AzTrials
AzTrials

Diabetes Mellitus Type 2Phase 3NCT01018173

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

A Phase 3 study testing taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 288 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
taspoglutide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
2,118 participants
Where
288 sitesin 25 countries
Study dates
Jan 2010to Jan 2011
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

288 sites in 25 countries.

288 sites in 25 countries

United States76 sites

  • Study site

    Austin, Texas, 78705

  • Study site

    Baltimore, Maryland, 21204

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bend, Oregon, 97701

  • Study site

    Bismarck, North Dakota, 58501

  • Study site

    Bismarck, North Dakota, 58507

  • Study site

    Bloomingdale, Illinois, 60108

  • Study site

    Bristol, Tennessee, 37620

  • Study site

    Buena Park, California, 90620

  • Study site

    Burke, Virginia, 22015

  • Study site

    Calabasas, California, 91302

  • Study site

    Calabash, North Carolina, 28467

  • Study site

    Carrollton, Texas, 75010

  • Study site

    Cary, North Carolina, 27518

  • Study site

    Centennial, Colorado, 80112

  • Study site

    Chapel Hill, North Carolina, 27514

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Chicago, Illinois, 60610

  • Study site

    Clearwater, Florida, 33765

  • Study site

    Cleveland, Ohio, 44122

  • Study site

    Colorado Springs, Colorado, 80907

  • Study site

    Dallas, Texas, 75220

  • Study site

    Dallas, Texas, 75230

  • Study site

    Dallas, Texas, 75246

  • Study site

    Delray Beach, Florida, 33446

  • Study site

    Durham, North Carolina, 27713

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fort Worth, Texas, 76109

  • Study site

    Fresno, California, 93720

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hampton, Virginia, 23666

  • Study site

    Hickory Grove, South Carolina, 28602

  • Study site

    Houston, Texas, 77070

  • Study site

    Irving, Texas, 75039

  • Study site

    Jackson, Mississippi, 39202

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Johnson City, Tennessee, 37604

  • Study site

    Kettering, Ohio, 45429

  • Study site

    Las Vegas, Nevada, 89101

  • Study site

    Las Vegas, Nevada, 89104

  • Study site

    Levittown, Pennsylvania, 19056

  • Study site

    Manassas, Virginia, 20110

  • Study site

    Medford, Oregon, 97504

  • Study site

    Miami, Florida, 33126

  • Study site

    Mineola, New York, 11501

  • Study site

    Mooresville, North Carolina, 28117

  • Study site

    Nashua, New Hampshire, 3063

  • Study site

    New York, New York, 10032

  • Study site

    Norfolk, Virginia, 23502

  • Study site

    North Platte, Nebraska, 69101

  • Study site

    North Richland Hills, Texas, 76180

  • Study site

    Omaha, Nebraska, 68131

  • Study site

    Oxon Hill, Maryland, 20745

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Study site

    Phoenix, Arizona, 85050

  • Study site

    Ponte Verde, Florida, 32081

  • Study site

    Portland, Oregon, 97229

  • Study site

    Pottstown, Pennsylvania, 19464

  • Study site

    Raleigh, North Carolina, 27607

  • Study site

    Richardson, Texas, 75080

  • Study site

    Richmond, Virginia, 23219

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    San Antonio, Texas, 78229-4801

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Santa Ana, California, 92705

