A Study on The Potential of Aleglitazar to Reduce Cardiovascular Risk in Patients With Stable Cardiovascular Disease and Glucose Abnormalities
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01715818
First received: October 25, 2012
Last updated: September 1, 2016
Last verified: September 2016
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Cardiovascular Disease, Diabetes Mellitus Type 2 |
Drug: Placebo Drug: aleglitazar |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | A PHASE 3B STUDY TO EVALUATE THE POTENTIAL OF ALEGLITAZAR TO REDUCE CARDIOVASCULAR RISK IN PATIENTS WITH STABLE CARDIOVASCULAR DISEASE AND GLUCOSE ABNORMALITIES |
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- 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) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
- 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) [ Time Frame: 5 years ] [ Designated as safety issue: No ]
| Enrollment: | 1999 |
| Study Start Date: | December 2012 |
| Study Completion Date: | November 2013 |
| Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Aleglitazar |
Drug: aleglitazar
150 mcg orally daily
|
| Placebo Comparator: Placebo |
Drug: Placebo
matching aleglitazar placebo tablet orally daily
|
Eligibility| Ages Eligible for Study: | 40 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715818
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01715818
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Locations
| United States, Alabama | |
| Muscle Shoals, Alabama, United States, 35662 | |
| United States, Arizona | |
| Gilbert, Arizona, United States, 85295 | |
| Phoenix, Arizona, United States, 85018 | |
| Tucson, Arizona, United States, 85724 | |
| United States, 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, 90017 | |
| Los Angeles, California, United States, 90036 | |
| 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 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80209 | |
| United States, Florida | |
| Atlantis, Florida, United States, 33462 | |
| Bradenton, Florida, United States, 34208 | |
| Brooksville, Florida, United States, 34601 | |
| Clearwater, Florida, United States, 33755 | |
| Clearwater, Florida, United States, 33756 | |
| 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 Beach, Florida, United States, 33140 | |
| Miami, Florida, United States, 33135 | |
| Miami, Florida, United States, 33144 | |
| 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 | |
| United States, Georgia | |
| Augusta, Georgia, United States, 30909 | |
| Decatur, Georgia, United States, 30030 | |
| Dunwoody, Georgia, United States, 30338 | |
| United States, Idaho | |
| Eagle, Idaho, United States, 83616 | |
| Idaho Falls, Idaho, United States, 83404 | |
| United States, Illinois | |
| Melrose Park, Illinois, United States, 60160 | |
| United States, Indiana | |
| Brownsburg, Indiana, United States, 46112 | |
| Evansville, Indiana, United States, 47714 | |
| Valparaiso, Indiana, United States, 46383 | |
| United States, Iowa | |
| Council Bluffs, Iowa, United States, 51501 | |
| Iowa City, Iowa, United States, 52242 | |
| United States, Kansas | |
| Wichita, Kansas, United States, 67203 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40504 | |
| Louisville, Kentucky, United States, 40213 | |
| Owensboro, Kentucky, United States, 42303 | |
| United States, Louisiana | |
| Alexandria, Louisiana, United States, 71301 | |
| United States, Maine | |
| Bangor, Maine, United States, 04401 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| Baltimore, Maryland, United States, 21209 | |
| Baltimore, Maryland, United States, 21215 | |
| Oxon Hill, Maryland, United States, 20745 | |
| United States, Massachusetts | |
| Haverhill, Massachusetts, United States, 01830 | |
| United States, Michigan | |
| Traverse City, Michigan, United States, 49684 | |
| United States, Mississippi | |
| Fall Rivers, Mississippi, United States, 02720 | |
| United States, Missouri | |
| Kansas City, Missouri, United States, 64111 | |
