AzTrials
AzTrials

Diabetes Mellitus Type 2Phase 3NCT00909597

A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes

A Phase 3 study testing pioglitazone and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 147 sites in 19 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 double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Diabetes Mellitus Type 2
What is being tested?
pioglitazone and taspoglutide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
756 participants
Where
147 sitesin 19 countries
Study dates
May 2009to Nov 2010
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 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • adult patients, 18-75 years of age;
  • type 2 diabetes mellitus;
  • treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for >=12 weeks prior to screening;
  • HbA1c >=7.0% and <=10% at screening;
  • stable weight +/-5% for >=12 weeks prior to screening.

Who cannot join

  • type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes;
  • clinically significant diabetic complications;
  • clinically symptomatic gastrointestinal disease;
  • >3 episodes of severe hypoglycemia within 6 months before screening.

Trial locations and contacts

147 sites in 19 countries.

147 sites in 19 countries

United States57 sites

  • Study site

    Atlanta, Georgia, 30338

  • Study site

    Ayer, Massachusetts, 01432

  • Study site

    Beaver, Pennsylvania, 15009

  • Study site

    Bend, Oregon, 97701

  • Study site

    Berlin, New Jersey, 08009

  • Study site

    Bethesda, Maryland, 20817

  • Study site

    Biloxi, Mississippi, 39531

  • Study site

    Brick, New Jersey, 08724

  • Study site

    Buena Park, California, 90620

  • Study site

    Chicago, Illinois, 60607

  • Study site

    Chicago, Illinois, 60610-4319

  • Study site

    Chiefland, Florida, 32626

  • Study site

    Chino, California, 91710

  • Study site

    Columbus, Georgia, 31904

  • Study site

    Conyers, Georgia, 30094

  • Study site

    Coral Gables, Florida, 33134

  • Study site

    Dallas, Texas, 75230

  • Study site

    Daytona Beach, Florida, 32117

  • Study site

    Durham, North Carolina, 27713

  • Study site

    Evansville, Indiana, 47714

  • Study site

    Fargo, North Dakota, 58103

  • Study site

    Ferndale, Michigan, 48220

  • Study site

    Grand Island, Nebraska, 68803

  • Study site

    Houston, Texas, 77074

  • Study site

    Jackson, Mississippi, 39216

  • Study site

    Kingsport, Tennessee, 37660

  • Study site

    Los Angeles, California, 90057

  • Study site

    Madisonville, Kentucky, 42431

  • Study site

    Medford, Oregon, 97504

  • Study site

    Metairie, Louisiana, 70006

  • Study site

    Minneapolis, Minnesota, 55416

  • Study site

    Mooresville, North Carolina, 28117

  • Study site

    New York, New York, 10021

  • Study site

    Olive Branch, Mississippi, 38654

  • Study site

    Panama City, Florida, 32401

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Port Charlotte, Florida, 33948

  • Study site

    Rancho Cucamonga, California, 91730

  • Study site

    Richmond, Virginia, 23226

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Roseville, California, 95661

  • Study site

    Roswell, Georgia, 30076

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    Santa Ana, California, 92701

