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

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.

Study Overview

• Status: Completed
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: Ranolazine; Drug: Glimepiride; Behavioral: Diet; Behavioral: Exercise; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 431
• Phase: Phase 3

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written informed consent
• Males and females, 18 to 75 years old, inclusive
• Documented history of T2DM

• Receiving one of the following sulfonylurea or metformin therapies in addition to diet and exercise for at least 90 days prior to Screening:

  1. glimepiride at a daily dose of ≥ 2 mg and ≤ 4 mg
  2. glipizide, glyburide, or glibenclamide (or equivalent) at a daily dose of ≥ 7.5 mg
  3. gliclazide at a daily dose of > 160 mg (or ≥ 60 mg for the modified release [MR] formulation)
  4. metformin at a daily dose of ≥ 1500 mg
• Body mass index (BMI) 25 kg/m2 to 45 kg/m2, inclusive, at Screening
• HbA1c 7% to 10%, inclusive, at Screening and the end of the Qualifying Period (Day 14)
• Fasting Serum C-peptide ≥ 0.8 ng/mL at Screening
• Fasting serum glucose (FSG) ≥ 130 mg/dL (7.2 mmol/L) and ≤ 240 mg/dL (13.3 mmol/L) at Screening and at the end of the Qualifying Period (Day 14): A one-time central laboratory re-test of FSG is allowed in subjects with an initial central laboratory FSG ≥ 120 mg/dL (6.7 mmol/L) and < 130 mg/dL (7.2 mmol/L) who are otherwise eligible as determined by the investigator.
• Able and willing to comply with all study procedures during the course of the study
• Females of child-bearing potential must have a negative serum pregnancy test at Screening and must agree to use highly effective contraception methods from Screening throughout the duration of the Treatment Period and for 14 days following the last dose of study drug.
• At least 80% compliant in dosing during the Qualifying Period

Exclusion Criteria:

