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Central Phoenix Medical Clinic

    Phoenix, Arizona, 85020

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Ritchken and First MD's

    San Diego, California, 92117

  • Medical Research Group of Central Florida

    Sanford, Florida, 32771

  • Clearview Medical Research, LLC

    Santa Clarita, California, 91350

  • Northeast Clinical Research of San Antonio, LLC

    Schertz, Texas, 78154

  • Carolina Research Center

    Shelby, North Carolina, 28150

  • Study site

    Sugarland, Texas, 77479

  • Metabolic Institute of America

    Tarzana, California, 91356

  • Clinical Research Advantage

    Tempe, Arizona, 85282

  • Desert Sun Clinical Research, LLC

    Tucson, Arizona, 85710

  • University Clinical Investigators

    Tustin, California, 92780

  • Infosphere Clinical Research

    West Hills, California, 91307

Other trials in United States

Russia25 sites

  • GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF

    Chita, 672090

  • Clinic of New Medical Technology Company Limited

    Dzerzhinskiy, 140091

  • Kemerovo Regional Clinical Hospital

    Kemerovo, 650066

  • State Institution of Public Health of Moscow City Endocrinology Dispensary

    Moscow, 119034

  • Novosibirsk State Medical University

    Novosibirsk, 630087

  • Reafan, LLC

    Novosibirsk, 630099

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Ryazan State Medical University

    Ryazan, 29005

  • Medinet, LLC

    Saint Petersburg, 190000

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

    Saint Petersburg, 191015

  • Saint-Petersburg City Outpatient Clinic#37

    Saint Petersburg, 191119

  • Military Medical Academy named after S.M. Kirov

    Saint Petersburg, 191124

  • City Diabetology Center #4, "City Polyclinic #77"

    Saint Petersburg, 192012

  • Alexanders City Hospital

    Saint Petersburg, 193312

  • Clinical Hospital #122 n.a. Sokolov of FMBA

    Saint Petersburg, 194291

  • ANO Medical Centre XXI Century

    Saint Petersburg, 194354

  • City Hospital #38 named after N. A. Semashko

    Saint Petersburg, 196601

  • Krestovsky Island Medical Institute, LLC

    Saint Petersburg, 197042

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

    Saint Petersburg, 197341

  • Federal State Budget Military Educational Institution Medical Military Academy n. a. S. M. Kirov

    Saint Petersburg, 198013

  • SPb GBUZ Diagnostic Center #85

    Saint Petersburg, 198255

  • Center "Diabetes", LLC

    Samara, 443067

  • Smolensk State Medical Academy, Sanatorium-Preventorium

    Smolensk, 214019

  • City Hospital named after N.A.Semashko

    Yaroslavl, 150002

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, 150062

Other trials in Russia

India22 sites

  • DHL Research Centre, 2nd Floor

    Ahmedabad, Gujarat, 380015

  • Dia Care- A Complete Diabetes Care Center

    Ahmedabad, Gujarat, 380015

  • Endocrinology & Diabetes Research Centre

    Bangalore, Karnataka, 560003

  • Manipal Hospital

    Bangalore, Karnataka, 560017

  • Endocrinology Diabetes Centre

    Bangalore, Karnataka, 560038

  • Bangalore Diabetes Hospital

    Bangalore, Karnataka, 560043

  • The Bangalore Diabetes Hospital

    Bangalore, Karnataka, 560052

  • Jnana Sanjeevani Medical Center

    Bangalore, Karnataka, 560078

  • Fortis City Centre

    Chandigarh, Punjab, 160017

  • Swamy Diabetes Centre

    Chennai, Tamil Nadu, 600028

  • Madras Diabetes Research Foundation

    Chennai, Tamil Nadu, 600086

  • Kovai Diabetes Speciality Centre & Hospital

    Coimbatore, Tamil Nadu, 641009

  • Diabetomics India

    Hyderabad, Andhra Pradesh, 500034

  • Diabetes and Heart Centre

    Ludhiana, Punjab, 141008

  • Vinaya Hospital and Research Centre

    Mangalore, Karnataka, 575003

  • Seth G. S. Medical College and KEM Hospital

    Mumbai, Maharashtra, 400012

  • Institue of Clinical Endocrinology (I.C.E) and Diabetes Care Unit (D.C.U),

    Nagpur, Maharashtra, 440010

  • Getwell Hospital and Research Institute

    Nagpur, Maharashtra, 440012

  • Diabetes Care and Research Centre

    Pune, Maharashtra, 411011

  • KEM Hospital Research Center

    Pune, Maharashtra, 411011

  • Baroda Medical College and SSG Hospital

    Vadodara, Gujarat, 390001

  • Banker's Heart Institute

    Vadodara, Gujarat, 390015

Other trials in India

South Africa10 sites

  • East Rand Research Trading as Worthwhile Clinical Trials

    Benoni, 1500

  • Charlotte Maxeke Johannesburg Academic Hospital

    Johannesburg, 2193

  • Vawda Z Private Practice

    Kwa Zulu Natal, Durban, 4091

  • Aliwal Shoal Medical & Clinical Trial Centre

    Kwa Zulu Natal, 4170

  • Netcare Umhlanga Medical Centre

    Kwa Zulu Natal, 4320

  • Centre for Diabetes and Endocrinology Suite 1

    KwaKhangela, Durban, 4091

  • Synexus Clinical Research SA (Pty) Ltd

    Meyerspark, Pretoria, 0102

  • Newkwa Medical Centre

    Newlands West, Durban, 4037

  • Drs. Naiker and Naicker Inc.

