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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01018173
First received: November 20, 2009
Last updated: August 26, 2014
Last verified: August 2014
  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 taspogluti de subcutaneously (sc) 10mg weekly for 4 weeks followed by 20mg sc weekly, or we ekly sc placebo, in addition to background anti-hyperglycemic medication and sta ndard of care treatment for cardiovascular disease. Anticipated time on study tr eatment 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, ACR, albuminuria, 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
Experimental: 1 Drug: taspoglutide
10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly
Placebo Comparator: 2 Drug: placebo
sc weekly

  Eligibility

Ages Eligible for Study:   18 Years and older
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 NYHA class IV heart failure or post-transplantation cardiomyopathy
  • severely impaired renal function
  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: NCT01018173

  Hide Study Locations
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, 60610
Chicago, Illinois, United States, 60607
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, 89104
Las Vegas, Nevada, United States, 89101
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, 75230
Dallas, Texas, United States, 75220
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
San Antonio, Texas, United States, 78229-4801
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, 04266-010
Sao Paulo, SP, Brazil, 04020-050
Sao Paulo, SP, Brazil, 04022-001
Sao Paulo, SP, Brazil, 01244-030
Sao Paulo, SP, Brazil, 05437-010
Bulgaria
Byala, Bulgaria, 7100
Pleven, Bulgaria, 5800
Plovdiv, Bulgaria, 4002
Sofia, Bulgaria, 1233
Sofia, Bulgaria, 1142
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, 13415
Tallinn, Estonia, 11911
Tallinn, Estonia, 13419
Tallinn, Estonia, 10128
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, 1096
Budapest, Hungary, 1036
Budapest, Hungary, 1095
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, 560078
Bangalore, India, 560010
Bangalore, India, 560003
Bangalore, India, 560052
Banglore, India, 560034
Bhopal, India, 462003
Chennai, India, 600086
Chennai, India, 600006
Chennai, India, 600013
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, LT-48426
Kaunas, Lithuania, 50009
Kaunas, Lithuania, 49427
Kaunas, Lithuania, 51270
Klaipeda, Lithuania, 92304
Panevezys, Lithuania, 35144
Vilnius, Lithuania, 08661
Vilnius, Lithuania, 04318
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, Mexico, 06100
Mexico City, Mexico, 14000
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, 31-548
Krakow, Poland, 31-261
Lodz, Poland, 94-060
Plock, Poland, 09-402
Poznan, Poland, 61-655
Radom, Poland, 26-610
Warszawa, Poland, 02-692
Warszawa, Poland, 04-730
Warszawa, Poland, 01-231
Wroclaw, Poland, 50-088
Romania
Bacau, Romania, 600114
Baia Mare, Romania, 430123
Bucharest, Romania, 011794
Bucharest, Romania, 10507
Bucharest, Romania, 020475
Bucuresti, Romania, 20475
Constanta, Romania, 900591
Galati, Romania, 800371
Oradea, Romania, 410169
Ploiesti, Romania, 100342
Ploiesti, Romania, 100097
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, 82108
Bratislava, Slovakia, 821 02
Dolny Kubin, Slovakia, 026 01
Komarno, Slovakia, 94501
Levice, Slovakia, 95401
Levice, Slovakia, 93405
Lucenec, Slovakia, 98401
Prievidza, Slovakia, 97101
Trencin, Slovakia, 911 01
South Africa
Cape Town, South Africa, 7505
Cape Town, South Africa, 7130
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, 112
Taipei, Taiwan, 106
Taipei, Taiwan, 111
Taipei, Taiwan, 114
Taoyuan County, Taiwan, 333
Thailand
Bangkok, Thailand, 10400
Bangkok, Thailand, 10330
Chiang Mai, Thailand, 50200
Ukraine
Kharkiv, Ukraine, 61022
Kiev, Ukraine, 1004
Kiev, Ukraine, 02175
Lviv, Ukraine, 79010
Mykolaiv, Ukraine, 54003
Poltava, Ukraine, 36024
Ternopil, Ukraine, 46002
Vinnitsa, Ukraine, 21010
Zaporizhzhya, Ukraine, 69035
Zaporizhzhya, Ukraine, 69001
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, L7 8XP
Liverpool, United Kingdom, L22 0LG
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

No publications provided

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: August 26, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on August 28, 2014