A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
This study has been completed.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01018173
First received: November 20, 2009
Last updated: September 1, 2016
Last verified: September 2016
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Purpose
This randomized, double-blind, placebo-controlled parallel arm study will assess efficacy and safety and the effects of taspoglutide on cardiovascular events in patients with inadequately controlled type 2 diabetes mellitus and established cardiovascular disease. Patients will be randomized to receive either taspoglutide subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or weekly sc placebo, in addition to background anti-hyperglycemic medication and standard of care treatment for cardiovascular disease. Anticipated time on study treatment is up to 2 years. Target sample size is 2000 patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Type 2 |
Drug: placebo Drug: taspoglutide |
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 Randomized Double Blind, Placebo-controlled Clinical Trial to Assess the Effects of Taspoglutide (RO5073031) on Cardiovascular Outcomes in Subjects With Inadequately Controlled Type 2 Diabetes and Established Cardiovascular Disease |
Resource links provided by NLM:
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Time to cardiovascular composite primary endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Secondary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ] [ Designated as safety issue: No ]
- Individual components of primary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ] [ Designated as safety issue: No ]
- Total mortality [ Time Frame: assessed at end of study, week 104 ] [ Designated as safety issue: No ]
- Metabolic and renal function parameters: HbA1c, fasting plasma glucose, body weight, lipid profile, albumin/creatinine ratio (ACR), albuminuria, glomerular filtration rate (GFR) [ Time Frame: laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter ] [ Designated as safety issue: No ]
| Enrollment: | 2118 |
| Study Start Date: | January 2010 |
| Study Completion Date: | January 2011 |
| Primary Completion Date: | January 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: placebo |
Drug: placebo
sc weekly
|
| Experimental: taspoglutide |
Drug: taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- adult patients, >18 years of age
- diabetes mellitus type 2
- HbA1c >/=6.5% and </=10% at screening
- BMI >/=23kg/m2
- cardiovascular disease with onset >/=1 month prior to screening
Exclusion Criteria:
- diagnosis or history of type 1 diabetes or secondary forms of diabetes
- acute metabolic diabetic complications within past 6 months
- severe hypoglycemia </=1 month prior to screening
- clinically significant gastrointestinal disease
- history of chronic or acute pancreatitis
- current New York Heart Association (NYHA) class IV heart failure or post-transplantation cardiomyopathy
- severely impaired renal function
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01018173
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01018173
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Locations
| United States, Arizona | |
| Phoenix, Arizona, United States, 85050 | |
| Tucson, Arizona, United States, 85741 | |
| United States, California | |
| Buena Park, California, United States, 90620 | |
| Calabasas, California, United States, 91302 | |
| Fresno, California, United States, 93720 | |
| Santa Ana, California, United States, 92705 | |
| Walnut Creek, California, United States, 94598 | |
| United States, Colorado | |
| Centennial, Colorado, United States, 80112 | |
| Colorado Springs, Colorado, United States, 80907 | |
| United States, Connecticut | |
| Trumbull, Connecticut, United States, 06611 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20010 | |
