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

November 1, 2016 updated by: Hoffmann-La Roche

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2118

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Freemantle, Queensland, Australia, 6959
      • Herston, Queensland, Australia, 4029
    • South Australia
      • Elizabeth Vale, South Australia, Australia, 5112
    • Victoria
      • Melbourne, Victoria, Australia, 3004
  • Brazil
    • CE
      • Fortaleza, CE, Brazil, 60430-370
      • Fortaleza, CE, Brazil, 60135-170
    • PR
      • Campina Grande do Sul, PR, Brazil, 83430-000
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22271-100
      • Rio de Janeiro, RJ, Brazil, 20211340
    • SP
      • Sao Paulo, SP, Brazil, 04266-010
      • Sao Paulo, SP, Brazil, 01244-030
      • Sao Paulo, SP, Brazil, 04022-001
      • Sao Paulo, SP, Brazil, 05437-010
      • Sao Paulo, SP, Brazil, 04020-050
  • 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
    • 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, 13419
      • Tallinn, Estonia, 13415
      • Tallinn, Estonia, 11911
      • 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, 1096
      • 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, 560010
      • Bangalore, India, 560003
      • 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, 400012
      • Mumbai, India, 400007
      • Nagpur, India, 440012
      • Nagpur, India, 440010
      • Pune, India, 411004
      • Pune, India, 411 001
      • Pune, India, 411011
  • Israel
      • Jerusalem, Israel, 91200
  • Lithuania
      • Alytus, Lithuania, 62381
      • Kaunas, Lithuania, 50009
      • Kaunas, Lithuania, 49427
      • Kaunas, Lithuania, 51270
      • Kaunas, Lithuania, LT-48426
      • 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, 31-261
      • Krakow, Poland, 31-548
      • Lodz, Poland, 94-060
      • Plock, Poland, 09-402
      • Poznan, Poland, 61-655
      • Radom, Poland, 26-610
      • Warszawa, Poland, 04-730
      • Warszawa, Poland, 01-231
      • Warszawa, Poland, 02-692
      • Wroclaw, Poland, 50-088
  • Romania
      • Bacau, Romania, 600114
      • Baia Mare, Romania, 430123
      • Bucharest, Romania, 020475
      • Bucharest, Romania, 011794
      • Bucharest, Romania, 10507
      • 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, 197706
      • St. Petersburg, Russian Federation, 193318
  • 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, 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, 0184
      • Pretoria, South Africa, 0112
      • 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, 114
      • Taipei, Taiwan, 112
      • Taipei, Taiwan, 106
      • Taipei, Taiwan, 111
      • Taoyuan County, Taiwan, 333
  • Thailand
      • Bangkok, Thailand, 10400
      • Bangkok, Thailand, 10330
      • 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, 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
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85050
      • Tucson, Arizona, United States, 85741
    • 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
    • Colorado
      • Centennial, Colorado, United States, 80112
      • Colorado Springs, Colorado, United States, 80907
    • Connecticut
      • Trumbull, Connecticut, United States, 06611
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
    • 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
    • Illinois
      • Bloomingdale, Illinois, United States, 60108
      • Chicago, Illinois, United States, 60610
      • Chicago, Illinois, United States, 60607
    • Indiana
      • Evansville, Indiana, United States, 47714
    • Maryland
      • Baltimore, Maryland, United States, 21204
      • Oxon Hill, Maryland, United States, 20745
    • Mississippi
      • Jackson, Mississippi, United States, 39202
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • Nebraska
      • North Platte, Nebraska, United States, 69101
      • Omaha, Nebraska, United States, 68131
    • Nevada
      • Las Vegas, Nevada, United States, 89104
      • Las Vegas, Nevada, United States, 89101
    • New Hampshire
      • Nashua, New Hampshire, United States, 3063
    • New Jersey
      • Toms River, New Jersey, United States, 08753
    • New York
      • Mineola, New York, United States, 11501
      • New York, New York, United States, 10032
    • 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
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
      • Bismark, North Dakota, United States, 58507
    • Ohio
      • Cleveland, Ohio, United States, 44122
      • Kettering, Ohio, United States, 45429
      • Toledo, Ohio, United States, 43623
    • Oregon
      • Bend, Oregon, United States, 97701
      • Medford, Oregon, United States, 97504
      • Portland, Oregon, United States, 97229
    • Pennsylvania
      • Beaver, Pennsylvania, United States, 15009
      • Levittown, Pennsylvania, United States, 19056
      • Philadelphia, Pennsylvania, United States, 19140
      • Pottstown, Pennsylvania, United States, 19464
    • South Carolina
      • Greer, South Carolina, United States, 29651
      • Hickory, South Carolina, United States, 28602
    • Tennessee
      • Bristol, Tennessee, United States, 37620
      • Johnson City, Tennessee, United States, 37604
    • Texas
      • Austin, Texas, United States, 78705
      • Carrollton, Texas, United States, 75010
      • Dallas, Texas, United States, 75246
      • Dallas, Texas, United States, 75230
      • Dallas, Texas, United States, 75220
      • 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
    • Utah
      • Salt Lake City, Utah, United States, 84107
    • 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
    • Washington
      • Tacoma, Washington, United States, 98405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to cardiovascular composite primary endpoints
Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

Secondary Outcome Measures

Outcome Measure
Time Frame
Secondary cardiovascular composite endpoints
Time Frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter
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
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
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
laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

November 20, 2009

First Submitted That Met QC Criteria

November 20, 2009

First Posted (Estimate)

November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NC25113
  • 2009-014986-22

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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