A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
NCT ID: NCT00744926
Last Updated: 2016-07-28
Study Results
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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COMPLETED
PHASE3
373 participants
INTERVENTIONAL
2008-08-31
2010-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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placebo
placebo
sc, once weekly
taspoglutide 10mg sc
taspoglutide
10mg sc, once weekly
taspoglutide 10mg/20mg sc
taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
Interventions
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placebo
sc, once weekly
taspoglutide
10mg sc, once weekly
taspoglutide
20mg sc, once weekly (after 4 weeks of taspoglutide 10mg sc once weekly)
Eligibility Criteria
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Inclusion Criteria
* drug naive patients with type 2 diabetes uncontrolled with diet and exercise;
* tested negative for anti-glutamic acid decarboxylase (anti-GAD) antibodies;
* C-peptide (fasting) \>=1.0ng/mL
* HbA1c \>=6.5% and \<=10.0% at screening;
* BMI \>=25 (\>23 for Asians) and \<=45kg/m2 at screening;
* stable weight +/- 5% for at least 12 weeks prior to screening.
Exclusion Criteria
* evidence of clinically significant diabetic complications;
* symptomatic poorly controlled diabetes;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Phoenix, Arizona, United States
Los Angeles, California, United States
Santa Ana, California, United States
Avon, Indiana, United States
Pahrump, Nevada, United States
Charlotte, North Carolina, United States
Greer, South Carolina, United States
Mt. Pleasant, South Carolina, United States
San Antonio, Texas, United States
Richmond, Virginia, United States
Adelaide, , Australia
St Leonards, , Australia
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Jerusalem, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Tel Aviv, , Israel
Acapulco, , Mexico
Aguascalientes, , Mexico
Chihuahua City, , Mexico
Hermosillo, , Mexico
Mexico City, , Mexico
Morelia, , Mexico
Lima, , Peru
San Isidro, , Peru
Bucharest, , Romania
Buzău, , Romania
Cluj-Napoca, , Romania
Ploieşti, , Romania
Ploieşti, , Romania
Tg. Mures, , Romania
Chelyabinsk, , Russia
Jaloslave, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
Moscow, , Russia
S. Petersburg, , Russia
S.petersburg, , Russia
Saint Petersburg, , Russia
Yaroslavl, , Russia
Dolný Kubín, , Slovakia
Levice, , Slovakia
Prešov, , Slovakia
Trenčín, , Slovakia
Žilina, , Slovakia
Changhua, , Taiwan
Tainan City, , Taiwan
Taipei, , Taiwan
Tapei County, , Taiwan
Chernivtsi, , Ukraine
Kiev, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Countries
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Other Identifiers
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2008-001765-28
Identifier Type: -
Identifier Source: secondary_id
BC20750
Identifier Type: -
Identifier Source: org_study_id
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