A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01018173
Recruitment Status : Completed
First Posted : November 23, 2009
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

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

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 :
  1. 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 :
  1. Secondary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ]
  2. Individual components of primary cardiovascular composite endpoints [ Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter ]
  3. Total mortality [ Time Frame: assessed at end of study, week 104 ]
  4. 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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier (NCT number): NCT01018173

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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
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Centennial, Colorado, United States, 80112
Colorado Springs, Colorado, United States, 80907
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Trumbull, Connecticut, United States, 06611
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Washington, District of Columbia, United States, 20010
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Clearwater, Florida, United States, 33765
Delray Beach, Florida, United States, 33446
Jacksonville, Florida, United States, 32216
Miami, Florida, United States, 33126
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Evansville, Indiana, United States, 47714
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Baltimore, Maryland, United States, 21204
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Jackson, Mississippi, United States, 39202
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Saint Louis, Missouri, United States, 63141
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North Platte, Nebraska, United States, 69101
Omaha, Nebraska, United States, 68131
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Las Vegas, Nevada, United States, 89101
Las Vegas, Nevada, United States, 89104
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Nashua, New Hampshire, United States, 3063
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Toms River, New Jersey, United States, 08753
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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
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Raleigh, North Carolina, United States, 27607
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Bismarck, North Dakota, United States, 58501
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Cleveland, Ohio, United States, 44122
Kettering, Ohio, United States, 45429
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Bend, Oregon, United States, 97701
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Beaver, Pennsylvania, United States, 15009
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Greer, South Carolina, United States, 29651
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Bristol, Tennessee, United States, 37620
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Austin, Texas, United States, 78705
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Houston, Texas, United States, 77070
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Temple, Texas, United States, 76508
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Salt Lake City, Utah, United States, 84107
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Burke, Virginia, United States, 22015
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Norfolk, Virginia, United States, 23502
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Winchester, Virginia, United States, 22601
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Tacoma, Washington, United States, 98405
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Freemantle, Queensland, Australia, 6959
Herston, Queensland, Australia, 4029
Australia, South Australia
Elizabeth Vale, South Australia, Australia, 5112
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Melbourne, Victoria, Australia, 3004
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Fortaleza, CE, Brazil, 60430-370
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Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1142
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Varna, Bulgaria, 9000
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Barrie, Ontario, Canada, L4M 7G1
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Montreal, Quebec, Canada, H2W 1T8
Sherbrooke, Quebec, Canada, J1G 5K2
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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
Aalborg, Denmark, 9000
Ballerup, Denmark, 2750
Hvidovre, Denmark, 2650
Vejle, Denmark, 7100
Paide, Estonia, 72714
Saku, Estonia, 75501
Tallinn, Estonia, 10128
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Tallinn, Estonia, 13419
Tartu, Estonia, 50410
Tartu, Estonia, 51010
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Voru, Estonia, 65608
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
Balatonfuered, Hungary, 8230
Budapest, Hungary, 1036
Budapest, Hungary, 1095
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Debrecen, Hungary, 4025
Gyula, Hungary, 5700
Hodmezovasarhely, Hungary, 6800
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Mako, Hungary, 6900
Sopron, Hungary, 9400
Szikszo, Hungary, 3800
Urhida, Hungary, 8142
Veszprem, Hungary, 8200
Ahmedabad, India, 382428
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Bangalore, India, 560010
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Chennai, India, 600006
Chennai, India, 600013
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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
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Pune, India, 411011
Jerusalem, Israel, 91200
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Kaunas, Lithuania, 49427
Kaunas, Lithuania, 50009
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Katowice, Poland, 40-748
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Krakow, Poland, 31-548
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Radom, Poland, 26-610
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Warszawa, Poland, 02-692
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Wroclaw, Poland, 50-088
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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
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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
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
Lugo, Spain, 27004
Madrid, Spain, 28040
Taichung, Taiwan, 404
Taipei, Taiwan, 106
Taipei, Taiwan, 111
Taipei, Taiwan, 112
Taipei, Taiwan, 114
Taoyuan County, Taiwan, 333
Bangkok, Thailand, 10330
Bangkok, Thailand, 10400
Chiang Mai, Thailand, 50200
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
Study Director: Clinical Trials Hoffmann-La Roche

Responsible Party: Hoffmann-La Roche Identifier: NCT01018173     History of Changes
Other Study ID Numbers: NC25113
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