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

NCT01018173 | Completed Phase 3

• 2 other identifiers: NC251132009-014986-22
• Study Type: interventional
• Target: 2,118
• Locations: 24 countries
• Sites: 286

Brief 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. 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.

Conditions

Diabetes Mellitus Type 2

Outcome Measures

Primary Outcomes (1)

• Time to cardiovascular composite primary endpoints

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

Secondary Outcomes (4)

• Secondary cardiovascular composite endpoints

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

• Individual components of primary cardiovascular composite endpoints

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

• Total mortality

  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)

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

Study Arms (2)

placebo

PLACEBO COMPARATOR

Drug: placebo

taspoglutide

EXPERIMENTAL

Drug: taspoglutide

Interventions

placebo DRUG

sc weekly

placebo

taspoglutide DRUG

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

taspoglutide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (288)

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Phoenix, Arizona, 85050, United States

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Tucson, Arizona, 85741, United States

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Buena Park, California, 90620, United States

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Calabasas, California, 91302, United States

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Fresno, California, 93720, United States

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Santa Ana, California, 92705, United States

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Walnut Creek, California, 94598, United States

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Centennial, Colorado, 80112, United States

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Colorado Springs, Colorado, 80907, United States

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Trumbull, Connecticut, 06611, United States

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Washington D.C., District of Columbia, 20010, United States

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Clearwater, Florida, 33765, United States

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Delray Beach, Florida, 33446, United States

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Jacksonville, Florida, 32216, United States

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Miami, Florida, 33126, United States

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Ponte Verde, Florida, 32081, United States

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Bloomingdale, Illinois, 60108, United States

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Chicago, Illinois, 60607, United States

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Chicago, Illinois, 60610, United States

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Evansville, Indiana, 47714, United States

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Baltimore, Maryland, 21204, United States

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Oxon Hill, Maryland, 20745, United States

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Jackson, Mississippi, 39202, United States

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St Louis, Missouri, 63141, United States

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North Platte, Nebraska, 69101, United States

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Omaha, Nebraska, 68131, United States

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Las Vegas, Nevada, 89101, United States

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Las Vegas, Nevada, 89104, United States

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Nashua, New Hampshire, 3063, United States

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Toms River, New Jersey, 08753, United States

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Mineola, New York, 11501, United States

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New York, New York, 10032, United States

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Calabash, North Carolina, 28467, United States

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Cary, North Carolina, 27518, United States

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Chapel Hill, North Carolina, 27514, United States

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Charlotte, North Carolina, 28209, United States

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Durham, North Carolina, 27713, United States

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Mooresville, North Carolina, 28117, United States

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Raleigh, North Carolina, 27607, United States

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Bismarck, North Dakota, 58501, United States

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Bismarck, North Dakota, 58507, United States

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Cleveland, Ohio, 44122, United States

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Kettering, Ohio, 45429, United States

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Toledo, Ohio, 43623, United States

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Bend, Oregon, 97701, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 97229, United States

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Beaver, Pennsylvania, 15009, United States

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Levittown, Pennsylvania, 19056, United States

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Philadelphia, Pennsylvania, 19140, United States

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Pottstown, Pennsylvania, 19464, United States

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Greer, South Carolina, 29651, United States

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Hickory Grove, South Carolina, 28602, United States

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Bristol, Tennessee, 37620, United States

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Johnson City, Tennessee, 37604, United States

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Austin, Texas, 78705, United States

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Carrollton, Texas, 75010, United States

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Dallas, Texas, 75220, United States

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Dallas, Texas, 75230, United States

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Dallas, Texas, 75246, United States

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Fort Worth, Texas, 76109, United States

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Houston, Texas, 77070, United States

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Irving, Texas, 75039, United States

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North Richland Hills, Texas, 76180, United States

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Richardson, Texas, 75080, United States

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San Antonio, Texas, 78229-4801, United States

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San Antonio, Texas, 78229, United States

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Temple, Texas, 76508, United States

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Salt Lake City, Utah, 84107, United States

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Burke, Virginia, 22015, United States

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Hampton, Virginia, 23666, United States

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Manassas, Virginia, 20110, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23219, United States

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Winchester, Virginia, 22601, United States

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Tacoma, Washington, 98405, United States

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Freemantle, Queensland, 6959, Australia

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Herston, Queensland, 4029, Australia

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Elizabeth Vale, South Australia, 5112, Australia

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Melbourne, Victoria, 3004, Australia

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Fortaleza, Ceará, 60135-170, Brazil

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Fortaleza, Ceará, 60430-370, Brazil

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Campina Grande do Sul, Paraná, 83430-000, Brazil

