A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities

A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES

This randomized, double-blind, placebo-controlled, parallel group, multicenter study will evaluate the potential of aleglitazar to reduce cardiovascular risk in patients with stable cardiovascular disease and glucose abnormalities. Patients will be randomized 1:1 to receive either aleglitazar 150 mcg orally daily or matching placebo.

Study Overview

• Status: Completed
• Conditions: Cardiovascular Disease, Diabetes Mellitus Type 2
• Intervention / Treatment: Drug: aleglitazar; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 1999
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1119ACN
  • Caba, Argentina, C1428DCO
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
    • Gosford, New South Wales, Australia, 2250
    • Kogarah, New South Wales, Australia, 2217
    • Wollongong, New South Wales, Australia, 2500
  • Queensland
    • South Brisbane, Queensland, Australia, 4101
  • South Australia
    • Adelaide, South Australia, Australia, 5000
    • Woodville, South Australia, Australia, 5011
  • Tasmania
    • Launceston, Tasmania, Australia, 7250
  • Victoria
    • Geelong, Victoria, Australia, 3220
    • Heidelberg, Victoria, Australia, 3081
    • Melbourne, Victoria, Australia, 3004
  • Western Australia
    • Armadale, Western Australia, Australia, 6112
    • Perth, Western Australia, Australia, 6009
• Austria
  • Braunau, Austria, 5280
  • Feldkirch, Austria, 6800
  • Graz, Austria, 8036
  • Wien, Austria, 1130
• Canada
  • Quebec, Canada, G3K 2P8
  • British Columbia
    • Kelowna, British Columbia, Canada, V1Y 1E4
    • Surrey, British Columbia, Canada, V3V 1Z2
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3E 3P4
  • New Brunswick
    • Bathurst, New Brunswick, Canada, E2A 4X7
  • Ontario
    • Cambridge, Ontario, Canada, N1R 6V6
    • Collingwood, Ontario, Canada, L9Y 1W3
    • Hamilton, Ontario, Canada, L8L 2X2
    • London, Ontario, Canada, N5W 6A2
    • London, Ontario, Canada, N6G 0J4
    • New Market, Ontario, Canada, L3Y 5G8
    • NewMarket, Ontario, Canada, L3Y 8C3
    • Sarnia, Ontario, Canada, N7T 4X3
    • Sudbury, Ontario, Canada, P3C 5K7
    • Toronto, Ontario, Canada, M5G 2C4
    • Toronto, Ontario, Canada, M9V 4B4
  • Prince Edward Island
    • Quebec, Prince Edward Island, Canada, G1V 4G2
  • Quebec
    • Chicoutimi, Quebec, Canada, G7H 5H6
    • Chicoutimi, Quebec, Canada, G7H 7Y8
    • Granby, Quebec, Canada, J2G 8Z9
    • Lachine, Quebec, Canada, H8S 2E4
    • Laval, Quebec, Canada, H7M 3L9
    • Longueuil, Quebec, Canada, J4M 2X1
    • Montreal, Quebec, Canada, H1T 1C8
    • Montreal, Quebec, Canada, H3G 1A4
    • Montreal, Quebec, Canada, H1T 3Y7
    • Montreal, Quebec, Canada, H2P 2M1
    • Montréal, Quebec, Canada, H4N 2W2
    • Sherbrooke, Quebec, Canada, J1H 5N4
    • St-Charles Borromee, Quebec, Canada, J6E 6J2
    • St-Lambert, Quebec, Canada, J4P 2H4
    • St. Jerome, Quebec, Canada, J7Z 5T3
    • Ste-Foy, Quebec, Canada, G1W 4R4
    • Terrebonne, Quebec, Canada, J6V 1S8
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 3H3
• Chile
  • Las Condes, Chile, 7500710
  • Santiago, Chile, 7500710
  • Santiago, Chile, 7500010
  • Santiago, Chile, 7500347
  • Temuco, Chile, 4781156
  • Temuco, Chile, 4790869
  • Temuco, Chile, 4813299
• Colombia
  • Barranquila, Colombia
  • Barranquilla, Colombia
  • Bogota, Colombia
  • Bogotá, Colombia
