A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
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| ClinicalTrials.gov Identifier: NCT01018173 |
|
Recruitment Status
:
Completed
First Posted
: November 23, 2009
Last Update Posted
: November 2, 2016
|
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
- Study Details
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Diabetes Mellitus Type 2 | Drug: placebo Drug: taspoglutide | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 2118 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, 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 |
| Study Start Date : | January 2010 |
| Actual Primary Completion Date : | January 2011 |
| Actual Study Completion Date : | January 2011 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Type 2 diabetes
U.S. FDA Resources
| Arm | Intervention/treatment |
|---|---|
| Placebo Comparator: placebo |
Drug: placebo
sc weekly
|
| Experimental: taspoglutide |
Drug: taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
|
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 ]
Secondary Outcome Measures
:
- Secondary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ]
- Individual components of primary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ]
- Total mortality [ Time Frame: 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) [ Time Frame: laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 |
| Responsible Party: | Hoffmann-La Roche |
| ClinicalTrials.gov Identifier: | NCT01018173 History of Changes |
| Other Study ID Numbers: |
NC25113 2009-014986-22 |
| First Posted: | November 23, 2009 Key Record Dates |
| Last Update Posted: | November 2, 2016 |
| Last Verified: | November 2016 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Cardiovascular Diseases Diabetes Mellitus, Type 2 |
Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |