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Clinical Trial Details

Trial ID:	L1938
Source ID:	NCT01018173
Associated Drug:	Placebo
Title:	A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
Acronym:
Status:	COMPLETED
Study Results:	NO
Results:
Conditions:	Diabetes Mellitus Type 2
Interventions:	DRUG: placebo\|DRUG: taspoglutide
Outcome Measures:	Primary: Time to cardiovascular composite primary endpoints, event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter \| Secondary: Secondary cardiovascular composite endpoints, event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter\|Individual components of primary cardiovascular composite endpoints, event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter\|Total mortality, assessed at end of study, week 104\|Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR), laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter
Sponsor/Collaborators:	Sponsor: Hoffmann-La Roche
Gender:	ALL
Age:	ADULT, OLDER_ADULT
Phases:	PHASE3
Enrollment:	2118
Study Type:	INTERVENTIONAL
Study Designs:	Allocation: RANDOMIZED\|Intervention Model: PARALLEL\|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)\|Primary Purpose: TREATMENT
Start Date:	2010-01
Completion Date:	2011-01
Results First Posted:
Last Update Posted:	2016-11-02
Locations:	Phoenix, Arizona, 85050, United States\|Tucson, Arizona, 85741, United States\|Buena Park, California, 90620, United States\|Calabasas, California, 91302, United States\|Fresno, California, 93720, United States\|Santa Ana, California, 92705, United States\|Walnut Creek, California, 94598, United States\|Centennial, Colorado, 80112, United States\|Colorado Springs, Colorado, 80907, United States\|Trumbull, Connecticut, 06611, United States\|Washington, District of Columbia, 20010, United States\|Clearwater, Florida, 33765, United States\|Delray Beach, Florida, 33446, United States\|Jacksonville, Florida, 32216, United States\|Miami, Florida, 33126, United States\|Ponte Verde, Florida, 32081, United States\|Bloomingdale, Illinois, 60108, United States\|Chicago, Illinois, 60607, United States\|Chicago, Illinois, 60610, United States\|Evansville, Indiana, 47714, United States\|Baltimore, Maryland, 21204, United States\|Oxon Hill, Maryland, 20745, United States\|Jackson, Mississippi, 39202, United States\|Saint Louis, Missouri, 63141, United States\|North Platte, Nebraska, 69101, United States\|Omaha, Nebraska, 68131, United States\|Las Vegas, Nevada, 89101, United States\|Las Vegas, Nevada, 89104, United States\|Nashua, New Hampshire, 3063, United States\|Toms River, New Jersey, 08753, United States\|Mineola, New York, 11501, United States\|New York, New York, 10032, United States\|Calabash, North Carolina, 28467, United States\|Cary, North Carolina, 27518, United States\|Chapel Hill, North Carolina, 27514, United States\|Charlotte, North Carolina, 28209, United States\|Durham, North Carolina, 27713, United States\|Mooresville, North Carolina, 28117, United States\|Raleigh, North Carolina, 27607, United States\|Bismarck, North Dakota, 58501, United States\|Bismark, North Dakota, 58507, United States\|Cleveland, Ohio, 44122, United States\|Kettering, Ohio, 45429, United States\|Toledo, Ohio, 43623, United States\|Bend, Oregon, 97701, United States\|Medford, Oregon, 97504, United States\|Portland, Oregon, 97229, United States\|Beaver, Pennsylvania, 15009, United States\|Levittown, Pennsylvania, 19056, United States\|Philadelphia, Pennsylvania, 19140, United States\|Pottstown, Pennsylvania, 19464, United States\|Greer, South Carolina, 29651, United States\|Hickory, South Carolina, 28602, United