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Tacoma, Washington, 98405

  • Study site

    Temple, Texas, 76508

  • Study site

    Toledo, Ohio, 43623

  • Study site

    Toms River, New Jersey, 08753

  • Study site

    Trumbull, Connecticut, 06611

  • Study site

    Tucson, Arizona, 85741

  • Study site

    Walnut Creek, California, 94598

  • Study site

    Washington D.C., District of Columbia, 20010

  • Study site

    Winchester, Virginia, 22601

Other trials in United States

India24 sites

  • Study site

    Ahmedabad, 382428

  • Study site

    Bangalore, 560003

  • Study site

    Bangalore, 560010

  • Study site

    Bangalore, 560052

  • Study site

    Bangalore, 560078

  • Study site

    Banglore, 560034

  • Study site

    Bhopal, 462003

  • Study site

    Chennai, 600006

  • Study site

    Chennai, 600013

  • Study site

    Chennai, 600086

  • Study site

    Chhatrapati Sambhajinagar, 431005

  • Study site

    Hyderabad, 500 033

  • Study site

    Jaipur, 302001

  • Study site

    Kochi, 682026

  • Study site

    Kolkata, 700053

  • Study site

    Madurai, 625020

  • Study site

    Mangalore, 575001

  • Study site

    Mumbai, 400007

  • Study site

    Mumbai, 400012

  • Study site

    Nagpur, 440010

  • Study site

    Nagpur, 440012

  • Study site

    Pune, 411 001

  • Study site

    Pune, 411004

  • Study site

    Pune, 411011

Other trials in India

Poland15 sites

  • Study site

    Gdansk, 80-858

  • Study site

    Gdynia, 81-384

  • Study site

    Kamieniec Ząbkowicki, 57-230

  • Study site

    Katowice, 40-748

  • Study site

    Kielce, 25-315

  • Study site

    Krakow, 31-261

  • Study site

    Krakow, 31-548

  • Study site

    Lodz, 94-060

  • Study site

    Płock, 09-402

  • Study site

    Poznan, 61-655

  • Study site

    Radom, 26-610

  • Study site

    Warsaw, 01-231

  • Study site

    Warsaw, 02-692

  • Study site

    Warsaw, 04-730

  • Study site

    Wroclaw, 50-088

Other trials in Poland

Hungary13 sites

  • Study site

    Balatonfüred, 8230

  • Study site

    Budapest, 1036

  • Study site

    Budapest, 1095

  • Study site

    Budapest, 1096

  • Study site

    Debrecen, 4025

  • Study site

    Gyula, 5700

  • Study site

    Hódmezővásárhely, 6800

  • Study site

    Komárom, 2921

  • Study site

    Makó, 6900

  • Study site

    Sopron, 9400

  • Study site

    Szikszó, 3800

  • Study site

    Úrhida, 8142

  • Study site

    Veszprém, 8200

Other trials in Hungary

Romania13 sites

  • Study site

    Bacau, 600114

  • Study site

    Baia Mare, 430123

  • Study site

    Bucharest, 011794

  • Study site

    Bucharest, 020475

  • Study site

    Bucharest, 10507

  • Study site

    Bucharest, 20475

  • Study site

    Constanța, 900591

  • Study site

    Galati, 800371

  • Study site

    Oradea, 410169

  • Study site

    Ploieşti, 100097

  • Study site

    Ploieşti, 100342

  • Study site

    Târgu Mureş, 540142

  • Study site

    Timișoara, 300456

Other trials in Romania

Czechia12 sites

  • Study site

    Havířov, 76301

  • Study site

    Jindřichův Hradec, 377 38

  • Study site

    Mariánské Lázně, 353 01

  • Study site

    Olomouc, 779 00

  • Study site

    Pardubice, 530 02

  • Study site

    Prague, 180 00

  • Study site

    Rakovník, 269 01

  • Study site

    Ricany U Prahy, 250 01

  • Study site

    Semily, 513 31

  • Study site

    Trutnov, 541 01

  • Study site

    Uherské Hradiště, 686 06

  • Study site

    Ústí nad Labem, 400 11

Other trials in Czechia

South Africa12 sites

  • Study site

    Cape Town, 7130

  • Study site

    Cape Town, 7505

  • Study site

    Durban, 4091

  • Study site

    Johannesburg, 1619

  • Study site

    Johannesburg, 2113

  • Study site

    Observatory, Cape Town, 7925

  • Study site

    Port Elizabeth, 6014

  • Study site

    Pretoria, 0112

  • Study site

    Pretoria, 0184

  • Study site

    Richards Bay, 3900

  • Study site

    Soweto, 1818

  • Study site

    Soweto, 2013

Other trials in South Africa

United Kingdom12 sites

  • Study site

    Bexhill-on-Sea, TN39 4SP

  • Study site

    Birmingham, B15 2SQ

  • Study site

    Cardiff, CF14 5GJ

  • Study site

    Chorley, PR7 7NA

  • Study site

    Dundee, DD1 9SY

  • Study site

    Glasgow, G20 0SP

  • Study site

    Liverpool, L22 0LG

  • Study site

    Liverpool, L7 8XP

  • Study site

    London, E1 2ES

  • Study site

    Manchester, M15 6SX

  • Study site

    Reading, RG2 7AG

  • Study site

    Salford, M6 8HD

Other trials in United Kingdom

Germany11 sites

  • Study site

    Bad Lauterberg im Harz, 37431

  • Study site

    Bad Oeynhausen, 32545

  • Study site

    Bochum, 44789

  • Study site

    Dortmund, 44137

  • Study site

    Dresden, 01307

  • Study site

    Essen, 45359

  • Study site

    Hamburg, 22607

  • Study site

    Kleve, 47533

  • Study site

    Neuss, 41460

  • Study site

    Nuremberg, 90402

  • Study site

    Wuppertal, 42117

Other trials in Germany

Slovakia11 sites

  • Study site

    Banská Bystrica, 975 17

  • Study site

    Bratislava, 813 69

  • Study site

    Bratislava, 821 02

  • Study site

    Bratislava, 82108

  • Study site

    Dolný Kubín, 026 01

  • Study site

    Komárno, 94501

  • Study site

    Levice, 93405

  • Study site

    Levice, 95401

  • Study site

    Lučenec, 98401

  • Study site

    Prievidza, 97101

  • Study site

    Trenčín, 911 01

Other trials in Slovakia

Brazil10 sites

  • Study site

    Campina Grande do Sul, Paraná, 83430-000

  • Study site

    Fortaleza, Ceará, 60135-170

  • Study site

    Fortaleza, Ceará, 60430-370

  • Study site

    Rio de Janeiro, Rio de Janeiro, 20211340

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Study site

    São Paulo, São Paulo, 01244-030

  • Study site

    São Paulo, São Paulo, 04020-050

  • Study site

    São Paulo, São Paulo, 04022-001

  • Study site

    São Paulo, São Paulo, 04266-010

  • Study site

    São Paulo, São Paulo, 05437-010

Other trials in Brazil

Estonia10 sites

  • Study site

    Paide, 72714

  • Study site

    Saku, 75501

  • Study site

    Tallinn, 10128

  • Study site

    Tallinn, 11911

  • Study site

    Tallinn, 13415

  • Study site

    Tallinn, 13419

  • Study site

    Tartu, 50410

  • Study site

    Tartu, 51010

  • Study site

    Viljandimaa, 71024

  • Study site

    Võru, 65608

Other trials in Estonia

Mexico10 sites

  • Study site

    Aguascalientes, 20127

  • Study site

    Chihuahua City, 31238

  • Study site

    Cuernavaca, 62250

  • Study site

    Culiacán, 80020

  • Study site

    Durango, 34000

  • Study site

    Juarez, Distrito Federal, 6600

  • Study site

    México, 06100

  • Study site

    Mexico City, 14000

  • Study site

    Monterrey, 64460

  • Study site

    Tampico, 89000

Other trials in Mexico

Ukraine10 sites

  • Study site

    Kharkiv, 61022

  • Study site

    Kiev, 02175

  • Study site

    Kiev, 1004

  • Study site

    Lviv, 79010

  • Study site

    Mykolaiv, 54003

  • Study site

    Poltava, 36024

  • Study site

    Ternopil, 46002

  • Study site

    Vinnitsa, 21010

  • Study site

    Zaporizhzhya, 69001

  • Study site

    Zaporizhzhya, 69035

Other trials in Ukraine

Lithuania9 sites

  • Study site

    Alytus, 62381

  • Study site

    Kaunas, 49427

  • Study site

    Kaunas, 50009

  • Study site

    Kaunas, 51270

  • Study site

    Kaunas, LT-48426

  • Study site

    Klaipėda, 92304

  • Study site

    Panevezys, 35144

  • Study site

    Vilnius, 04318

  • Study site

    Vilnius, 08661

Other trials in Lithuania

Russia7 sites

  • Study site

    Barnaul, 656055

  • Study site

    Kemerovo, 650099

  • Study site