| United States, Nebraska | |
| Bellevue, Nebraska, United States, 68005 | |
| Fremont, Nebraska, United States, 68025 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89106 | |
| Las Vegas, Nevada, United States, 89121 | |
| Las Vegas, Nevada, United States, 89123 | |
| United States, New Jersey | |
| Elizabeth, New Jersey, United States, 07202 | |
| United States, 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 | |
| United States, 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 | |
| United States, North Dakota | |
| Fargo, North Dakota, United States, 58103 | |
| United States, Ohio | |
| Akron, Ohio, United States, 44313 | |
| Gallipolis, Ohio, United States, 45631 | |
| Kettering, Ohio, United States, 45429 | |
| Zanesville, Ohio, United States, 43701 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73103 | |
| Tulsa, Oklahoma, United States, 74104 | |
| United States, Oregon | |
| Portland, Oregon, United States, 97220 | |
| United States, 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 | |
| United States, 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 | |
| United States, South Dakota | |
| Dakota Dunes, South Dakota, United States, 57049 | |
| United States, 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 | |
| United States, 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, 77036 | |
| Houston, Texas, United States, 77074 | |
| 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, 78224 | |
| San Antonio, Texas, United States, 78229 | |
| Tyler, Texas, United States, 75701 | |
| United States, Utah | |
| Bountiful, Utah, United States, 84010 | |
| Draper, Utah, United States, 84020 | |
| Murray, Utah, United States, 84123 | |
| Salt Lake City, Utah, United States, 84124 | |
| United States, Virginia | |
| Burke, Virginia, United States, 22015 | |
| Manassas, Virginia, United States, 20110 | |
| Suffolk, Virginia, United States, 23435 | |
| United States, Washington | |
| Port Orchard, Washington, United States, 98366 | |
| Spokane, Washington, United States, 99207 | |
| United States, Wisconsin | |
| Madison, Wisconsin, United States, 53719 | |
| 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 | |
| Australia, Queensland | |
| South Brisbane, Queensland, Australia, 4101 | |
| Australia, South Australia | |
| Adelaide, South Australia, Australia, 5000 | |
| Woodville, South Australia, Australia, 5011 | |
| Australia, Tasmania | |
| Launceston, Tasmania, Australia, 7250 | |
| Australia, Victoria | |
| Geelong, Victoria, Australia, 3220 | |
| Heidelberg, Victoria, Australia, 3081 | |
| Melbourne, Victoria, Australia, 3004 | |
| Australia, 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, British Columbia | |
| Kelowna, British Columbia, Canada, V1Y 1E4 | |
| Surrey, British Columbia, Canada, V3V 1Z2 | |
| Canada, Manitoba | |
| Winnipeg, Manitoba, Canada, R3E 3P4 | |
| Canada, New Brunswick | |
| Bathurst, New Brunswick, Canada, E2A 4X7 | |
| Canada, 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 | |
| Canada, Prince Edward Island | |
| Quebec, Prince Edward Island, Canada, G1V 4G2 | |
| Canada, 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, H1T 3Y7 | |
| Montreal, Quebec, Canada, H2P 2M1 | |
| Montreal, Quebec, Canada, H3G 1A4 | |
| 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 | |
| Canada, Saskatchewan | |
| Saskatoon, Saskatchewan, Canada, S7K 3H3 | |
| Canada | |
| Quebec, Canada, G3K 2P8 | |
| Chile | |
| Las Condes, Chile, 7500710 | |
| Santiago, Chile, 7500010 | |
| Santiago, Chile, 7500347 | |
| Santiago, Chile, 7500710 | |
| 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, 601 77 | |
| Brno, Czech Republic, 625 00 | |
| Jihlava, Czech Republic, 586 33 | |
| Liberec, Czech Republic, 460 63 | |
| Praha 10, Czech Republic, 100 34 | |
| Praha 2, Czech Republic, 128 08 | |
| Praha 4 - Krc, Czech Republic, 140 59 | |
| Praha 4, Czech Republic, 140 21 | |
| Praha 4, Czech Republic, 140 59 | |
| Praha 4, Czech Republic, 149 00 | |
| Praha 5, Czech Republic, 150 06 | |