States\|Bristol, Tennessee, 37620, United States\|Johnson City, Tennessee, 37604, United States\|Austin, Texas, 78705, United States\|Carrollton, Texas, 75010, United States\|Dallas, Texas, 75220, United States\|Dallas, Texas, 75230, United States\|Dallas, Texas, 75246, United States\|Fort Worth, Texas, 76109, United States\|Houston, Texas, 77070, United States\|Irving, Texas, 75039, United States\|North Richland Hills, Texas, 76180, United States\|Richardson, Texas, 75080, United States\|San Antonio, Texas, 78229-4801, United States\|San Antonio, Texas, 78229, United States\|Temple, Texas, 76508, United States\|Salt Lake City, Utah, 84107, United States\|Burke, Virginia, 22015, United States\|Hampton, Virginia, 23666, United States\|Manassas, Virginia, 20110, United States\|Norfolk, Virginia, 23502, United States\|Richmond, Virginia, 23219, United States\|Winchester, Virginia, 22601, United States\|Tacoma, Washington, 98405, United States\|Freemantle, Queensland, 6959, Australia\|Herston, Queensland, 4029, Australia\|Elizabeth Vale, South Australia, 5112, Australia\|Melbourne, Victoria, 3004, Australia\|Fortaleza, CE, 60135-170, Brazil\|Fortaleza, CE, 60430-370, Brazil\|Campina Grande do Sul, PR, 83430-000, Brazil\|Rio de Janeiro, RJ, 20211340, Brazil\|Rio de Janeiro, RJ, 22271-100, Brazil\|Sao Paulo, SP, 01244-030, Brazil\|Sao Paulo, SP, 04020-050, Brazil\|Sao Paulo, SP, 04022-001, Brazil\|Sao Paulo, SP, 04266-010, Brazil\|Sao Paulo, SP, 05437-010, Brazil\|Byala, 7100, Bulgaria\|Pleven, 5800, Bulgaria\|Plovdiv, 4002, Bulgaria\|Sofia, 1142, Bulgaria\|Sofia, 1233, Bulgaria\|Varna, 9000, Bulgaria\|Barrie, Ontario, L4M 7G1, Canada\|Toronto, Ontario, M4G 3E8, Canada\|Montreal, Quebec, H2W 1T8, Canada\|Sherbrooke, Quebec, J1G 5K2, Canada\|Havirov, 76301, Czech Republic\|Jindrichuv Hradec, 377 38, Czech Republic\|Marianske Lazne, 353 01, Czech Republic\|Olomouc, 779 00, Czech Republic\|Pardubice, 530 02, Czech Republic\|Praha, 180 00, Czech Republic\|Rakovnik, 269 01, Czech Republic\|Ricany u Prahy, 250 01, Czech Republic\|Semily, 513 31, Czech Republic\|Trutnov, 541 01, Czech Republic\|Uherske Hradiste, 686 06, Czech Republic\|Usti nad Labem, 400 11, Czech Republic\|Aalborg, 9000, Denmark\|Ballerup, 2750, Denmark\|Hvidovre, 2650, Denmark\|Vejle, 7100, Denmark\|Paide, 72714, Estonia\|Saku, 75501, Estonia\|Tallinn, 10128, Estonia\|Tallinn, 11911, Estonia\|Tallinn, 13415, Estonia\|Tallinn, 13419, Estonia\|Tartu, 50410, Estonia\|Tartu, 51010, Estonia\|Viljandimaa, 71024, Estonia\|Voru, 65608, Estonia\|Bad Lauterberg, 37431, Germany\|Bad Oeynhausen, 32545, Germany\|Bochum, 44789, Germany\|Dortmund, 44137, Germany\|Dresden, 01307, Germany\|Essen, 45359, Germany\|Hamburg, 22607, Germany\|Kleve, 47533, Germany\|Neuss, 41460, Germany\|Nürnberg, 90402, Germany\|Wuppertal, 42117, Germany\|Balatonfuered, 8230, Hungary\|Budapest, 1036, Hungary\|Budapest, 1095, Hungary\|Budapest, 1096, Hungary\|Debrecen, 4025, Hungary\|Gyula, 5700, Hungary\|Hodmezovasarhely, 6800, Hungary\|Komarom, 2921, Hungary\|Mako, 6900, Hungary\|Sopron, 9400, Hungary\|Szikszo, 3800, Hungary\|Urhida, 8142, Hungary\|Veszprem, 8200, Hungary\|Ahmedabad, 382428, India\|Aurangabad, 431005, India\|Bangalore, 560003, India\|Bangalore, 560010, India\|Bangalore, 560052, India\|Bangalore, 560078, India\|Banglore, 560034, India\|Bhopal, 462003, India\|Chennai, 600006, India\|Chennai, 600013, India\|Chennai, 600086, India\|Cochin, 682026, India\|Hyderabad, 500 033, India\|Jaipur, 302001, India\|Kolkata, 700053, India\|Madurai, 625020, India\|Mangalore, 575001, India\|Mumbai, 400007, India\|Mumbai, 400012, India\|Nagpur, 440010, India\|Nagpur, 440012, India\|Pune, 