• History of or current diagnosis of type 1 diabetes mellitus
• History of diabetic ketoacidosis, ketosis-prone diabetes, or hyperosmolar hyperglycemic coma
• History of a severe episode of hypoglycemia (≥ 1 episode within 3 months prior to Screening or ≥ 2 episodes within 6 months prior to Screening), defined as hypoglycemia requiring 3rd party assistance to actively administer carbohydrate, glucagon, or other resuscitative actions due to severe impairment in consciousness or behavior
• Clinically significant complications of diabetes that in the judgment of the investigator would make the subject unsuitable to participate in this study
• History of any clinically significant cardiovascular (CV) or cerebrovascular event (eg, myocardial infarction [MI], acute coronary syndrome [ACS], recent revascularization [including coronary artery bypass graft procedures or percutaneous coronary intervention], transient ischemic attack, or ischemic stroke) ≤ 3 months prior to Screening
• Inadequately controlled or unstable hypertension as defined by a systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and at Randomization
• Prolonged QT interval corrected for heart rate (QTc) interval > 500 msec by electrocardiogram (ECG) at Screening, a personal or family history of QTc prolongation, congenital long QT syndrome, or subjects who are receiving drugs that prolong the QTc interval, such as Class Ia or Class III antiarrhythmic agents, erythromycin, and certain antipsychotics (eg, ziprasidone)
• History of bariatric surgery at any time in the past or or any other surgery < 2 months before Screening; or planning to undergo surgery during the study. Subjects with a planned minor surgery may be enrolled upon approval by the medical monitor.
• Any other hospitalization in the 14 days prior to Screening or planned hospitalization at any time during the study
• Significant weight change (± 5%) < 2 months prior to Screening or enrollment in a weight-loss program other than a maintenance phase at Screening.
• Severe renal impairment, defined as an estimated glomerular filtration rate (eGFR) by the Modification of Diet in Renal Disease (MDRD) equation < 30 mL/min/1.73 m2 at Screening or undergoing any type of dialysis at Screening or planning to undergo any type of dialysis during the course of the study
• History of liver cirrhosis (Child-Pugh Class A, B or C)
• Active liver disease and/or significant abnormal liver function defined as aspartate aminotransferase (AST) > 3 x upper limit of the normal range (ULN) and/or alanine aminotransferase (ALT) > 3 x ULN and/or serum total bilirubin > 2.0 mg/dL
• History of cancer (except nonmelanomic skin cancers or cervical in situ) within 5 years prior to Screening
• History of alcohol or other drug abuse < 12 months prior to Screening
• Any other clinically significant existing medical or psychiatric condition, including clinically significant laboratory abnormalities, or one requiring further evaluation that in the opinion of the investigator could interfere with conduct of the study or interpretation of the data
• Use of antihyperglycemic agents other than sulfonylurea agents or metformin, including but not limited to dipeptidyl peptidase-4 inhibitors (eg, saxagliptin and sitagliptin), glucagon-like peptide-mimetics (eg, exenatide), or insulin < 3 months prior to Screening; use of thiazolidinediones (TZDs) (eg, rosiglitazone or pioglitazone) < 24 weeks prior to Screening
• Previous history of intolerance of glimepiride (as a single-agent therapy)
• Prior treatment with open-label ranolazine, or known hypersensitivity or intolerance to ranolazine or any of its excipients
• Treatment with strong or moderate 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ranolazine+glimepiride; Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive ranolazine 500 mg twice daily plus glimepiride 4 mg once daily on Days 1 through 7, followed by ranolazine 1000 mg twice daily plus glimepiride 4 mg once daily from Day 8 (or by Day 16 if not well tolerated) through Week 24. Participants will be required to maintain their diet and exercise regimen.	Drug: Ranolazine; Ranolazine tablet(s) administered orally; Other Names: Ranexa®; Drug: Glimepiride; Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.; Behavioral: Diet; Participants are instructed to continue the diet regimen prescribed by their physician.; Behavioral: Exercise; Participants are instructed to continue the exercise regimen prescribed by their physician.
PLACEBO_COMPARATOR: Placebo+glimepiride; Glimepiride stabilization period (up to 8 weeks): participants not on stable glimepiride will receive glimepiride 2 mg once daily, and if tolerated the dose will be increased on Day 8 (+ 2 days) to 4 mg once daily. Qualifying period: participants will receive placebo to match ranolazine twice daily in addition to glimepiride for 14 days (+ 2 days) and if ≥ 80% compliant and meeting eligibility criteria will continue to the treatment period. Treatment period: participants will be randomized to receive placebo to match ranolazine plus glimepiride 4 mg once daily for 24 weeks. Participants will be required to maintain their diet and exercise regimen.	Drug: Glimepiride; Glimepiride tablets (2 mg or 4 mg) administered orally once daily with the morning dose of study drug or placebo. The target dosing regimen for glimepiride is 4 mg once daily.; Behavioral: Diet; Participants are instructed to continue the diet regimen prescribed by their physician.; Behavioral: Exercise; Participants are instructed to continue the exercise regimen prescribed by their physician.; Drug: Placebo; Placebo to match ranolazine for the duration of the study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24	The average (mean) change from baseline in HbA1c at Week 24 was analyzed.	Baseline; Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline; Week 24
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.	Baseline; Week 24
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.	Baseline; Week 24

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (ACTUAL): August 1, 2013
• Study Completion (ACTUAL): August 1, 2013

Study Registration Dates

• First Submitted: December 15, 2011
• First Submitted That Met QC Criteria: December 16, 2011
• First Posted (ESTIMATE): December 19, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): November 18, 2014
• Last Update Submitted That Met QC Criteria: November 5, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Type 2 Diabetes Mellitus
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Immunosuppressive Agents; Immunologic Factors; Membrane Transport Modulators; Sodium Channel Blockers; Glimepiride; Ranolazine
• Other Study ID Numbers: GS-US-259-0110