  • Cartagena, Colombia
  • Floridablanca, Colombia
  • Medellin, Colombia
• Czech Republic
  • Beroun, Czech Republic, 266 01
  • Brno, Czech Republic, 625 00
  • Brno, Czech Republic, 601 77
  • Jihlava, Czech Republic, 586 33
  • Liberec, Czech Republic, 460 63
  • Praha, Czech Republic, 150 30
  • Praha 10, Czech Republic, 100 34
  • Praha 2, Czech Republic, 128 08
  • Praha 4, Czech Republic, 140 21
  • Praha 4, Czech Republic, 140 59
  • Praha 4, Czech Republic, 149 00
  • Praha 4 - Krc, Czech Republic, 140 59
  • Praha 5, Czech Republic, 150 06
  • Praha 5, Czech Republic, 158 00
  • Slany, Czech Republic, 274 51
  • Trebic, Czech Republic, 674 01
• Estonia
  • Narva, Estonia, 20307
  • Tallinn, Estonia, 10138
  • Tartu, Estonia, 51014
  • Tartu, Estonia, 50410
• Germany
  • Berlin, Germany, 10117
  • Berlin, Germany, 13125
  • Berlin-Charlottenburg, Germany, 14050
  • Bochum, Germany, 44787
  • Chemnitz, Germany, 09111
  • Damme, Germany, 49401
  • Dresden, Germany, 01067
  • Frankfurt, Germany, 65929
  • Frankfurt, Germany, 60596
  • Hannover, Germany, 30159
  • Homburg/Saar, Germany, 66421
  • Kassel, Germany, 34121
  • Koethen, Germany, 06366
  • Köln, Germany, 50937
  • Leipzig, Germany, 04103
  • Magdeburg, Germany, 39104
  • Moenchengladbach, Germany, 41063
  • Münster, Germany, 48145
  • Neunkirchen, Germany, 66539
  • Wangen, Germany, 88239
• Hungary
  • Balatonfuered, Hungary, 8230
  • Budapest, Hungary, 1125
  • Budapest, Hungary, 1085
  • Budapest, Hungary, 1036
  • Budapest, Hungary, 1097
  • Budapest, Hungary, 1027
  • Budapest, Hungary, 1023
  • Budapest, Hungary, 1131
  • Debrecen, Hungary, 4032
  • Gyöngyös, Hungary, 3200
  • Mosonmagyarovar, Hungary, 9200
  • Nyíregyháza, Hungary, 4400
  • Papa, Hungary, 8500
  • Szeged, Hungary, 6720
  • Szekesfehervar, Hungary, 8000
  • Szolnok, Hungary, 5004
  • Zalaegerszeg, Hungary, 8900
• Israel
  • Givatayim, Israel, 53583
• Italy
  • Campania
    • Naples, Campania, Italy, 80122
    • Napoli, Campania, Italy, 80131
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40133
  • Lazio
    • Roma, Lazio, Italy, 00128
    • Rome, Lazio, Italy, 00185
  • Lombardia
    • Milano, Lombardia, Italy, 20132
    • Milano, Lombardia, Italy, 20138
    • Pavia, Lombardia, Italy, 27100
  • Marche
    • Pesaro, Marche, Italy, 61121
  • Sicilia
    • Catania, Sicilia, Italy, 95122
    • Palermo, Sicilia, Italy, 90127
  • Toscana
    • Massa, Toscana, Italy, 54100
• Japan
  • Tochigi, Japan, 329-0498
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
  • Busan, Korea, Republic of, 602-715
  • Daejeon, Korea, Republic of, 35015
  • Gwangju, Korea, Republic of, 61469
  • Gyeonggi-Do, Korea, Republic of, 431-070
  • Gyeonggi-do, Korea, Republic of, 443-380
  • Gyeonggi-do, Korea, Republic of, 10380
  • Gyeonggi-do, Korea, Republic of, 11765
  • Gyeonggi-do, Korea, Republic of, 410-773
  • Incheon, Korea, Republic of, 405-760
  • Seoul, Korea, Republic of, 137-701
  • Seoul, Korea, Republic of, 130-872
  • Seoul, Korea, Republic of, 156-707
  • Seoul, Korea, Republic of, 05030
  • Seoul, Korea, Republic of, 06273
  • Suwon-si,, Korea, Republic of, 442-723
  • Wonju, Korea, Republic of, 220-701
• Latvia
  • Liepaja, Latvia, 3400
  • Riga, Latvia, LV-1002
  • Riga, Latvia, LV-1012
  • Riga, Latvia, LV-1024
  • Riga, Latvia, LV-1058
• Lithuania
  • Kaunas, Lithuania, 48259
  • Kaunas, Lithuania, 50184
  • Kaunas, Lithuania, LT-47144
  • Vilnius, Lithuania, LT-02169