411 001, India\|Pune, 411004, India\|Pune, 411011, India\|Jerusalem, 91200, Israel\|Alytus, 62381, Lithuania\|Kaunas, 49427, Lithuania\|Kaunas, 50009, Lithuania\|Kaunas, 51270, Lithuania\|Kaunas, LT-48426, Lithuania\|Klaipeda, 92304, Lithuania\|Panevezys, 35144, Lithuania\|Vilnius, 04318, Lithuania\|Vilnius, 08661, Lithuania\|Johor, 80100, Malaysia\|Kelantan, 16150, Malaysia\|Penang, 10450, Malaysia\|Aguascalientes, 20127, Mexico\|Chihuahua, 31238, Mexico\|Cuernavaca, 62250, Mexico\|Culiacan, 80020, Mexico\|Durango, 34000, Mexico\|Juarez, Distrito Federal, 6600, Mexico\|Mexico City, 14000, Mexico\|Mexico, 06100, Mexico\|Monterrey, 64460, Mexico\|Tampico, 89000, Mexico\|Gdansk, 80-858, Poland\|Gdynia, 81-384, Poland\|Kamieniec Zabkowicki, 57-230, Poland\|Katowice, 40-748, Poland\|Kielce, 25-315, Poland\|Krakow, 31-261, Poland\|Krakow, 31-548, Poland\|Lodz, 94-060, Poland\|Plock, 09-402, Poland\|Poznan, 61-655, Poland\|Radom, 26-610, Poland\|Warszawa, 01-231, Poland\|Warszawa, 02-692, Poland\|Warszawa, 04-730, Poland\|Wroclaw, 50-088, Poland\|Bacau, 600114, Romania\|Baia Mare, 430123, Romania\|Bucharest, 011794, Romania\|Bucharest, 020475, Romania\|Bucharest, 10507, Romania\|Bucuresti, 20475, Romania\|Constanta, 900591, Romania\|Galati, 800371, Romania\|Oradea, 410169, Romania\|Ploiesti, 100097, Romania\|Ploiesti, 100342, Romania\|Targu Mures, 540142, Romania\|Timisoara, 300456, Romania\|Barnaul, 656055, Russian Federation\|Kemerovo, 650099, Russian Federation\|Moscow, 125299, Russian Federation\|Novosibirsk, 630090, Russian Federation\|S. Petersburg, 194291, Russian Federation\|St. Petersburg, 193318, Russian Federation\|St. Petersburg, 197706, Russian Federation\|Banska Bystrica, 975 17, Slovakia\|Bratislava, 813 69, Slovakia\|Bratislava, 821 02, Slovakia\|Bratislava, 82108, Slovakia\|Dolny Kubin, 026 01, Slovakia\|Komarno, 94501, Slovakia\|Levice, 93405, Slovakia\|Levice, 95401, Slovakia\|Lucenec, 98401, Slovakia\|Prievidza, 97101, Slovakia\|Trencin, 911 01, Slovakia\|Cape Town, 7130, South Africa\|Cape Town, 7505, South Africa\|Durban, 4091, South Africa\|Johannesburg, 1619, South Africa\|Johannesburg, 2113, South Africa\|Observatory, Cape Town, 7925, South Africa\|Port Elizabeth, 6014, South Africa\|Pretoria, 0112, South Africa\|Pretoria, 0184, South Africa\|Richards Bay, 3900, South Africa\|Soweto, 1818, South Africa\|Soweto, 2013, South Africa\|Lugo, 27004, Spain\|Madrid, 28040, Spain\|Taichung, 404, Taiwan\|Taipei, 106, Taiwan\|Taipei, 111, Taiwan\|Taipei, 112, Taiwan\|Taipei, 114, Taiwan\|Taoyuan County, 333, Taiwan\|Bangkok, 10330, Thailand\|Bangkok, 10400, Thailand\|Chiang Mai, 50200, Thailand\|Kharkiv, 61022, Ukraine\|Kiev, 02175, Ukraine\|Kiev, 1004, Ukraine\|Lviv, 79010, Ukraine\|Mykolaiv, 54003, Ukraine\|Poltava, 36024, Ukraine\|Ternopil, 46002, Ukraine\|Vinnitsa, 21010, Ukraine\|Zaporizhzhya, 69001, Ukraine\|Zaporizhzhya, 69035, Ukraine\|Bexhill on Sea, TN39 4SP, United Kingdom\|Birmingham, B15 2SQ, United Kingdom\|Cardiff, CF14 5GJ, United Kingdom\|Chorley, PR7 7NA, United Kingdom\|Dundee, DD1 9SY, United Kingdom\|Glasgow, G20 0SP, United Kingdom\|Liverpool, L22 0LG, United Kingdom\|Liverpool, L7 8XP, United Kingdom\|London, E1 2ES, United Kingdom\|Manchester, M15 6SX, United Kingdom\|Reading, RG2 7AG, United Kingdom\|Salford, M6 8HD, United Kingdom
URL:	https://clinicaltrials.gov/show/NCT01018173

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Associated Data

Drug ID	Drug Name	Type	DrugBank ID	Targets	Category	Latest Progress

Clinical Trial Details

Summary

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Associated Data

Associated NAFLD Drugs (0)