    Overport, Durban, 4001

  • Helderberg Clinical Trials Centre

    Somerset West, 7129

Other trials in South Africa

Ukraine10 sites

  • Educational Scientific Medical Centre, Donetsk National Medical University

    Donetsk, 83003

  • State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukra

    Kharkiv, 61002

  • Ukrainian Scientific-and-Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs

    Kyiv, 02175

  • Department of Endocrinology of Railway Clinical Hospital #2 of station "Kyiv" of South East Railroad

    Kyiv, 03049

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

    Kyiv, 04050

  • National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clini

    Kyiv, 04050

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

    Kyiv, 04114

  • Odessa State Medical University

    Odesa, 65039

  • Odessa City Policlinic #20

    Odesa, 65114

  • Vinnytsya Regional Clinical Endocrinology Dispensary

    Vinnytsia, 21010

Other trials in Ukraine

Hungary5 sites

  • Synexus Hungary Ltd

    Budapest, 1036

  • Selye János Kórház és Rendel?intézet, Belgyógyászati Szakrendelés

    Komárom, 2900

  • Kanizsai Dorottya Hospital

    Nagykanizsa, 8800

  • Medifarma 98

    Nyíregyháza, 4400

  • Borbanya Praxis Kft., Outpatient Clinic

    Nyíregyháza, 4405

Other trials in Hungary

Canada4 sites

  • Joanne F. Liutkus Medicine Professional Corporation

    Cambridge, Ontario, N1R7L6

  • Source Unique Research

    Hawkesbury, Ontario, K6A 1A1

  • The Medical Arts Health Research Group

    Kelowna, British Columbia, V1Y 3G8

  • Diabetes Research Clinic

    Vancouver, British Columbia, V5Z 1L8

Other trials in Canada

Poland4 sites

  • Niepubliczy Zaklad Opieki Zdrowotnej (NZOZ) Specjalistyczny Osrodek Internistyczno - Diabetologiczny

    Bialystok, 15-435

  • NZOZ "Esculap" S.C.

    Gniewkowo, 88-140

  • LANDA - Specjalistyczne Gabinety Lekarskie

    Krakow, Lesser Poland Voivodeship, 30-015

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

    Lodz, Łódź Voivodeship, 90242

Other trials in Poland

Israel3 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • Edith Wolfson Medical Center

    Holon, 58100

  • Ziv Medical Center Safed-Israel

    Safed, 13100

Other trials in Israel

Czechia2 sites

  • Nemocnice s poliklinikou Havirov

    Havířov, Moravian-Silesian Region, 736-01

  • Restrial s.r.o.

    Prague, Prague, 18100

Other trials in Czechia

Mexico1 site

  • Instituto Jalisciense de Investigación en Diabetes y Obesidad

    Guadalajara, Jalisco, 44600

Other trials in Mexico

About this study

Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Ranolazine When Added to Metformin in Subjects With Type 2 Diabetes Mellitus

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

Being tested
Ranolazine, Placebo to match ranolazine, Metformin, Placebo to match metformin, Diet
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RanolazineDrug

    Also called Ranexa®

    Ranolazine tablet(s) administered orally

  • Placebo to match ranolazineDrug

    Placebo to match ranolazine for the duration of the study

  • MetforminDrug

    Metformin tablet(s) administered orally once daily

  • Placebo to match metforminDrug

    Placebo to match metformin for the duration of the study

  • DietBehavioural

    Participants are instructed to continue the diet regimen prescribed by their physician.

  • ExerciseBehavioural

    Participants are instructed to continue the exercise regimen prescribed by their physician.

Study groups in NCT01555164
Study groupRoleWhat they receive
Ranolazine+metforminExperimentalQualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening). Treatment Period: Participants will receive ranolazine 500 mg + metformin 500 mg + placebo to match metformin twice daily on Days 1 through 7, followed by ranolazine 1000 mg + metformin 500 mg + placebo to match metformin twice daily from Day 8 through Week 24. Participants are required to maintain their diet and exercise regimen.
Receives: Drug: Ranolazine; Drug: Metformin; Drug: Placebo to match metformin; Behavioral: Diet; Behavioral: Exercise
Placebo+metforminPlacebo comparatorQualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening). Treatment Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily through Week 24. Participants are required to maintain their diet and exercise regimen.
Receives: Drug: Placebo to match ranolazine; Drug: Metformin; Behavioral: Diet; Behavioral: Exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24

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

    Measured: Baseline; Week 24

Secondary outcomes (2)

  1. Change From Baseline in Fasting Serum Glucose at Week 24

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

    Measured: Baseline; Week 24

  2. Change From Baseline in 2-hour Postprandial Serum Glucose at 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 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.

    Measured: Baseline; Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Mar 2012 (estimated)
  2. Study startJun 2012
  3. Primary completionSep 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
442 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01555164
Sponsor's protocol ID
GS-US-259-0147
Other IDs
2012-001259-37
Status last verified
Sep 2014
First submitted
13 Mar 2012
Last updated
23 Sep 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranolazine, Metformin and Diet in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 146 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 146 sites in United States, Russia, India, South Africa, Ukraine and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Sep 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24 (time frame: Baseline; Week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01555164.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2014; AzTrials last refreshed its copy on 6 Nov 2026.

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