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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ranolazine
Placebo to match ranolazine
Metformin
Placebo to match metformin
Diet
Exercise
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

  • Fundamental Research LLC
  • KLR Business Group DBA Arkansas Clinical Research
  • Radiant Research, Inc.
  • Central Phoenix Medical Clinic
  • Clinical Research Advantage
  • Desert Sun Clinical Research, LLC
  • National Research Institute
  • Ritchken and First MD's
  • Clearview Medical Research, LLC
  • Metabolic Institute of America
  • University Clinical Investigators
  • Infosphere Clinical Research
  • Colorado Springs Health Partners
  • Boca Raton Clinical Research Associates, Inc.
  • MD Clinical Institute
  • A G A Clinical Trials
  • Baptist Diabetes Associates
  • Florida Institute for Clinical Research LLC
  • Medical Research Group of Central Florida
  • Synergy Therapeutic Partners
  • Perimeter Institute for Clinical Research
  • Columbus Research Foundation
  • Advanced Clinical Research
  • Choose To Lose
  • Cedar-Crosse Research Center
  • Alexandria Cardiology Clinic
  • Covington Medical Care
  • Clinical Trials Management, LLC
  • MD Medical Research
  • Bellevue Family Practice
  • Clinical Research Advantage
  • Albuquerque Clinical Trials, Inc.
  • University of New Mexico Health Sciences Center
  • PhysiqueMed Clinical Trials
  • Clinical Trials of America Inc
  • University Medical Associates
  • Northstate Clinical Research
  • Carolina Research Center
  • Lillestol Research
  • Rapid Medical Research, Inc
  • Columbus Clinical Research Inc.
  • Hometown Urgent Care and Research
  • Blair Medical Associates Inc.
  • Safe Harbor Clinical Research
  • Pharmacorp Clinical Trials, Inc.
  • DeGarmo Institute of Medical Research
  • Holston Medical Group, P.C.
  • New Phase Research & Development
  • Dallas Diabetes and Endocrine Center
  • West Houston Clinical Research
  • Juno Research, LLC
  • Texas Center for Drug Development, Inc.
  • Juno Research, LLC
  • Northeast Clinical Research of San Antonio, LLC
  • Progressive Clinical Research, LLC
  • Highland Clinical Research
  • Burke Internal Medicine, Inc.
  • Manassas Clinical Research Center
  • The Medical Arts Health Research Group
  • Diabetes Research Clinic
  • Joanne F. Liutkus Medicine Professional Corporation
  • Source Unique Research
  • Nemocnice s poliklinikou Havirov
  • Restrial s.r.o.
  • Synexus Hungary Ltd
  • Selye János Kórház és Rendel?intézet, Belgyógyászati Szakrendelés
  • Kanizsai Dorottya Hospital
  • Medifarma 98
  • Borbanya Praxis Kft., Outpatient Clinic
  • Diabetomics India
  • DHL Research Centre, 2nd Floor
  • Dia Care- A Complete Diabetes Care Center
  • Baroda Medical College and SSG Hospital
  • Banker's Heart Institute
  • Endocrinology & Diabetes Research Centre
  • Manipal Hospital
  • Endocrinology Diabetes Centre
  • Bangalore Diabetes Hospital
  • The Bangalore Diabetes Hospital
  • Jnana Sanjeevani Medical Center
  • Vinaya Hospital and Research Centre