• Malaysia
  • Johor, Malaysia, 80100
  • Kuala Lumpur, Malaysia, 59100
  • Perak, Malaysia, 34000
  • Sabah, Malaysia, 88300
  • Sarawak, Malaysia, 94300
  • Selangor, Malaysia, 68100
• Mexico
  • Aguascalientes, Mexico, 20234
  • Mexico, Mexico, 03300
  • Monclova, Mexico, 25750
  • Monterrey, Mexico, 64460
  • Xalapa, Mexico, 91020
• Poland
  • Bialystok, Poland, 15-276
  • Gdynia, Poland, 81-384
  • Gdynia, Poland, 81-472
  • Katowice, Poland, 40-748
  • Katowice, Poland, 40-954
  • Krakow, Poland, 31-202
  • Krakow, Poland, 31-261
  • Krakow, Poland, 30-015
  • Krakow, Poland, 30-082
  • Lodz, Poland, 90-242
  • Lublin, Poland, 20-044
  • Lublin, Poland, 20-093
  • Nowy Sacz, Poland, 33-300
  • Opole, Poland, 45-367
  • Rzeszow, Poland, 35-055
  • Warsawa, Poland, 01-192
  • Wroclaw, Poland, 50-088
• Romania
  • Baia Mare, Romania, 430123
  • Bucharest, Romania, 010507
  • Bucharest, Romania, 061119
  • Bucharest, Romania, 800578
  • Bucuresti, Romania, 010825
  • Bucuresti, Romania, 050098
  • Bucuresti, Romania, 020359
  • Craiova, Romania, 200642
  • Oradea, Romania, 410169
  • Ploiesti, Romania, 100163
  • Targu-Mures, Romania, 540124
• Russian Federation
  • Kemerovo, Russian Federation
  • Saint Petersburg, Russian Federation, 199034
  • Tomsk, Russian Federation, 634012
• South Africa
  • Pretoria, South Africa, 0103
  • Pretoria-West, South Africa, 0183
• Spain
  • Albacete, Spain, 02006
  • Almeria, Spain, 04009
  • Barcelona, Spain, 08036
  • Barcelona, Spain
  • Barcelona, Spain, 08003
  • Barcelona, Spain, 08035
  • Girona, Spain, 17007
  • Granada, Spain, 18012
  • Huelva, Spain, 21005
  • Madrid, Spain, 41013
  • Malaga, Spain, 29010
  • Malaga, Spain, 29006
  • Tarragona, Spain, 43007
  • Valencia, Spain, 46014
  • Alicante
    • San Juan de Alicante, Alicante, Spain, 3550
  • Barcelona
    • Hospitalet de Llobregat, Barcelona, Spain, 08907
  • Islas Baleares
    • Palma de Mallorca, Islas Baleares, Spain, 07014
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain, 15706
  • Lerida
    • Lleida, Lerida, Spain, 25198
  • Malaga
    • Málaga, Malaga, Spain, 29009
  • Sevilla
    • Seville, Sevilla, Spain, 41009
  • Valencia
    • Alzira, Valencia, Spain, 46600
• Sweden
  • Malmö, Sweden, 205 02
  • Stockholm, Sweden, 171 76
  • Stockholm, Sweden, 111 35
  • Stockholm, Sweden, 113 61
• Thailand
  • Bangkok, Thailand, 10330
  • Khon Kaen, Thailand, 40002
• United Kingdom
  • Birmingham, United Kingdom, B15 2SQ
  • Cardiff, United Kingdom, CF14 5GJ
  • Chorley, United Kingdom, PR7 7NA
  • Edinburgh, United Kingdom, EH16 4TJ
  • Glasgow, United Kingdom, G20 0SP
  • Glasgow, United Kingdom, G12 8QQ
  • Inverness, United Kingdom, IV2 4AG
  • Liverpool, United Kingdom, L9 7AL
  • Liverpool, United Kingdom, L22 0LG
  • Manchester, United Kingdom, M15 6SX
  • Mortimer, United Kingdom, RG7 3SQ
  • Reading, United Kingdom, RG2 0TG
  • Soham, Ely, United Kingdom, CB7 5JD
• United States
  • Alabama
    • Muscle Shoals, Alabama, United States, 35662
  • Arizona
    • Gilbert, Arizona, United States, 85295
    • Phoenix, Arizona, United States, 85018
    • Tucson, Arizona, United States, 85724
  • California
    • Cudahy, California, United States, 90201
    • Encino, California, United States, 91436
    • Fresno, California, United States, 93720
    • Fresno, California, United States, 93721
    • Hawaiian Gardens, California, United States, 90716
