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Type 2 Diabetes MellitusPhase 3NCT01494987

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

A Phase 3 study testing Ranolazine, Glimepiride and Diet in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 140 sites in 12 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, 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… 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, Glimepiride and Diet
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
431 participants
Where
140 sitesin 12 countries
Study dates
Jan 2012to Aug 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

  • 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:
  • glimepiride at a daily dose of ≥ 2 mg and ≤ 4 mg
  • glipizide, glyburide, or glibenclamide (or equivalent) at a daily dose of ≥ 7.5 mg
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  • gliclazide at a daily dose of > 160 mg (or ≥ 60 mg for the modified release [MR] formulation)
  • 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

Who cannot join

  • 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
Show all 32Show fewer
  • Prolonged QT interval corrected for heart rate (QTc) interval > 500 msec by electrocardiogram (ECG) at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
  • History of bariatric surgery at any time in the past or or any other surgery < 2 months before Screening; or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the medical monitor.
  • Any other hospitalization in the 14 days prior to Screening or planned hospitalization at any time during the study
  • Significant weight change (± 5%) < 2 months prior to Screening or enrollment in a weight-loss program other than a maintenance phase at Screening.
  • Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation < 30 mL/min/1.73 m2 at Screening or undergoing any type of dialysis at Screening or planning to undergo any type of dialysis during the course of the study
  • History of liver cirrhosis (Child-Pugh Class A, B or C)
  • Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL
  • History of cancer (except nonmelanomic skin cancers or cervical in situ) within 5 years prior to Screening
  • History of alcohol or other drug abuse < 12 months prior to Screening
  • Any other clinically significant existing medical or psychiatric condition, including clinically significant laboratory abnormalities, or one requiring further evaluation that in the opinion of the investigator could interfere with conduct of the study or interpretation of the data
  • Use of antihyperglycemic agents other than sulfonylurea agents or metformin, including but not limited to dipeptidyl peptidase-4 inhibitors (eg, saxagliptin and sitagliptin), glucagon-like peptide-mimetics (eg, exenatide), or insulin < 3 months prior to Screening; use of thiazolidinediones (TZDs) (eg, rosiglitazone or pioglitazone) < 24 weeks prior to Screening
  • Previous history of intolerance of glimepiride (as a single-agent therapy)
  • Prior treatment with open-label ranolazine, or known hypersensitivity or intolerance to ranolazine or any of its excipients
  • Treatment with strong or moderate cytochrome P (CYP)3A inhibitors or P-glycoprotein (P-gp) inhibitors within 14 days prior to randomization
  • Treatment with CYP3A inducers or P-gp inducers within 14 days prior to randomization
  • Treatment with CYP3A4 substrates with a narrow therapeutic range (eg, cyclosporine, tacrolimus, or sirolimus) within 14 days prior to Randomization
  • Treatment with simvastatin at a dose of > 20 mg daily or lovastatin at a dose of > 40 mg daily within 14 days prior to Randomization
  • Weight loss medication or anti-obesity medication (prescription or non-prescription) < 3 months prior to Screening
  • Treatment with niacin > 200 mg daily; if receiving ≤ 200 mg daily, should be on stable doses for ≥ 3 months prior to Screening
  • Expected or current treatment with systemic corticosteroids (oral or injectable) for > 14 days from Screening through the end of the Treatment Period. Topical or inhaled corticosteroid formulations are permitted at any time during the study.
  • If receiving thyroid replacement therapy, should be on stable doses for at least 6 weeks prior to randomization
  • Hemoglobin < 12 g/dL for males or < 11 g/dL for females at Screening
  • Participation in another clinical study involving an investigational drug or device < 30 days prior to Screening; participation in another clinical study involving an oral antihyperglycemic agent (OHA) < 90 days prior to Screening
  • Donation of blood < 2 months prior to Screening or plans to donate blood while participating in the study
  • Females who are pregnant or are breastfeeding
  • Other condition(s) that, in the opinion of the investigator, would compromise the safety of the individual, prevent compliance with the study protocol (including the ability to comply with Mixed Meal Tolerance Test [MMTT]), or compromise the quality of the clinical study

Trial locations and contacts

140 sites in 12 countries.