  • Seth G. S. Medical College and KEM Hospital
  • Institue of Clinical Endocrinology (I.C.E) and Diabetes Care Unit (D.C.U),
  • Getwell Hospital and Research Institute
  • Diabetes Care and Research Centre
  • KEM Hospital Research Center
  • Fortis City Centre
  • Diabetes and Heart Centre
  • Swamy Diabetes Centre
  • Madras Diabetes Research Foundation
  • Kovai Diabetes Speciality Centre & Hospital
  • Soroka University Medical Center
  • Edith Wolfson Medical Center
  • Ziv Medical Center Safed-Israel
  • Instituto Jalisciense de Investigación en Diabetes y Obesidad
  • Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna
  • LANDA - Specjalistyczne Gabinety Lekarskie
  • Niepubliczy Zaklad Opieki Zdrowotnej (NZOZ) Specjalistyczny Osrodek Internistyczno - Diabetologiczny
  • NZOZ "Esculap" S.C.
  • GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF
  • Clinic of New Medical Technology Company Limited
  • Kemerovo Regional Clinical Hospital
  • State Institution of Public Health of Moscow City Endocrinology Dispensary
  • Novosibirsk State Medical University
  • Reafan, LLC
  • Rostov State Medical University
  • Ryazan State Medical University
  • Center "Diabetes", LLC
  • Smolensk State Medical Academy, Sanatorium-Preventorium
  • Medinet, LLC
  • North-Western State Medical Unversity n.a. I.I.Mechnikov
  • Saint-Petersburg City Outpatient Clinic#37
  • Military Medical Academy named after S.M. Kirov
  • City Diabetology Center #4, "City Polyclinic #77"
  • Alexanders City Hospital
  • Clinical Hospital #122 n.a. Sokolov of FMBA
  • ANO Medical Centre XXI Century
  • City Hospital #38 named after N. A. Semashko
  • Krestovsky Island Medical Institute, LLC
  • Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov
  • Federal State Budget Military Educational Institution Medical Military Academy n. a. S. M. Kirov
  • SPb GBUZ Diagnostic Center #85
  • City Hospital named after N.A.Semashko
  • Yaroslavl Regional Clinical Hospital
  • Centre for Diabetes and Endocrinology Suite 1
  • Vawda Z Private Practice
  • Newkwa Medical Centre
  • Drs. Naiker and Naicker Inc.
  • Synexus Clinical Research SA (Pty) Ltd
  • East Rand Research Trading as Worthwhile Clinical Trials
  • Charlotte Maxeke Johannesburg Academic Hospital
  • Aliwal Shoal Medical & Clinical Trial Centre
  • Netcare Umhlanga Medical Centre
  • Helderberg Clinical Trials Centre
  • Educational Scientific Medical Centre, Donetsk National Medical University
  • State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukra
  • Ukrainian Scientific-and-Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs
  • Department of Endocrinology of Railway Clinical Hospital #2 of station "Kyiv" of South East Railroad
  • Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
  • National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clini
  • V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine
  • Odessa State Medical University
  • Odessa City Policlinic #20
  • Vinnytsya Regional Clinical Endocrinology Dispensary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ranolazine+metformin