    • Huntington Beach, California, United States, 92646
    • Lomita, California, United States, 90717
    • Long Beach, California, United States, 90807
    • Los Angeles, California, United States, 90036
    • Los Angeles, California, United States, 90017
    • Los Angeles, California, United States, 90057
    • Los Gatos, California, United States, 95032
    • North Hollywood, California, United States, 91606
    • Northridge, California, United States, 91325
    • Roseville, California, United States, 95661
    • Sacramento, California, United States, 95821
    • San Diego, California, United States, 92103
    • Stockton, California, United States, 95207
    • Thousand Oaks, California, United States, 91360
    • Torrance, California, United States, 90502
    • Tustin, California, United States, 92780
    • Ventura, California, United States, 90265
  • Colorado
    • Denver, Colorado, United States, 80209
  • Florida
    • Atlantis, Florida, United States, 33462
    • Bradenton, Florida, United States, 34208
    • Brooksville, Florida, United States, 34601
    • Clearwater, Florida, United States, 33756
    • Clearwater, Florida, United States, 33755
    • DeLand, Florida, United States, 32720
    • Fort Lauderdale, Florida, United States, 33316
    • Hialeah, Florida, United States, 33012
    • Hialeah, Florida, United States, 33013
    • Kissimmee, Florida, United States, 34741
    • Miami, Florida, United States, 33144
    • Miami, Florida, United States, 33135
    • Miami Beach, Florida, United States, 33140
    • New Port Richey, Florida, United States, 34652
    • Orlando, Florida, United States, 32822
    • Panama City, Florida, United States, 32401
    • Pinellas Park, Florida, United States, 33781
    • Port Charlotte, Florida, United States, 33952
    • Sarasota, Florida, United States, 34239
    • St. Petersburg, Florida, United States, 33709
    • Tampa, Florida, United States, 33613
    • West Palm Beach, Florida, United States, 33401
    • Winter Park, Florida, United States, 32789
  • Georgia
    • Augusta, Georgia, United States, 30909
    • Decatur, Georgia, United States, 30030
    • Dunwoody, Georgia, United States, 30338
  • Idaho
    • Eagle, Idaho, United States, 83616
    • Idaho Falls, Idaho, United States, 83404
  • Illinois
    • Melrose Park, Illinois, United States, 60160
  • Indiana
    • Brownsburg, Indiana, United States, 46112
    • Evansville, Indiana, United States, 47714
    • Valparaiso, Indiana, United States, 46383
  • Iowa
    • Council Bluffs, Iowa, United States, 51501
    • Iowa City, Iowa, United States, 52242
  • Kansas
    • Wichita, Kansas, United States, 67203
  • Kentucky
    • Lexington, Kentucky, United States, 40504
    • Louisville, Kentucky, United States, 40213
    • Owensboro, Kentucky, United States, 42303
  • Louisiana
    • Alexandria, Louisiana, United States, 71301
  • Maine
    • Bangor, Maine, United States, 04401
  • Maryland
    • Baltimore, Maryland, United States, 21215
    • Baltimore, Maryland, United States, 21201
    • Baltimore, Maryland, United States, 21209
    • Oxon Hill, Maryland, United States, 20745
  • Massachusetts
    • Haverhill, Massachusetts, United States, 01830
  • Michigan
    • Traverse City, Michigan, United States, 49684
  • Mississippi
    • Fall Rivers, Mississippi, United States, 02720
  • Missouri
    • Kansas City, Missouri, United States, 64111
  • Nebraska
    • Bellevue, Nebraska, United States, 68005