140 sites in 12 countries

United States46 sites

  • Albuquerque Clinical Trials

    Albuquerque, New Mexico, 87102

  • Endeavor Medical Research, PLC

    Alpena, Michigan, 49707

  • Synergy Therapeutic Partners

    Atlanta, Georgia, 30127

  • Associated Internal Medicine Specialists, P.C.

    Battle Creek, Michigan, 49015

  • Clinical Inquest Center, Ltd.

    Beavercreek, Ohio, 45431

  • PAB Clinical Research

    Brandon, Florida, 33511

  • PMG Research of Charlotte

    Charlotte, North Carolina, 28209

  • Cedar-Crosse Research Center

    Chicago, Illinois, 60607

  • The University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • CTL Research

    Eagle, Idaho, 83616

  • Horizon Research Group of Opelousas

    Eunice, Louisiana, 70535

  • Southland Clinical Research Center, Inc.

    Fountain Valley, California, 92708

  • HCCA Clinical Research Solution

    Franklin, Tennessee, 37067

  • Valley Research

    Fresno, California, 93720-2992

  • Florida Research Network, LLC

    Gainesville, Florida, 32605-4253

  • PharmQuest

    Greensboro, North Carolina, 27408

  • Excel Clinical Research, LLC

    Houston, Texas, 77081

  • Texas Center for Drug Development, Inc.

    Houston, Texas, 77081

  • Humble Cardiology Associates

    Humble, Texas, 77338

  • Del Rosario Medical Clinic, Inc.

    Huntington Park, California, 90255

  • Holston Medical Group

    Kingsport, Tennessee, 37660-3256

  • New Phase Research & Development

    Knoxville, Tennessee, 37923

  • Scripps Whittier Diabetes Institute

    La Jolla, California, 92037

  • National Research Institute

    Los Angeles, California, 90057

  • L-MARC Research Center

    Louisville, Kentucky, 40213

  • Clinical Research Advantage/Desert Clinical Research, LLC

    Mesa, Arizona, 85213

  • NewPhase Clinical Trials, Inc.

    Miami Beach, Florida, 33140

  • LaPorte County Institute for Clinical Research

    Michigan City, Indiana, 46360

  • Spectrum Clinical Research Institute, Inc

    Moreno Valley, California, 92553

  • Suncoast Clinical Research

    New Port Richey, Florida, 34652

  • Infinity Research Group, LLC

    Oklahoma City, Oklahoma, 73103

  • MD Medical Research

    Oxon Hill, Maryland, 20745

  • Paul W. Davis, MD, PA

    Pine Bluff, Arkansas, 71603

  • Sacramento Heart and Vascular Medical Associates

    Sacramento, California, 95825

  • Highland Clinical Research

    Salt Lake City, Utah, 84124

  • Jean Brown Research

    Salt Lake City, Utah, 84124

  • Cetero Research

    San Antonio, Texas, 78229

  • Cetero Research

    San Antonio, Texas, 78237

  • Regenerate Clinical Trials

    South Miami, Florida, 33143

  • Comprehensive Clinical Development, Inc.

    St. Petersburg, Florida, 33716

  • Southeastern Research Associates, Inc.