    Moscow, 125299

  • Study site

    Novosibirsk, 630090

  • Study site

    S. Petersburg, 194291

  • Study site

    Saint Petersburg, 193318

  • Study site

    Saint Petersburg, 197706

Other trials in Russia

Bulgaria6 sites

  • Study site

    Byala, 7100

  • Study site

    Pleven, 5800

  • Study site

    Plovdiv, 4002

  • Study site

    Sofia, 1142

  • Study site

    Sofia, 1233

  • Study site

    Varna, 9000

Other trials in Bulgaria

Taiwan6 sites

  • Study site

    Taichung, 404

  • Study site

    Taipei, 106

  • Study site

    Taipei, 111

  • Study site

    Taipei, 112

  • Study site

    Taipei, 114

  • Study site

    Taoyuan County, 333

Other trials in Taiwan

Australia4 sites

  • Study site

    Elizabeth Vale, South Australia, 5112

  • Study site

    Freemantle, Queensland, 6959

  • Study site

    Herston, Queensland, 4029

  • Study site

    Melbourne, Victoria, 3004

Other trials in Australia

Canada4 sites

  • Study site

    Barrie, Ontario, L4M 7G1

  • Study site

    Montreal, Quebec, H2W 1T8

  • Study site

    Sherbrooke, Quebec, J1G 5K2

  • Study site

    Toronto, Ontario, M4G 3E8

Other trials in Canada

Denmark4 sites

  • Study site

    Aalborg, 9000

  • Study site

    Ballerup Municipality, 2750

  • Study site

    Hvidovre, 2650

  • Study site

    Vejle, 7100

Other trials in Denmark

Malaysia3 sites

  • Study site

    George Town, 10450

  • Study site

    Johor Bahru, 80100

  • Study site

    Kelantan, 16150

Other trials in Malaysia

Thailand3 sites

  • Study site

    Bangkok, 10330

  • Study site

    Bangkok, 10400

  • Study site

    Chiang Mai, 50200

Other trials in Thailand

Spain2 sites

  • Study site

    Lugo, Lugo, 27004

  • Study site

    Madrid, Madrid, 28040

Other trials in Spain

Israel1 site

  • Study site

    Jerusalem, 91200

Other trials in Israel

About this study

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

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.

Being tested
placebo, taspoglutide
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • placeboDrug

    sc weekly

  • taspoglutideDrug

    10 mg sc weekly for 4 weeks, followed by 20 mg sc weekly

Study groups in NCT01018173
Study groupRoleWhat they receive
placeboPlacebo comparatorNot described
Receives: Drug: placebo
taspoglutideExperimentalNot described
Receives: Drug: taspoglutide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to cardiovascular composite primary endpoints

    Measured: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

Secondary outcomes (4)

  1. Secondary cardiovascular composite endpoints

    Measured: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

  2. Individual components of primary cardiovascular composite endpoints

    Measured: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter

  3. Total mortality

    Measured: 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)

    Measured: laboratory assessments weeks 4 and 12, and every 3 to 6 months thereafter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Nov 2009 (estimated)
  2. Study startJan 2010
  3. Primary completionJan 2011
  4. Study completionJan 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
2,118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01018173
Sponsor's protocol ID
NC25113
Other IDs
2009-014986-22, 2009
Status last verified
Nov 2016
First submitted
20 Nov 2009
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 288 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 288 sites in United States, India, Poland, Hungary, Romania and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to cardiovascular composite primary endpoints (time frame: event-driven, cardiovascular assessments weeks 1,4,12 and every 3 to 4 months thereafter). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01018173.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in