| Praha 5, Czech Republic, 158 00 | |
| Praha, Czech Republic, 150 30 | |
| Slany, Czech Republic, 274 51 | |
| Trebic, Czech Republic, 674 01 | |
| Estonia | |
| Narva, Estonia, 20307 | |
| Tallinn, Estonia, 10138 | |
| Tartu, Estonia, 50410 | |
| Tartu, Estonia, 51014 | |
| Germany | |
| Berlin-Charlottenburg, Germany, 14050 | |
| Berlin, Germany, 10117 | |
| Berlin, Germany, 13125 | |
| Bochum, Germany, 44787 | |
| Chemnitz, Germany, 09111 | |
| Damme, Germany, 49401 | |
| Dresden, Germany, 01067 | |
| Frankfurt, Germany, 60596 | |
| Frankfurt, Germany, 65929 | |
| 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, 1023 | |
| Budapest, Hungary, 1027 | |
| Budapest, Hungary, 1036 | |
| Budapest, Hungary, 1085 | |
| Budapest, Hungary, 1097 | |
| Budapest, Hungary, 1125 | |
| 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 | |
| Naples, Campania, Italy, 80122 | |
| Napoli, Campania, Italy, 80131 | |
| Bologna, Emilia-Romagna, Italy, 40133 | |
| Roma, Lazio, Italy, 00128 | |
| Rome, Lazio, Italy, 00185 | |
| Milano, Lombardia, Italy, 20132 | |
| Milano, Lombardia, Italy, 20138 | |
| Pavia, Lombardia, Italy, 27100 | |
| Pesaro, Marche, Italy, 61121 | |
| Catania, Sicilia, Italy, 95122 | |
| Palermo, Sicilia, Italy, 90127 | |
| Massa, Toscana, Italy, 54100 | |
| Japan | |
| Tochigi, Japan, 329-0498 | |
| Korea, Republic of | |
| Busan, Korea, Republic of, 602-715 | |
| Busan, Korea, Republic of, 602-739 | |
| Daejeon, Korea, Republic of, 35015 | |
| Gwangju, Korea, Republic of, 61469 | |
| Gyeonggi-do, Korea, Republic of, 10380 | |
| Gyeonggi-do, Korea, Republic of, 11765 | |
| Gyeonggi-do, Korea, Republic of, 410-773 | |
| Gyeonggi-Do, Korea, Republic of, 431-070 | |
| Gyeonggi-do, Korea, Republic of, 443-380 | |
| Incheon, Korea, Republic of, 405-760 | |
| Seoul, Korea, Republic of, 05030 | |
| Seoul, Korea, Republic of, 06273 | |
| Seoul, Korea, Republic of, 130-872 | |
| Seoul, Korea, Republic of, 137-701 | |
| Seoul, Korea, Republic of, 156-707 | |
| 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, 30-015 | |
| Krakow, Poland, 30-082 | |
| Krakow, Poland, 31-202 | |
| Krakow, Poland, 31-261 | |
| 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, 020359 | |
| Bucuresti, Romania, 050098 | |
| 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-West, South Africa, 0183 | |
| Pretoria, South Africa, 0103 | |
| Spain | |
| San Juan de Alicante, Alicante, Spain, 3550 | |
| Palma de Mallorca, Islas Baleares, Spain, 07014 | |
| Santiago de Compostela, La Coruña, Spain, 15706 | |
| Lleida, Lerida, Spain, 25198 | |
| Málaga, Malaga, Spain, 29009 | |
| Seville, Sevilla, Spain, 41009 | |
| Alzira, Valencia, Spain, 46600 | |
| Albacete, Spain, 02006 | |
| Almeria, Spain, 04009 | |
| Barcelona, Spain, 08003 | |
| Barcelona, Spain, 08035 | |
| Barcelona, Spain, 08036 | |
| Barcelona, Spain, 08907 | |
| Barcelona, Spain | |
| Girona, Spain, 17007 | |
| Granada, Spain, 18012 | |
| Huelva, Spain, 21005 | |
| Madrid, Spain, 41013 | |
| Malaga, Spain, 29006 | |
| Malaga, Spain, 29010 | |
| Tarragona, Spain, 43007 | |
| Valencia, Spain, 46014 | |
| Sweden | |
| Malmö, Sweden, 205 02 | |
| Stockholm, Sweden, 111 35 | |
| Stockholm, Sweden, 113 61 | |
| Stockholm, Sweden, 171 76 | |
| 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, G12 8QQ | |
| Glasgow, United Kingdom, G20 0SP | |
| Inverness, United Kingdom, IV2 4AG | |
| Liverpool, United Kingdom, L22 0LG | |
| Liverpool, United Kingdom, L9 7AL | |
| Manchester, United Kingdom, M15 6SX | |
| Mortimer, United Kingdom, RG7 3SQ | |
| Reading, United Kingdom, RG2 0TG | |
| Soham, Ely, United Kingdom, CB7 5JD | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01715818 History of Changes |
| Other Study ID Numbers: | BC28027 2012-000671-16 |
| Study First Received: | October 25, 2012 |
| Last Updated: | September 1, 2016 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus, Type 2 |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
ClinicalTrials.gov processed this record on September 23, 2016