    Taylors, South Carolina, 29687

  • IRC Clinics, Inc

    Towson, Maryland, 21204

  • Desert Sun Clinical Research, LLC

    Tucson, Arizona, 85710

  • Eclipse Clinical Research

    Tucson, Arizona, 85745

  • Infosphere Clinical Research

    West Hills, California, 91307

  • Clinical Research of Central Florida

    Winter Haven, Florida, 33880

Other trials in United States

Russia36 sites

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

    Arkhangel'skoye, 143420

  • 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

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

    Krasnoyarsk, 660062

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

    Moscow, 117556

  • Central Clinical Hospital of Russian Academy of Sciences

    Moscow, 117593

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

    Moscow, 127299

  • City Clinical Hospital # 13 of Avtozavodsky District of Nizhniy Novgorod

    Nizhny Novgorod, 603018

  • Novosibirsk State Medical University

    Novosibirsk, 630087

  • Scientific Research Institute of Physiology of Siberian Department RAMS

    Novosibirsk, 630117

  • City Hospital # 38 named after N A Semashko

    Pushkin, 196601

  • Rostov State Medical University

    Rostov-on-Don, 344022

  • Ryazan State Medical University

    Ryazan, 390005

  • 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

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

    Saint Petersburg, 192283

  • 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

  • St. Elizabeth City Hospital

    Saint Petersburg, 195257

  • Krestovsky Island Medical Institute, LLC

    Saint Petersburg, 197042

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

    Saint Petersburg, 197341

  • International Medical Center "SOGAZ", LLC

    Saint Petersburg, 198168

  • Saint-Petersburg City Pokrovskaya Hospital

    Saint Petersburg, 199106

  • Center "Diabetes", LLC

    Samara, 443067

  • Smolensk State Medical Academy, Sanatorium-Preventorium

    Smolensk, 214019

  • Tyumen State Medical Academy

    Tyumen, 625023

  • Voronezh Regional Clinical Hospital #1

    Voronezh, 394082

  • City Hospital named after N.A.Semashko

    Yaroslavl, 150002

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

    Yaroslavl, 150003

  • Medical Sanitary Unit of Novo-Yaroslavsky Oil Refinery

    Yaroslavl, 150023

  • Yaroslavl Regional Clinical Hospital

    Yaroslavl, 150062

  • The Urals State Medical Academy

    Yekaterinburg, 620102

Other trials in Russia

Romania11 sites

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

    Bucharest, 020042

  • Tehnomed Trading Srl

    Bucharest, 020354

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

    Bucharest, 020475

  • O.D. Medica Srl

    Bucharest, 020725

  • CMI Mateescu S. Ana-Maria

    Constanța, 900675

  • CMI Morosanu V. Magdalena

    Galati, Galați County, 800371

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

    Galati, 800578

  • Consultmed SRL

    Iași, Jud. Iasi, 700547

  • Spital Clinic Judetean de Urgenta Oradea Stationarul 1

    Oradea, Jud Bihor, 410169

  • Diabmed Dr. Popescu Alexandrina SRL

    Ploieşti, 100163

  • Centru Medical Dr. Negrisanu

    Timișoara, Judical Timis, 300456

Other trials in Romania

South Africa10 sites

  • Centre for Diabetes and Endocrinology Suite 1

    Durban, 4091

  • Centre for Diabetes, Asthma and Allergy

    Johannesburg, 01829

  • Soweto Clinical Trial Centre

    Johannesburg, 1818

  • Centre fro Diabetes and Endocrinology (Pty) Ltd

    Johannesburg, 2198

  • Aliwal Shoal Medical & Clinical Trial Centre

    Kwa Zulu Natal, 4170

  • Newkwa Medical Centre

    Newlands West, Durban, 4037

  • Drs. Naiker and Naicker Inc.

    Overport, Durban, 4001

  • Paarl Research Centre

    Paarl, Cape Town, 7647

  • Helderberg Clinical Trials Centre

    Somerset West, 7130

  • Tiervlei Trial Centre

    Western Cape, 7530

Other trials in South Africa

Ukraine9 sites

  • City Clinical Hospital#9, Dnipropetrovsk State Medical Academy

    Dnipropetrovsk, 49023

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

    Donetsk, 83003

  • 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 Clinic # 2 of Shevchenkovsky District