  • Study site

    Scranton, Pennsylvania, 18510

  • Study site

    South Burlington, Vermont, 05403

  • Study site

    Spokane, Washington, 99202

  • Study site

    Springfield, Illinois, 62704-1433

  • Study site

    St. Petersburg, Florida, 33716

  • Study site

    Staten Island, New York, 10301

  • Study site

    Toms River, New Jersey, 08753

  • Study site

    Trenton, New Jersey, 08611

  • Study site

    Vancouver, Washington, 98664

  • Study site

    Waltham, Massachusetts, 02453

  • Study site

    Waukesha, Wisconsin, 53189

  • Study site

    Winston-Salem, North Carolina, 27103

  • Study site

    Winter Park, Florida, 32789

Other trials in United States

Russia14 sites

  • Study site

    Moscow, 117036

  • Study site

    Moscow, 121069

  • Study site

    Moscow, 127299

  • Study site

    Penza, 440026

  • Study site

    S.Petersburg, 194017

  • Study site

    Saint Petersburg, 193012

  • Study site

    Saint Petersburg, 194156

  • Study site

    Saint Petersburg, 194354

  • Study site

    Saint Petersburg, 195057

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saratov, 140018

  • Study site

    Voronezh, 394018

  • Study site

    Yaroslavl, 150023

  • Study site

    Yaroslavl, 150062

Other trials in Russia

Brazil9 sites

  • Study site

    Belo Horizonte, Minas Gerais, 30150-221

  • Study site

    Fortaleza, Ceará, 60430-370

  • Study site

    Lago Sul, Federal District, 71625009

  • Study site

    Marília, São Paulo, 17519030

  • Study site

    São Paulo, São Paulo, 01221-020

  • 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

    Sorocaba, São Paulo, 18047-360

Other trials in Brazil

Germany9 sites

  • Study site

    Berlin, 10115

  • Study site

    Essen, 45359

  • Study site

    Falkensee, 14612

  • Study site

    Mainz, 55116

  • Study site

    Münster, 48145

  • Study site

    Rodgau, 63110

  • Study site

    Siegen, 57074

  • Study site

    Sulzbach-Rosenberg, 92237

  • Study site

    Wangen, 88239

Other trials in Germany

France7 sites

  • Study site

    Besançon, 25030

  • Study site

    Corbeil-Essonnes, 91106

  • Study site

    Dommartin-lès-Toul, 54200

  • Study site

    La Rochelle, 17019

  • Study site

    Lille, 59037

  • Study site

    Poitiers, 86021

  • Study site

    Vénissieux, 69200

Other trials in France

Mexico7 sites

  • Study site

    Aguascaliente, 20230

  • Study site

    Celaya, 38000

  • Study site

    Cuernavaca, 62250

  • Study site

    Guadalajara, 44100

  • Study site

    Guadalajara, 44650

  • Study site

    Mexico City, 06700

  • Study site

    Monterrey, 64460

Other trials in Mexico

United Kingdom7 sites

  • Study site

    Atherstone, CV9 1EU

  • Study site

    Birmingham, B9 5SS

  • Study site

    Chesterfield, S40 4TF

  • Study site

    Dumfries, DG1 4AP

  • Study site

    Glasgow, G45 9AW

  • Study site

    Hinckley, LE10 2SE

  • Study site

    Reading, RG7 3SQ

Other trials in United Kingdom

Canada6 sites

  • Study site

    Etobicoke, Ontario, M9R 4E1

  • Study site

    London, Ontario, N6A 5R8

  • Study site

    Thornhill, Ontario, L4J 8L7

  • Study site

    Toronto, Ontario, M4G 3E8

  • Study site

    Toronto, Ontario, M9W 4L6

  • Study site

    Vancouver, British Columbia, V6H 3X8

Other trials in Canada

Poland6 sites

  • Study site

    Gdansk, 80-858

  • Study site

    Krakow, 30-015

  • Study site

    Krakow, 31-455

  • Study site

    Lublin, 20-044

  • Study site

    Lublin, 20-538

  • Study site

    Wroclaw, 50-044

Other trials in Poland

Spain5 sites

  • Study site

    Almería, Almeria, 04001

  • Study site

    Barakaldo, Vizcaya, 48903

  • Study site

    Barcelona, Barcelona, 08907

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Pamplona, Navarre, 31008

Other trials in Spain

Slovakia4 sites

  • Study site

    Bratislava, 851 01

  • Study site

    Dolný Kubín, 026 01

  • Study site

    Levice, 034 01

  • Study site

    Levice, 93405

Other trials in Slovakia

Ukraine4 sites

  • Study site

    Kiev, 04050

  • Study site

    Odesa, 65009

  • Study site

    Odesa, 65117

  • Study site

    Vinnitsa, 21010

Other trials in Ukraine

Thailand3 sites

  • Study site

    Chiang Mai, 50200

  • Study site

    Pathum Thani, 12120

  • Study site

    Songkhla, 90112

Other trials in Thailand

Australia2 sites

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Wollongong, New South Wales, 2500

Other trials in Australia

Costa Rica2 sites

  • Study site

    San José, 4395-1000

  • Study site

    San José, 755-1000

Other trials in Costa Rica

New Zealand2 sites

  • Study site

    Auckland, 1640

  • Study site

    Auckland

Other trials in New Zealand

Peru1 site

  • Study site

    San Isidro, 27

Other trials in Peru

Puerto Rico1 site

  • Study site

    Rio Piedras, 00926

Other trials in Puerto Rico

South Africa1 site

  • Study site

    Cape Town, 7130

Other trials in South Africa

About this study

Official title: A Multicenter, Randomized, Double Blind (Double Dummy), Active Controlled Study to Compare the Safety, Tolerability and Effect on Glycemic Control of Taspoglutide Versus Pioglitazone in Type 2 Diabetes Patients Inadequately Controlled on Therapy With Sulfonylurea or Metformin Plus Sulfonylurea

This double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. After an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.The anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.

Being tested
pioglitazone, 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.

  • pioglitazoneDrug

    30mg po once daily for 4 weeks, followed by 45mg once daily

  • taspoglutideDrug

    10mg sc once weekly

  • taspoglutideDrug

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

Study groups in NCT00909597
Study groupRoleWhat they receive
pioglitazoneActive comparatorNot described
Receives: Drug: pioglitazone
taspoglutide 10mgExperimentaltaspoglutide 10mg sc weekly
Receives: Drug: taspoglutide
taspoglutide 10mg/20mgExperimentaltaspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly
Receives: Drug: taspoglutide

What is being measured

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

  1. Absolute change from baseline in HbA1c

    Measured: 24 weeks

Secondary outcomes (3)

  1. Proportion of patients achieving target HbA1c <=6.5%, <=7%

    Measured: weeks 24, 52 and 104

  2. Absolute/percentage change from baseline in body weight; responder rate for body weight; absolute/percentage change from baseline in waist and hip circumference;absolute/percentage change from baseline in fasting plasma glucose

    Measured: weeks 24, 52 and 104

  3. Adverse events; laboratory parameters; cardiovascular events

    Measured: At each clinic visit up to 106 weeks

Timeline

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

  1. First posted28 May 2009 (estimated)
  2. Study startMay 2009
  3. Primary completionNov 2010
  4. Study completionNov 2010

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
756 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00909597
Sponsor's protocol ID
BC21893
Other IDs
2009-009157-24, 2009
Status last verified
Nov 2016
First submitted
27 May 2009
Last updated
2 Nov 2016
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pioglitazone and taspoglutide in people with Diabetes Mellitus Type 2, run by Hoffmann-La Roche at 147 sites in 19 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 4 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 147 sites in United States, Russia, Brazil, Germany, France and 14 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. 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?

Absolute change from baseline in HbA1c (time frame: 24 weeks). 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 NCT00909597.

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