| United States, Florida | |
| Clearwater, Florida, United States, 33765 | |
| Delray Beach, Florida, United States, 33446 | |
| Jacksonville, Florida, United States, 32216 | |
| Miami, Florida, United States, 33126 | |
| Ponte Verde, Florida, United States, 32081 | |
| United States, Illinois | |
| Bloomingdale, Illinois, United States, 60108 | |
| Chicago, Illinois, United States, 60607 | |
| Chicago, Illinois, United States, 60610 | |
| United States, Indiana | |
| Evansville, Indiana, United States, 47714 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21204 | |
| Oxon Hill, Maryland, United States, 20745 | |
| United States, Mississippi | |
| Jackson, Mississippi, United States, 39202 | |
| United States, Missouri | |
| Saint Louis, Missouri, United States, 63141 | |
| United States, Nebraska | |
| North Platte, Nebraska, United States, 69101 | |
| Omaha, Nebraska, United States, 68131 | |
| United States, Nevada | |
| Las Vegas, Nevada, United States, 89101 | |
| Las Vegas, Nevada, United States, 89104 | |
| United States, New Hampshire | |
| Nashua, New Hampshire, United States, 3063 | |
| United States, New Jersey | |
| Toms River, New Jersey, United States, 08753 | |
| United States, New York | |
| Mineola, New York, United States, 11501 | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Calabash, North Carolina, United States, 28467 | |
| Cary, North Carolina, United States, 27518 | |
| Chapel Hill, North Carolina, United States, 27514 | |
| Charlotte, North Carolina, United States, 28209 | |
| Durham, North Carolina, United States, 27713 | |
| Mooresville, North Carolina, United States, 28117 | |
| Raleigh, North Carolina, United States, 27607 | |
| United States, North Dakota | |
| Bismarck, North Dakota, United States, 58501 | |
| Bismark, North Dakota, United States, 58507 | |
| United States, Ohio | |
| Cleveland, Ohio, United States, 44122 | |
| Kettering, Ohio, United States, 45429 | |
| Toledo, Ohio, United States, 43623 | |
| United States, Oregon | |
| Bend, Oregon, United States, 97701 | |
| Medford, Oregon, United States, 97504 | |
| Portland, Oregon, United States, 97229 | |
| United States, Pennsylvania | |
| Beaver, Pennsylvania, United States, 15009 | |
| Levittown, Pennsylvania, United States, 19056 | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pottstown, Pennsylvania, United States, 19464 | |
| United States, South Carolina | |
| Greer, South Carolina, United States, 29651 | |
| Hickory, South Carolina, United States, 28602 | |
| United States, Tennessee | |
| Bristol, Tennessee, United States, 37620 | |
| Johnson City, Tennessee, United States, 37604 | |
| United States, Texas | |
| Austin, Texas, United States, 78705 | |
| Carrollton, Texas, United States, 75010 | |
| Dallas, Texas, United States, 75220 | |
| Dallas, Texas, United States, 75230 | |
| Dallas, Texas, United States, 75246 | |
| Fort Worth, Texas, United States, 76109 | |
| Houston, Texas, United States, 77070 | |
| Irving, Texas, United States, 75039 | |
| North Richland Hills, Texas, United States, 76180 | |
| Richardson, Texas, United States, 75080 | |
| San Antonio, Texas, United States, 78229-4801 | |
| San Antonio, Texas, United States, 78229 | |
| Temple, Texas, United States, 76508 | |
| United States, Utah | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Virginia | |
| Burke, Virginia, United States, 22015 | |
| Hampton, Virginia, United States, 23666 | |
| Manassas, Virginia, United States, 20110 | |
| Norfolk, Virginia, United States, 23502 | |
| Richmond, Virginia, United States, 23219 | |
| Winchester, Virginia, United States, 22601 | |
| United States, Washington | |
| Tacoma, Washington, United States, 98405 | |
| Australia, Queensland | |
| Freemantle, Queensland, Australia, 6959 | |
| Herston, Queensland, Australia, 4029 | |
| Australia, South Australia | |