    Kyiv, 04050

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

    Kyiv, 04114

  • Municipal Institution Lutsk City Clinical Hospital

    Lutsk, 43024

  • Lviv Regional Endocrinology Dispensary

    Lviv, 79010

  • Odessa State Medical University

    Odesa, 65039

  • Zhytomyr Regional Clinical Hospital

    Zhytomyr, 10002

Other trials in Ukraine

Poland8 sites

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

    Gdansk, Pomeranian Voivodeship, 80-546

  • LANDA - Specjalistyczne Gabinety Lekarskie

    Krakow, 30-015

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

    Lodz, 90-153

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

    Lodz, Łódź Voivodeship, 90-242

  • NZOZ Centrum Medyczne Szpital Sw. Rodziny

    Lodz, Łódź Voivodeship, 90-302

  • NZOZ Centrum Badan Klinicznych Oswiecim

    Oswięcim, 32-600

  • NZOZ Centrum Badan Klinicznych

    Wroclaw, Lower Silesian Voivodeship, 50-349

  • NZOZ Polimedica

    Zgierz, Łódź Voivodeship, 95-100

Other trials in Poland

Hungary6 sites

  • Drug Research Center

    Balatonfüred, 8230

  • Synexus Hungary Ltd

    Budapest, 1036

  • Markhot Ferenc Hospital

    Eger, 3300

  • Kanizsai Dorottya Hospital

    Nagykanizsa, 8800

  • Borbanya Praxis Kft., Outpatient Clinic

    Nyíregyháza, 4400

  • Medifarma 98

    Nyíregyháza, 4400

Other trials in Hungary

Slovakia5 sites

  • METABOLKLINIK s.r.o.

    Bratislava, Bratislava Region, 811 08

  • Metabolic Center of Dr. Katarina Raslova Ltd.

    Bratislava, Bratislava Region, 831 01

  • ENDIAMED s.r.o

    Dolný Kubín, Žilina Region, 02601

  • MediVet s.r.o.

    Malacky, 901 01

  • ARETEUS s.r.o., Diabetologicka ambulancia

    Trebišov, Košice Region, 07501

Other trials in Slovakia

Thailand4 sites

  • Phramongkutklao Hospital

    Bangkok, 10400

  • Rajavithi Hospital

    Bangkok, 10400

  • Chulalongkorn University

    Patumwan, Bangkok, 10330

  • Songklanagarind Hospital

    Songkhla, 90110

Other trials in Thailand

Serbia3 sites

  • Clinical Center of Serbia

    Belgrade, 11000

  • Zvezdara University Medical Center

    Belgrade, 11000

  • Clinical Center of Kragujevac

    Kragujevac, 34000

Other trials in Serbia

Czechia1 site

  • Interni oddeleni

    Havířov, Moravian-Silesian Region, 736 01

Other trials in Czechia

Malaysia1 site

  • Hospital Universiti Sains Malaysia

    Kubang Kerian, Kelantan, 16150

Other trials in Malaysia

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 Glimepiride in Subjects With Type 2 Diabetes Mellitus

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.

Being tested
Ranolazine, Placebo, Glimepiride, Diet, Exercise
Keywords
Type 2 Diabetes Mellitus
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

  • PlaceboDrug

    Placebo to match ranolazine for the duration of the study

  • GlimepirideDrug

    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.

  • 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 NCT01494987
Study groupRoleWhat they receive
Ranolazine+glimepirideExperimentalGlimepiride 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.
Receives: Drug: Ranolazine; Drug: Glimepiride; Behavioral: Diet; Behavioral: Exercise
Placebo+glimepiridePlacebo comparatorGlimepiride 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.
Receives: Drug: Placebo; Drug: Glimepiride; 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 (3)

  1. Change From Baseline in Incremental Change of 2-hour Postprandial Serum Glucose at Week 24

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

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

    Measured: Baseline; Week 24

  2. 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

  3. 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.

    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 posted19 Dec 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionAug 2013
  4. Study completionAug 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
431 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01494987
Sponsor's protocol ID
GS-US-259-0110
Status last verified
Nov 2014
First submitted
15 Dec 2011
Last updated
18 Nov 2014
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ranolazine, Glimepiride and Diet in people with Type 2 Diabetes Mellitus, run by Gilead Sciences at 140 sites in 12 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 15 inclusion and 32 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 18 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 140 sites in United States, Russia, Romania, South Africa, Ukraine and 7 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 1 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 NCT01494987.

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 18 Nov 2014.

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