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Rio de Janeiro, Rio de Janeiro, 20211340, Brazil

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Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

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São Paulo, São Paulo, 01244-030, Brazil

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São Paulo, São Paulo, 04020-050, Brazil

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São Paulo, São Paulo, 04022-001, Brazil

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São Paulo, São Paulo, 04266-010, Brazil

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São Paulo, São Paulo, 05437-010, Brazil

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Byala, 7100, Bulgaria

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Pleven, 5800, Bulgaria

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Plovdiv, 4002, Bulgaria

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Sofia, 1142, Bulgaria

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Sofia, 1233, Bulgaria

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Varna, 9000, Bulgaria

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Barrie, Ontario, L4M 7G1, Canada

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Toronto, Ontario, M4G 3E8, Canada

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Montreal, Quebec, H2W 1T8, Canada

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Sherbrooke, Quebec, J1G 5K2, Canada

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Havířov, 76301, Czechia

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Jindřichův Hradec, 377 38, Czechia

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Mariánské Lázně, 353 01, Czechia

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Olomouc, 779 00, Czechia

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Pardubice, 530 02, Czechia

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Prague, 180 00, Czechia

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Rakovník, 269 01, Czechia

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Ricany U Prahy, 250 01, Czechia

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Semily, 513 31, Czechia

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Trutnov, 541 01, Czechia

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Uherské Hradiště, 686 06, Czechia

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Ústí nad Labem, 400 11, Czechia

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Aalborg, 9000, Denmark

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Ballerup Municipality, 2750, Denmark

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Hvidovre, 2650, Denmark

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Vejle, 7100, Denmark

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Paide, 72714, Estonia

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Saku, 75501, Estonia

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Tallinn, 10128, Estonia

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Tallinn, 11911, Estonia

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Tallinn, 13415, Estonia

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Tallinn, 13419, Estonia

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Tartu, 50410, Estonia

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Tartu, 51010, Estonia

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Viljandimaa, 71024, Estonia

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Võru, 65608, Estonia

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Bad Lauterberg im Harz, 37431, Germany

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Bad Oeynhausen, 32545, Germany

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Bochum, 44789, Germany

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Dortmund, 44137, Germany

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Dresden, 01307, Germany

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Essen, 45359, Germany

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Hamburg, 22607, Germany

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Kleve, 47533, Germany

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Neuss, 41460, Germany

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Nuremberg, 90402, Germany

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Wuppertal, 42117, Germany

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Balatonfüred, 8230, Hungary

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Budapest, 1036, Hungary

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Budapest, 1095, Hungary

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Budapest, 1096, Hungary

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Debrecen, 4025, Hungary

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Gyula, 5700, Hungary

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Hódmezővásárhely, 6800, Hungary

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Komárom, 2921, Hungary

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Makó, 6900, Hungary

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Sopron, 9400, Hungary

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Szikszó, 3800, Hungary

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Úrhida, 8142, Hungary

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Veszprém, 8200, Hungary

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Ahmedabad, 382428, India

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Aurangabad, 431005, India

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Bangalore, 560003, India

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Bangalore, 560010, India

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Bangalore, 560052, India

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Bangalore, 560078, India

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Banglore, 560034, India

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Bhopal, 462003, India

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Chennai, 600006, India

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Chennai, 600013, India

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Chennai, 600086, India

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Hyderabad, 500 033, India

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Jaipur, 302001, India

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Kochi, 682026, India

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Kolkata, 700053, India

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Madurai, 625020, India

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Mangalore, 575001, India

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Mumbai, 400007, India

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Mumbai, 400012, India

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Nagpur, 440010, India

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Nagpur, 440012, India

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Pune, 411 001, India

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Pune, 411004, India

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Pune, 411011, India

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Jerusalem, 91200, Israel

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Alytus, 62381, Lithuania

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Kaunas, 49427, Lithuania

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Kaunas, 50009, Lithuania

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Kaunas, 51270, Lithuania

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Kaunas, LT-48426, Lithuania

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Klaipėda, 92304, Lithuania

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Panevezys, 35144, Lithuania

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Vilnius, 04318, Lithuania

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Vilnius, 08661, Lithuania

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George Town, 10450, Malaysia

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Johor Bahru, 80100, Malaysia

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Kelantan, 16150, Malaysia

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Aguascalientes, 20127, Mexico

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Chihuahua City, 31238, Mexico

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Cuernavaca, 62250, Mexico

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Culiacán, 80020, Mexico

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Durango, 34000, Mexico

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Juarez, Distrito Federal, 6600, Mexico