| Elizabeth Vale, South Australia, Australia, 5112 | |
| Australia, Victoria | |
| Melbourne, Victoria, Australia, 3004 | |
| Brazil | |
| Fortaleza, CE, Brazil, 60135-170 | |
| Fortaleza, CE, Brazil, 60430-370 | |
| Campina Grande do Sul, PR, Brazil, 83430-000 | |
| Rio de Janeiro, RJ, Brazil, 20211340 | |
| Rio de Janeiro, RJ, Brazil, 22271-100 | |
| Sao Paulo, SP, Brazil, 01244-030 | |
| Sao Paulo, SP, Brazil, 04020-050 | |
| Sao Paulo, SP, Brazil, 04022-001 | |
| Sao Paulo, SP, Brazil, 04266-010 | |
| Sao Paulo, SP, Brazil, 05437-010 | |
| Bulgaria | |
| Byala, Bulgaria, 7100 | |
| Pleven, Bulgaria, 5800 | |
| Plovdiv, Bulgaria, 4002 | |
| Sofia, Bulgaria, 1142 | |
| Sofia, Bulgaria, 1233 | |
| Varna, Bulgaria, 9000 | |
| Canada, Ontario | |
| Barrie, Ontario, Canada, L4M 7G1 | |
| Toronto, Ontario, Canada, M4G 3E8 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H2W 1T8 | |
| Sherbrooke, Quebec, Canada, J1G 5K2 | |
| Czech Republic | |
| Havirov, Czech Republic, 76301 | |
| Jindrichuv Hradec, Czech Republic, 377 38 | |
| Marianske Lazne, Czech Republic, 353 01 | |
| Olomouc, Czech Republic, 779 00 | |
| Pardubice, Czech Republic, 530 02 | |
| Praha, Czech Republic, 180 00 | |
| Rakovnik, Czech Republic, 269 01 | |
| Ricany u Prahy, Czech Republic, 250 01 | |
| Semily, Czech Republic, 513 31 | |
| Trutnov, Czech Republic, 541 01 | |
| Uherske Hradiste, Czech Republic, 686 06 | |
| Usti nad Labem, Czech Republic, 400 11 | |
| Denmark | |
| Aalborg, Denmark, 9000 | |
| Ballerup, Denmark, 2750 | |
| Hvidovre, Denmark, 2650 | |
| Vejle, Denmark, 7100 | |
| Estonia | |
| Paide, Estonia, 72714 | |
| Saku, Estonia, 75501 | |
| Tallinn, Estonia, 10128 | |
| Tallinn, Estonia, 11911 | |
| Tallinn, Estonia, 13415 | |
| Tallinn, Estonia, 13419 | |
| Tartu, Estonia, 50410 | |
| Tartu, Estonia, 51010 | |
| Viljandimaa, Estonia, 71024 | |
| Voru, Estonia, 65608 | |
| Germany | |
| Bad Lauterberg, Germany, 37431 | |
| Bad Oeynhausen, Germany, 32545 | |
| Bochum, Germany, 44789 | |
| Dortmund, Germany, 44137 | |
| Dresden, Germany, 01307 | |
| Essen, Germany, 45359 | |
| Hamburg, Germany, 22607 | |
| Kleve, Germany, 47533 | |
| Neuss, Germany, 41460 | |
| Nürnberg, Germany, 90402 | |
| Wuppertal, Germany, 42117 | |
| Hungary | |
| Balatonfuered, Hungary, 8230 | |
| Budapest, Hungary, 1036 | |
| Budapest, Hungary, 1095 | |
| Budapest, Hungary, 1096 | |
| Debrecen, Hungary, 4025 | |
| Gyula, Hungary, 5700 | |
| Hodmezovasarhely, Hungary, 6800 | |
| Komarom, Hungary, 2921 | |
| Mako, Hungary, 6900 | |
| Sopron, Hungary, 9400 | |
| Szikszo, Hungary, 3800 | |
| Urhida, Hungary, 8142 | |
| Veszprem, Hungary, 8200 | |
| India | |
| Ahmedabad, India, 382428 | |
| Aurangabad, India, 431005 | |
| Bangalore, India, 560003 | |
| Bangalore, India, 560010 | |
| Bangalore, India, 560052 | |
| Bangalore, India, 560078 | |
| Banglore, India, 560034 | |
| Bhopal, India, 462003 | |
| Chennai, India, 600006 | |
| Chennai, India, 600013 | |
| Chennai, India, 600086 | |
| Cochin, India, 682026 | |
| Hyderabad, India, 500 033 | |
| Jaipur, India, 302001 | |
| Kolkata, India, 700053 | |
| Madurai, India, 625020 | |
| Mangalore, India, 575001 | |
| Mumbai, India, 400007 | |
| Mumbai, India, 400012 | |
| Nagpur, India, 440010 | |
| Nagpur, India, 440012 | |
| Pune, India, 411 001 | |
| Pune, India, 411004 | |
| Pune, India, 411011 | |
| Israel | |
| Jerusalem, Israel, 91200 | |
| Lithuania | |
| Alytus, Lithuania, 62381 | |
| Kaunas, Lithuania, 49427 | |
| Kaunas, Lithuania, 50009 | |
| Kaunas, Lithuania, 51270 | |
| Kaunas, Lithuania, LT-48426 | |
| Klaipeda, Lithuania, 92304 | |
| Panevezys, Lithuania, 35144 | |
| Vilnius, Lithuania, 04318 | |
| Vilnius, Lithuania, 08661 | |
| Malaysia | |
| Johor, Malaysia, 80100 | |
| Kelantan, Malaysia, 16150 | |
| Penang, Malaysia, 10450 | |
| Mexico | |
| Aguascalientes, Mexico, 20127 | |
| Chihuahua, Mexico, 31238 | |