Placebo+metformin

Arm Description

Qualifying 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.

Qualifying 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.

Outcomes

Primary Outcome Measures

Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
The average (mean) change from baseline in HbA1c at Week 24 was analyzed.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
March 13, 2012
Last Updated
September 17, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01555164
Brief Title
A Phase 3 Study of Ranolazine in Subjects With Type 2 Diabetes Who Are Inadequately Controlled on Metformin Alone
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
June 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 to diet and exercise.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
442 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ranolazine+metformin
Arm Type
Experimental
Arm Description
Qualifying 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.
Arm Title
Placebo+metformin
Arm Type
Placebo Comparator
Arm Description
Qualifying 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.
Intervention Type
Drug
Intervention Name(s)
Ranolazine
Other Intervention Name(s)
Ranexa®
Intervention Description
Ranolazine tablet(s) administered orally
Intervention Type
Drug
Intervention Name(s)
Placebo to match ranolazine
Intervention Description
Placebo to match ranolazine for the duration of the study
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin tablet(s) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match metformin
Intervention Description
Placebo to match metformin for the duration of the study
Intervention Type
Behavioral
Intervention Name(s)
Diet
Intervention Description
Participants are instructed to continue the diet regimen prescribed by their physician.
Intervention Type
Behavioral
Intervention Name(s)
Exercise
Intervention Description
Participants are instructed to continue the exercise regimen prescribed by their physician.
Primary Outcome Measure Information:
Title
Change From Baseline in Glycosylated Hemoglobin (HbA1c) at Week 24
Description
The average (mean) change from baseline in HbA1c at Week 24 was analyzed.
Time Frame
Baseline; Week 24
Secondary Outcome Measure Information:
Title
Change From Baseline in Fasting Serum Glucose at Week 24
Description
The average (mean) change from baseline in fasting serum glucose at Week 24 was analyzed.
Time Frame
Baseline; Week 24
Title
Change From Baseline in 2-hour Postprandial Serum Glucose at Week 24
Description
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.
Time Frame
Baseline; Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patrick Yue, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Fundamental Research LLC
City
Gulf Shores
State/Province
Alabama
ZIP/Postal Code
36542
Country
United States
Facility Name
KLR Business Group DBA Arkansas Clinical Research
City
Little Rock
State/Province
Alaska
ZIP/Postal Code
72205
Country
United States
Facility Name
Radiant Research, Inc.
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Clinical Research Advantage
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Desert Sun Clinical Research, LLC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
National Research Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90057
Country
United States
Facility Name
Ritchken and First MD's
City
San Diego
State/Province
California
ZIP/Postal Code
92117
Country
United States
Facility Name
Clearview Medical Research, LLC
City
Santa Clarita
State/Province
California
ZIP/Postal Code
91350
Country
United States
Facility Name
Metabolic Institute of America
City
Tarzana
State/Province
California
ZIP/Postal Code
91356
Country
United States
Facility Name
University Clinical Investigators
City
Tustin
State/Province
California
ZIP/Postal Code
92780
Country
United States
Facility Name
Infosphere Clinical Research
City
West Hills
State/Province
California
ZIP/Postal Code
91307
Country
United States
Facility Name
Colorado Springs Health Partners
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80906
Country
United States
Facility Name
Boca Raton Clinical Research Associates, Inc.
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33432
Country
United States
Facility Name
MD Clinical Institute
City
Hallandale Beach
State/Province
Florida
ZIP/Postal Code
33009
Country
United States
Facility Name
A G A Clinical Trials
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Baptist Diabetes Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Florida Institute for Clinical Research LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Sanford
State/Province
Florida
ZIP/Postal Code
32771
Country
United States
Facility Name
Synergy Therapeutic Partners
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30312
Country
United States
Facility Name
