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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2118

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 20, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 20, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 2, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 1, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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