| Cuernavaca, Mexico, 62250 | |
| Culiacan, Mexico, 80020 | |
| Durango, Mexico, 34000 | |
| Juarez, Distrito Federal, Mexico, 6600 | |
| Mexico City, Mexico, 14000 | |
| Mexico, Mexico, 06100 | |
| Monterrey, Mexico, 64460 | |
| Tampico, Mexico, 89000 | |
| Poland | |
| Gdansk, Poland, 80-858 | |
| Gdynia, Poland, 81-384 | |
| Kamieniec Zabkowicki, Poland, 57-230 | |
| Katowice, Poland, 40-748 | |
| Kielce, Poland, 25-315 | |
| Krakow, Poland, 31-261 | |
| Krakow, Poland, 31-548 | |
| Lodz, Poland, 94-060 | |
| Plock, Poland, 09-402 | |
| Poznan, Poland, 61-655 | |
| Radom, Poland, 26-610 | |
| Warszawa, Poland, 01-231 | |
| Warszawa, Poland, 02-692 | |
| Warszawa, Poland, 04-730 | |
| Wroclaw, Poland, 50-088 | |
| Romania | |
| Bacau, Romania, 600114 | |
| Baia Mare, Romania, 430123 | |
| Bucharest, Romania, 011794 | |
| Bucharest, Romania, 020475 | |
| Bucharest, Romania, 10507 | |
| Bucuresti, Romania, 20475 | |
| Constanta, Romania, 900591 | |
| Galati, Romania, 800371 | |
| Oradea, Romania, 410169 | |
| Ploiesti, Romania, 100097 | |
| Ploiesti, Romania, 100342 | |
| Targu Mures, Romania, 540142 | |
| Timisoara, Romania, 300456 | |
| Russian Federation | |
| Barnaul, Russian Federation, 656055 | |
| Kemerovo, Russian Federation, 650099 | |
| Moscow, Russian Federation, 125299 | |
| Novosibirsk, Russian Federation, 630090 | |
| S. Petersburg, Russian Federation, 194291 | |
| St. Petersburg, Russian Federation, 193318 | |
| St. Petersburg, Russian Federation, 197706 | |
| Slovakia | |
| Banska Bystrica, Slovakia, 975 17 | |
| Bratislava, Slovakia, 813 69 | |
| Bratislava, Slovakia, 821 02 | |
| Bratislava, Slovakia, 82108 | |
| Dolny Kubin, Slovakia, 026 01 | |
| Komarno, Slovakia, 94501 | |
| Levice, Slovakia, 93405 | |
| Levice, Slovakia, 95401 | |
| Lucenec, Slovakia, 98401 | |
| Prievidza, Slovakia, 97101 | |
| Trencin, Slovakia, 911 01 | |
| South Africa | |
| Cape Town, South Africa, 7130 | |
| Cape Town, South Africa, 7505 | |
| Durban, South Africa, 4091 | |
| Johannesburg, South Africa, 1619 | |
| Johannesburg, South Africa, 2113 | |
| Observatory, Cape Town, South Africa, 7925 | |
| Port Elizabeth, South Africa, 6014 | |
| Pretoria, South Africa, 0112 | |
| Pretoria, South Africa, 0184 | |
| Richards Bay, South Africa, 3900 | |
| Soweto, South Africa, 1818 | |
| Soweto, South Africa, 2013 | |
| Spain | |
| Lugo, Spain, 27004 | |
| Madrid, Spain, 28040 | |
| Taiwan | |
| Taichung, Taiwan, 404 | |
| Taipei, Taiwan, 106 | |
| Taipei, Taiwan, 111 | |
| Taipei, Taiwan, 112 | |
| Taipei, Taiwan, 114 | |
| Taoyuan County, Taiwan, 333 | |
| Thailand | |
| Bangkok, Thailand, 10330 | |
| Bangkok, Thailand, 10400 | |
| Chiang Mai, Thailand, 50200 | |
| Ukraine | |
| Kharkiv, Ukraine, 61022 | |
| Kiev, Ukraine, 02175 | |
| Kiev, Ukraine, 1004 | |
| Lviv, Ukraine, 79010 | |
| Mykolaiv, Ukraine, 54003 | |
| Poltava, Ukraine, 36024 | |
| Ternopil, Ukraine, 46002 | |
| Vinnitsa, Ukraine, 21010 | |
| Zaporizhzhya, Ukraine, 69001 | |
| Zaporizhzhya, Ukraine, 69035 | |
| United Kingdom | |
| Bexhill on Sea, United Kingdom, TN39 4SP | |
| Birmingham, United Kingdom, B15 2SQ | |
| Cardiff, United Kingdom, CF14 5GJ | |
| Chorley, United Kingdom, PR7 7NA | |
| Dundee, United Kingdom, DD1 9SY | |
| Glasgow, United Kingdom, G20 0SP | |
| Liverpool, United Kingdom, L22 0LG | |
| Liverpool, United Kingdom, L7 8XP | |
| London, United Kingdom, E1 2ES | |
| Manchester, United Kingdom, M15 6SX | |
| Reading, United Kingdom, RG2 7AG | |
| Salford, United Kingdom, M6 8HD | |
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
| Study Director: | Clinical Trials | Hoffmann-La Roche |
More Information
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01018173 History of Changes |
| Other Study ID Numbers: | NC25113 2009-014986-22 |
| Study First Received: | November 20, 2009 |
| 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