    • Fremont, Nebraska, United States, 68025
  • Nevada
    • Las Vegas, Nevada, United States, 89106
    • Las Vegas, Nevada, United States, 89121
    • Las Vegas, Nevada, United States, 89123
  • New Jersey
    • Elizabeth, New Jersey, United States, 07202
  • New York
    • Albany, New York, United States, 12206-1098
    • North Massapequa, New York, United States, 11758
    • Smithtown, New York, United States, 11787
    • Syracuse, New York, United States, 13202
    • Westfield, New York, United States, 14787
  • North Carolina
    • Elizabeth City, North Carolina, United States, 27909
    • Morganton, North Carolina, United States, 28655
    • Raleigh, North Carolina, United States, 27609
    • Shelby, North Carolina, United States, 28150
    • Winston-Salem, North Carolina, United States, 27103
  • North Dakota
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Akron, Ohio, United States, 44313
    • Gallipolis, Ohio, United States, 45631
    • Kettering, Ohio, United States, 45429
    • Zanesville, Ohio, United States, 43701
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
    • Tulsa, Oklahoma, United States, 74104
  • Oregon
    • Portland, Oregon, United States, 97220
  • Pennsylvania
    • Beaver, Pennsylvania, United States, 15009
    • Doylestown, Pennsylvania, United States, 18901
    • Fleetwood, Pennsylvania, United States, 19522
    • Harleysville, Pennsylvania, United States, 19438
    • Jersey Shore, Pennsylvania, United States, 17740
    • Lansdale, Pennsylvania, United States, 19446
    • Philadelphia, Pennsylvania, United States, 19114
    • Pittsburg, Pennsylvania, United States, 15202
    • Sellersville, Pennsylvania, United States, 18960
    • Uniontown, Pennsylvania, United States, 15401
  • South Carolina
    • Clinton, South Carolina, United States, 29325
    • Greer, South Carolina, United States, 29651
    • Murrells Inlet, South Carolina, United States, 29576
    • Varnville, South Carolina, United States, 29944
  • South Dakota
    • Dakota Dunes, South Dakota, United States, 57049
  • Tennessee
    • Chattanooga, Tennessee, United States, 37404-3230
    • Chattanooga, Tennessee, United States, 37411
    • Jackson, Tennessee, United States, 38305
    • Knoxville, Tennessee, United States, 27912
    • Nashville, Tennessee, United States, 37203
  • Texas
    • Arlington, Texas, United States, 76012
    • Corpus Christi, Texas, United States, 78404
    • Dallas, Texas, United States, 75230
    • El Paso, Texas, United States, 79925
    • Houston, Texas, United States, 77030
    • Houston, Texas, United States, 77074
    • Houston, Texas, United States, 77036
    • Kingwood, Texas, United States, 77339
    • McAllen, Texas, United States, 78501
    • New Braunfels, Texas, United States, 78130
    • North Richland Hills, Texas, United States, 76180
    • San Antonio, Texas, United States, 78229
    • San Antonio, Texas, United States, 78224
    • Tyler, Texas, United States, 75701
  • Utah
    • Bountiful, Utah, United States, 84010
    • Draper, Utah, United States, 84020
    • Murray, Utah, United States, 84123
    • Salt Lake City, Utah, United States, 84124
  • Virginia
    • Burke, Virginia, United States, 22015
    • Manassas, Virginia, United States, 20110
    • Suffolk, Virginia, United States, 23435
  • Washington
    • Port Orchard, Washington, United States, 98366
    • Spokane, Washington, United States, 99207
  • Wisconsin
    • Madison, Wisconsin, United States, 53719

