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

NCT ID: NCT00909597

Last Updated: 2016-11-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

756 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Diabetes Mellitus Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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pioglitazone

Group Type ACTIVE_COMPARATOR

pioglitazone

Intervention Type DRUG

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

taspoglutide 10mg

taspoglutide 10mg sc weekly

Group Type EXPERIMENTAL

taspoglutide

Intervention Type DRUG

10mg sc once weekly

taspoglutide 10mg/20mg

taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly

Group Type EXPERIMENTAL

taspoglutide

Intervention Type DRUG

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

Interventions

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pioglitazone

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

Intervention Type DRUG

taspoglutide

10mg sc once weekly

Intervention Type DRUG

taspoglutide

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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Buena Park, California, United States

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Chino, California, United States

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Los Angeles, California, United States

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Rancho Cucamonga, California, United States

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Roseville, California, United States

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Santa Ana, California, United States

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Chiefland, Florida, United States

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Coral Gables, Florida, United States

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Daytona Beach, Florida, United States

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Panama City, Florida, United States

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Port Charlotte, Florida, United States

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St. Petersburg, Florida, United States

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Winter Park, Florida, United States

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Atlanta, Georgia, United States

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Columbus, Georgia, United States

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Conyers, Georgia, United States

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Roswell, Georgia, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Springfield, Illinois, United States

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Evansville, Indiana, United States

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Madisonville, Kentucky, United States

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Metairie, Louisiana, United States

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Bethesda, Maryland, United States

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Ayer, Massachusetts, United States

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Waltham, Massachusetts, United States

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Ferndale, Michigan, United States

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Minneapolis, Minnesota, United States

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Biloxi, Mississippi, United States

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Jackson, Mississippi, United States

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Olive Branch, Mississippi, United States

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Grand Island, Nebraska, United States

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Berlin, New Jersey, United States

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Brick, New Jersey, United States

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Toms River, New Jersey, United States

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Trenton, New Jersey, United States

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New York, New York, United States

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Staten Island, New York, United States

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Durham, North Carolina, United States

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Mooresville, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Bend, Oregon, United States

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Medford, Oregon, United States

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Beaver, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Scranton, Pennsylvania, United States

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Kingsport, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Salt Lake City, Utah, United States

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South Burlington, Vermont, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Spokane, Washington, United States

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Vancouver, Washington, United States

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Waukesha, Wisconsin, United States

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Camperdown, New South Wales, Australia

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Wollongong, New South Wales, Australia

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Fortaleza, Ceará, Brazil

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Lago Sul, Federal District, Brazil

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Belo Horizonte, Minas Gerais, Brazil

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Marília, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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São Paulo, São Paulo, Brazil

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Sorocaba, São Paulo, Brazil

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Vancouver, British Columbia, Canada

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Etobicoke, Ontario, Canada

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London, Ontario, Canada

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Thornhill, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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San José, , Costa Rica

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San José, , Costa Rica

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Besançon, , France

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Corbeil-Essonnes, , France

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Dommartin-lès-Toul, , France

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La Rochelle, , France

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Lille, , France

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Poitiers, , France

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Vénissieux, , France

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Berlin, , Germany

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Essen, , Germany

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Falkensee, , Germany

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Mainz, , Germany

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Münster, , Germany

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Rodgau, , Germany

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Siegen, , Germany

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Sulzbach-Rosenberg, , Germany

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Wangen, , Germany

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Aguascaliente, , Mexico

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Celaya, , Mexico

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Cuernavaca, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Mexico City, , Mexico

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Monterrey, , Mexico

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Auckland, , New Zealand

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Auckland, , New Zealand

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San Isidro, , Peru

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Gdansk, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Lublin, , Poland

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Wroclaw, , Poland

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Rio Piedras, , Puerto Rico

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Moscow, , Russia

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Moscow, , Russia

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Moscow, , Russia

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Penza, , Russia

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S.Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saint Petersburg, , Russia

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Saratov, , Russia

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Voronezh, , Russia

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Yaroslavl, , Russia

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Yaroslavl, , Russia

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Bratislava, , Slovakia

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Dolný Kubín, , Slovakia

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Levice, , Slovakia

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Levice, , Slovakia

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Cape Town, , South Africa

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Almería, Almeria, Spain

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Barcelona, Barcelona, Spain

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Pamplona, Navarre, Spain

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Oviedo, Principality of Asturias, Spain

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Barakaldo, Vizcaya, Spain

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Chiang Mai, , Thailand

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Pathum Thani, , Thailand

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Songkhla, , Thailand

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Kiev, , Ukraine

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Odesa, , Ukraine

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Odesa, , Ukraine

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Vinnitsa, , Ukraine

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Atherstone, , United Kingdom

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Birmingham, , United Kingdom

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Chesterfield, , United Kingdom

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Dumfries, , United Kingdom

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Glasgow, , United Kingdom

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Hinckley, , United Kingdom

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Reading, , United Kingdom

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Countries

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Italy United States Australia Brazil Canada Costa Rica France Germany Mexico New Zealand Peru Poland Puerto Rico Russia Slovakia South Africa Spain Thailand Ukraine United Kingdom

Other Identifiers

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2009-009157-24

Identifier Type: -

Identifier Source: secondary_id

BC21893

Identifier Type: -

Identifier Source: org_study_id