Perimeter Institute for Clinical Research
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30338
Country
United States
Facility Name
Columbus Research Foundation
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Advanced Clinical Research
City
Boise
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
Choose To Lose
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Cedar-Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
Alexandria Cardiology Clinic
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Covington Medical Care
City
Mandeville
State/Province
Louisiana
ZIP/Postal Code
70471
Country
United States
Facility Name
Clinical Trials Management, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
MD Medical Research
City
Oxon Hill
State/Province
Maryland
ZIP/Postal Code
20745
Country
United States
Facility Name
Bellevue Family Practice
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68005
Country
United States
Facility Name
Clinical Research Advantage
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Albuquerque Clinical Trials, Inc.
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
University of New Mexico Health Sciences Center
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87131-0001
Country
United States
Facility Name
PhysiqueMed Clinical Trials
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27405
Country
United States
Facility Name
Clinical Trials of America Inc
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
University Medical Associates
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Northstate Clinical Research
City
Lenoir
State/Province
North Carolina
ZIP/Postal Code
28645
Country
United States
Facility Name
Carolina Research Center
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150
Country
United States
Facility Name
Lillestol Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Rapid Medical Research, Inc
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Columbus Clinical Research Inc.
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43213
Country
United States
Facility Name
Hometown Urgent Care and Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Blair Medical Associates Inc.
City
Altoona
State/Province
Pennsylvania
ZIP/Postal Code
16602
Country
United States
Facility Name
Safe Harbor Clinical Research
City
East Providence
State/Province
Rhode Island
ZIP/Postal Code
02914
Country
United States
Facility Name
Pharmacorp Clinical Trials, Inc.
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29412
Country
United States
Facility Name
DeGarmo Institute of Medical Research
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Holston Medical Group, P.C.
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
New Phase Research & Development
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37923
Country
United States
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Dallas Diabetes and Endocrine Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230
Country
United States
Facility Name
West Houston Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Juno Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77074
Country
United States
Facility Name
Texas Center for Drug Development, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Juno Research, LLC
City
Katy
State/Province
Texas
ZIP/Postal Code
77450
Country
United States
Facility Name
Northeast Clinical Research of San Antonio, LLC
City
Schertz
State/Province
Texas
ZIP/Postal Code
78154
Country
United States
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Progressive Clinical Research, LLC
City
Bountiful
State/Province
Utah
ZIP/Postal Code
84010
Country
United States
Facility Name
Highland Clinical Research
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Burke Internal Medicine, Inc.
City
Burke
State/Province
Virginia
ZIP/Postal Code
22015
Country
United States
Facility Name
Manassas Clinical Research Center
City
Manassas
State/Province
Virginia
ZIP/Postal Code
20110
Country
United States
Facility Name
The Medical Arts Health Research Group
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 3G8
Country
Canada
Facility Name
Diabetes Research Clinic
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1L8
Country
Canada
Facility Name
Joanne F. Liutkus Medicine Professional Corporation
City
Cambridge
State/Province
Ontario
ZIP/Postal Code
N1R7L6
Country
Canada
Facility Name
Source Unique Research
City
Hawkesbury
State/Province
Ontario
ZIP/Postal Code
K6A 1A1
Country
Canada
Facility Name
Nemocnice s poliklinikou Havirov
City
Havirov
State/Province
Moravskoslezsky kraj
ZIP/Postal Code
736-01
Country
Czech Republic
Facility Name
Restrial s.r.o.
City
Praha 8
State/Province
Praha
ZIP/Postal Code
18100
Country
Czech Republic
Facility Name
Synexus Hungary Ltd
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Facility Name