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Mexico City, 14000, Mexico

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México, 06100, Mexico

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Monterrey, 64460, Mexico

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Tampico, 89000, Mexico

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Gdansk, 80-858, Poland

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Gdynia, 81-384, Poland

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Kamieniec Ząbkowicki, 57-230, Poland

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Katowice, 40-748, Poland

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Kielce, 25-315, Poland

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Krakow, 31-261, Poland

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Krakow, 31-548, Poland

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Lodz, 94-060, Poland

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Poznan, 61-655, Poland

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Płock, 09-402, Poland

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Radom, 26-610, Poland

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Warsaw, 01-231, Poland

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Warsaw, 02-692, Poland

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Warsaw, 04-730, Poland

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Wroclaw, 50-088, Poland

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Bacau, 600114, Romania

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Baia Mare, 430123, Romania

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Bucharest, 011794, Romania

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Bucharest, 020475, Romania

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Bucharest, 10507, Romania

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Bucharest, 20475, Romania

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Constanța, 900591, Romania

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Galati, 800371, Romania

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Oradea, 410169, Romania

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Ploieşti, 100097, Romania

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Ploieşti, 100342, Romania

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Târgu Mureş, 540142, Romania

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Timișoara, 300456, Romania

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Barnaul, 656055, Russia

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Kemerovo, 650099, Russia

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Moscow, 125299, Russia

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Novosibirsk, 630090, Russia

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S. Petersburg, 194291, Russia

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Saint Petersburg, 193318, Russia

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Saint Petersburg, 197706, Russia

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Banská Bystrica, 975 17, Slovakia

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Bratislava, 813 69, Slovakia

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Bratislava, 821 02, Slovakia

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Bratislava, 82108, Slovakia

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Dolný Kubín, 026 01, Slovakia

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Komárno, 94501, Slovakia

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Levice, 93405, Slovakia

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Levice, 95401, Slovakia

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Lučenec, 98401, Slovakia

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Prievidza, 97101, Slovakia

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Trenčín, 911 01, Slovakia

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Cape Town, 7130, South Africa

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Cape Town, 7505, South Africa

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Durban, 4091, South Africa

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Johannesburg, 1619, South Africa

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Johannesburg, 2113, South Africa

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Observatory, Cape Town, 7925, South Africa

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Port Elizabeth, 6014, South Africa

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Pretoria, 0112, South Africa

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Pretoria, 0184, South Africa

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Richards Bay, 3900, South Africa

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Soweto, 1818, South Africa

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Soweto, 2013, South Africa

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Lugo, Lugo, 27004, Spain

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Madrid, Madrid, 28040, Spain

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Taichung, 404, Taiwan

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Taipei, 106, Taiwan

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Taipei, 111, Taiwan

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Taipei, 112, Taiwan

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Taipei, 114, Taiwan

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Taoyuan, 333, Taiwan

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Bangkok, 10330, Thailand

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Bangkok, 10400, Thailand

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Chiang Mai, 50200, Thailand

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Kharkiv, 61022, Ukraine

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Kiev, 02175, Ukraine

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Kiev, 1004, Ukraine

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Lviv, 79010, Ukraine

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Mykolaiv, 54003, Ukraine

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Poltava, 36024, Ukraine

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Ternopil, 46002, Ukraine

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Vinnitsa, 21010, Ukraine

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Zaporizhzhya, 69001, Ukraine

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Zaporizhzhya, 69035, Ukraine

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Bexhill-on-Sea, TN39 4SP, United Kingdom

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Birmingham, B15 2SQ, United Kingdom

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Cardiff, CF14 5GJ, United Kingdom

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Chorley, PR7 7NA, United Kingdom

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Dundee, DD1 9SY, United Kingdom

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Glasgow, G20 0SP, United Kingdom

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Liverpool, L22 0LG, United Kingdom

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Liverpool, L7 8XP, United Kingdom

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London, E1 2ES, United Kingdom

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Manchester, M15 6SX, United Kingdom

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Reading, RG2 7AG, United Kingdom

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Salford, M6 8HD, United Kingdom

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MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

taspoglutide

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2009
• First Posted: November 23, 2009
• Study Start: January 1, 2010
• Primary Completion: January 1, 2011
• Study Completion: January 1, 2011
• Last Updated: November 2, 2016

Record last verified: 2016-11

Locations

CA (4); TH (3); MY (3); RO (13); DE (11); ES (10); LI (9); CZ (12); ZA (12); IL (1); GB (12); HU (13); BR (10); AU (4); DK (4); ME (10); RU (7); UA (10); BU (6); TW (6); US (76); IN (24); SL (11); PL (15)