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male and female patients with established evidence of stable cardiovascular disease (CVD) defined as at least one of the following groups of criteria (A or B) A. Age >/= 40 years with history with prior CV event of prior myocardial infarction or prior ischemic stroke (confirmed by brain imaging study), with onset >/= 3 months prior to randomization and stable in the Investigator's judgment B. Age >/= 55 years with evidence of CVD (stable in the Investigator's judgment), defined as at least one of the following: Coronary disease, cerebrovascular disease or peripheral arterial disease as defined by protocol
• Patients with glucose abnormalities based on one of the following A-B criteria:

A. Established Type 2 diabetes mellitus (T2D) according to 2010 ADA criteria; treatment may include diet alone, or any glucose-lowering therapies except for thiazolidinediones (TDZs) B. No fulfillment of criterion A) but evidence of glucose abnormalities

• Optimal management of CV risk factors including hypertension and dyslipidemia as informed by the best evidence and clinical practice guidelines

Exclusion Criteria:

• Current treatment with a thiazolidinedione (TDZ) or fibrate
• Prior intolerance to a TDZ or fibrate
• Previous participation in a trial with aleglitazar
• Other types of diabetes
• Inadequate liver, hematologic or renal function
• Symptomatic heart failure classified as NYHA class II-IV
• Hospitalization for a primary diagnosis of heart failure in the 12-month period preceding randomization
• Peripheral edema which in the judgment of the Investigator in believed to be severe and of cardiac origin
• History of surgical coronary revascularization (CABG) less than 5 years prior to screening, except in cases of subsequent myocardial infarction
• Currently scheduled for arterial revascularization procedures
• Systemic corticosteroid therapy for > 2 weeks within 3 months prior to screening
• Diagnosed or treated malignancy (except for treated basal cell skin cancer, in situ carcinoma of the cervix, or in situ prostate cancer) within the past 5 years

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo; matching aleglitazar placebo tablet orally daily
Experimental: Aleglitazar	Drug: aleglitazar; 150 mcg orally daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of any component of the composite event (cardiovascular death, non-fatal myocardial infarction (MI), non-fatal stroke) as adjudicated by the Clinical Events Committee (CEC)	5 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Time to first occurrence of a composite with components as adjudicated by the CEC: cardiovascular death, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)	5 years
Time to first occurrence of a composite with components as adjudicated by the CEC: all-cause mortality, non-fatal MI and non-fatal stroke (in each of the subgroups with or without evidence of T2D at baseline)	5 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: October 25, 2012
• First Submitted That Met QC Criteria: October 25, 2012
• First Posted (Estimate): October 29, 2012

Study Record Updates

• Last Update Posted (Estimate): November 2, 2016
• Last Update Submitted That Met QC Criteria: November 1, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Cardiovascular Diseases; Diabetes Mellitus, Type 2
• Other Study ID Numbers: BC28027; 2012-000671-16 (EudraCT Number)