Selye János Kórház és Rendel?intézet, Belgyógyászati Szakrendelés
City
Komárom
ZIP/Postal Code
2900
Country
Hungary
Facility Name
Kanizsai Dorottya Hospital
City
Nagykanizsa
ZIP/Postal Code
8800
Country
Hungary
Facility Name
Medifarma 98
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Borbanya Praxis Kft., Outpatient Clinic
City
Nyíregyháza
ZIP/Postal Code
4405
Country
Hungary
Facility Name
Diabetomics India
City
Hyderabad
State/Province
Andhra Pradesh
ZIP/Postal Code
500034
Country
India
Facility Name
DHL Research Centre, 2nd Floor
City
Ahmadabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Dia Care- A Complete Diabetes Care Center
City
Ahmadabad
State/Province
Gujarat
ZIP/Postal Code
380015
Country
India
Facility Name
Baroda Medical College and SSG Hospital
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390001
Country
India
Facility Name
Banker's Heart Institute
City
Vadodara
State/Province
Gujarat
ZIP/Postal Code
390015
Country
India
Facility Name
Endocrinology & Diabetes Research Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560003
Country
India
Facility Name
Manipal Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560017
Country
India
Facility Name
Endocrinology Diabetes Centre
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560038
Country
India
Facility Name
Bangalore Diabetes Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560043
Country
India
Facility Name
The Bangalore Diabetes Hospital
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560052
Country
India
Facility Name
Jnana Sanjeevani Medical Center
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
560078
Country
India
Facility Name
Vinaya Hospital and Research Centre
City
Mangalore
State/Province
Karnataka
ZIP/Postal Code
575003
Country
India
Facility Name
Seth G. S. Medical College and KEM Hospital
City
Mumbai
State/Province
Maharashtra
ZIP/Postal Code
400012
Country
India
Facility Name
Institue of Clinical Endocrinology (I.C.E) and Diabetes Care Unit (D.C.U),
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440010
Country
India
Facility Name
Getwell Hospital and Research Institute
City
Nagpur
State/Province
Maharashtra
ZIP/Postal Code
440012
Country
India
Facility Name
Diabetes Care and Research Centre
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
KEM Hospital Research Center
City
Pune
State/Province
Maharashtra
ZIP/Postal Code
411011
Country
India
Facility Name
Fortis City Centre
City
Chandigarh
State/Province
Punjab
ZIP/Postal Code
160017
Country
India
Facility Name
Diabetes and Heart Centre
City
Ludhiana
State/Province
Punjab
ZIP/Postal Code
141008
Country
India
Facility Name
Swamy Diabetes Centre
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600028
Country
India
Facility Name
Madras Diabetes Research Foundation
City
Chennai
State/Province
Tamilnadu
ZIP/Postal Code
600086
Country
India
Facility Name
Kovai Diabetes Speciality Centre & Hospital
City
Coimbatore
State/Province
Tamilnadu
ZIP/Postal Code
641009
Country
India
Facility Name
Soroka University Medical Center
City
Beer Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Edith Wolfson Medical Center
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
Ziv Medical Center Safed-Israel
City
Safed
ZIP/Postal Code
13100
Country
Israel
Facility Name
Instituto Jalisciense de Investigación en Diabetes y Obesidad
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44600
Country
Mexico
Facility Name
Centrum Terapii Wspolczesnej J.M. Jasnorzewska Sp. Komandytowo - Akcyjna
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90242
Country
Poland
Facility Name
LANDA - Specjalistyczne Gabinety Lekarskie
City
Krakow
State/Province
Malopolskie
ZIP/Postal Code
30-015
Country
Poland
Facility Name
Niepubliczy Zaklad Opieki Zdrowotnej (NZOZ) Specjalistyczny Osrodek Internistyczno - Diabetologiczny
City
Bialystok
ZIP/Postal Code
15-435
Country
Poland
Facility Name
NZOZ "Esculap" S.C.
City
Gniewkowo
ZIP/Postal Code
88-140
Country
Poland
Facility Name
GOU VPO "Chita State Medical Academy" of Minzdravsocrazvitie RF
City
Chita
ZIP/Postal Code
672090
Country
Russian Federation
Facility Name
Clinic of New Medical Technology Company Limited
City
Dzerzhinskiy
ZIP/Postal Code
140091
Country
Russian Federation
Facility Name
Kemerovo Regional Clinical Hospital
City
Kemerovo
ZIP/Postal Code
650066
Country
Russian Federation
Facility Name
State Institution of Public Health of Moscow City Endocrinology Dispensary
City
Moscow
ZIP/Postal Code
119034
Country
Russian Federation
Facility Name
Novosibirsk State Medical University
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
Reafan, LLC
City
Novosibirsk
ZIP/Postal Code
630099
Country
Russian Federation
Facility Name
Rostov State Medical University
City
Rostov-on-Don
ZIP/Postal Code
344022
Country
Russian Federation
Facility Name
Ryazan State Medical University
City
Ryazan
ZIP/Postal Code
29005
Country
Russian Federation
Facility Name
Center "Diabetes", LLC
City
Samara
ZIP/Postal Code
443067
Country
Russian Federation
Facility Name
Smolensk State Medical Academy, Sanatorium-Preventorium
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Medinet, LLC
City
St. Petersburg
ZIP/Postal Code
190000
Country
Russian Federation
Facility Name
North-Western State Medical Unversity n.a. I.I.Mechnikov
City
St. Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
Saint-Petersburg City Outpatient Clinic#37
City
St. Petersburg
ZIP/Postal Code
191119
Country
Russian Federation
Facility Name
Military Medical Academy named after S.M. Kirov
City
St. Petersburg
ZIP/Postal Code
191124
Country
Russian Federation
Facility Name
City Diabetology Center #4, "City Polyclinic #77"
City
St. Petersburg
ZIP/Postal Code
192012
Country
Russian Federation
Facility Name
Alexanders City Hospital
City
St. Petersburg
ZIP/Postal Code
193312
Country
Russian Federation
Facility Name
Clinical Hospital #122 n.a. Sokolov of FMBA
City
St. Petersburg
ZIP/Postal Code
194291
Country
Russian Federation
Facility Name
ANO Medical Centre XXI Century
City
St. Petersburg
ZIP/Postal Code
194354
Country
Russian Federation
Facility Name
City Hospital #38 named after N. A. Semashko
City
St. Petersburg
ZIP/Postal Code
196601
Country
Russian Federation
Facility Name
Krestovsky Island Medical Institute, LLC
City
St. Petersburg
ZIP/Postal Code
197042
Country
Russian Federation
Facility Name
Federal Centre of Heart, Blood and Endocrinology named after V.A. Almazov
City
St. Petersburg
ZIP/Postal Code
197341
Country
Russian Federation
Facility Name
Federal State Budget Military Educational Institution Medical Military Academy n. a. S. M. Kirov
City
St. Petersburg
ZIP/Postal Code
198013
Country
Russian Federation
Facility Name
SPb GBUZ Diagnostic Center #85
City
St. Petersburg
ZIP/Postal Code
198255
Country
Russian Federation
Facility Name
City Hospital named after N.A.Semashko
City
Yaroslavl
ZIP/Postal Code
150002
Country
Russian Federation
Facility Name
Yaroslavl Regional Clinical Hospital
City
Yaroslavl
ZIP/Postal Code
150062
Country
Russian Federation
Facility Name
Centre for Diabetes and Endocrinology Suite 1
City
Congella
State/Province
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Vawda Z Private Practice
City
Kwa Zulu Natal
State/Province
Durban
ZIP/Postal Code
4091
Country
South Africa
Facility Name
Newkwa Medical Centre
City
Newlands West
State/Province
Durban
ZIP/Postal Code
4037
Country
South Africa
Facility Name
Drs. Naiker and Naicker Inc.
City
Overport
State/Province
Durban
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Synexus Clinical Research SA (Pty) Ltd
City
Meyerspark
State/Province
Pretoria
ZIP/Postal Code
0102
Country
South Africa
Facility Name
East Rand Research Trading as Worthwhile Clinical Trials
City
Benoni
ZIP/Postal Code
1500
Country
South Africa
Facility Name
Charlotte Maxeke Johannesburg Academic Hospital
City
Johannesburg
ZIP/Postal Code
2193
Country
South Africa
Facility Name
Aliwal Shoal Medical & Clinical Trial Centre
City
Kwa Zulu Natal
ZIP/Postal Code
4170
Country
South Africa
Facility Name
Netcare Umhlanga Medical Centre
City
Kwa Zulu Natal
ZIP/Postal Code
4320
Country
South Africa
Facility Name
Helderberg Clinical Trials Centre
City
Somerset West
ZIP/Postal Code
7129
Country
South Africa
Facility Name
Educational Scientific Medical Centre, Donetsk National Medical University
City
Donetsk
ZIP/Postal Code
83003
Country
Ukraine
Facility Name
State Institution "Institute of Problems of Endocrine Pathology n.a. V.Y. Danylevsky of NAMS of Ukra
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
Ukrainian Scientific-and-Practical Center of Endocrine Surgery, Transplantation of Endocrine Organs
City
Kyiv
ZIP/Postal Code
02175
Country
Ukraine
Facility Name
Department of Endocrinology of Railway Clinical Hospital #2 of station "Kyiv" of South East Railroad
City
Kyiv
ZIP/Postal Code
03049
Country
Ukraine
Facility Name
Administration of Medical Service and Rehabilitation of "ARTEM" State Holding Company
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
National Medical University n.a. O.O. Bogomolets, Chair of Family Medicine based on Outpatient Clini
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
V. P. Komissarenko Institute of Endocrinology and Metabolism of AMS of Ukraine
City
Kyiv
ZIP/Postal Code
04114
Country
Ukraine
Facility Name
Odessa State Medical University
City
Odesa
ZIP/Postal Code
65039
Country
Ukraine
Facility Name
Odessa City Policlinic #20
City
Odesa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
Vinnytsya Regional Clinical Endocrinology Dispensary
City
Vinnytsya
ZIP/Postal Code
21010
Country
Ukraine

12. IPD Sharing Statement

Learn more about this trial

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

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