A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Plus Pioglitazone.
NCT ID: NCT00744367
Last Updated: 2016-08-05
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
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE3
326 participants
INTERVENTIONAL
2008-10-31
2010-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Study of Taspoglutide Versus Placebo for the Treatment of Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Diet and Exercise.
NCT00744926
A Study of Taspoglutide Versus Placebo for the Treatment of Obese Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Metformin Monotherapy
NCT00823992
A Study of Taspoglutide Versus Pioglitazone in Patients With Type 2 Diabetes
NCT00909597
A Study of Taspoglutide in Patients With Inadequately Controlled Diabetes Mellitus Type 2 and Cardiovascular Disease
NCT01018173
A Study of Taspoglutide in Type 2 Diabetic Patients
NCT00811460
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo in addition to continued stable metformin plus pioglitazone treatment. After the first 24 weeks patients on placebo will be switched to taspoglutide 10mg once weekly or taspoglutide 20mg once weekly (after 4 weeks of taspoglutide 10mg once weekly.
metformin
\>1500 mg/day or maximum tolerated dose (MTD)
pioglitazone
\>= 30 mg/day
placebo
sc once weekly
taspoglutide
10 mg sc once weekly;
taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Taspoglutide 10mg
Taspoglutide 10mg once weekly in addition to continued stable metformin plus pioglitazone treatment
metformin
\>1500 mg/day or maximum tolerated dose (MTD)
pioglitazone
\>= 30 mg/day
taspoglutide
10 mg sc once weekly;
Taspoglutide 10mg/20mg
Taspoglutide 20 mg once weekly (after 4 weeks of taspoglutide 10 mg once weekly) in addition to continued stable metformin plus pioglitazone treatment.
metformin
\>1500 mg/day or maximum tolerated dose (MTD)
pioglitazone
\>= 30 mg/day
taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
metformin
\>1500 mg/day or maximum tolerated dose (MTD)
pioglitazone
\>= 30 mg/day
placebo
sc once weekly
taspoglutide
10 mg sc once weekly;
taspoglutide
20 mg sc once weekly (after 4 weeks of taspoglutide 10 mg sc once weekly)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* type 2 diabetes receiving pioglitazone (\>= 30 mg/day) and metformin (\>= 1500 mg/day) for at least 12 weeks prior to screening;
* HbA1c \>=7.0% and \<=10.0% at screening;
* BMI \>= 25 (\>23 for Asians) and \<=45 kg/m2 at screening;
* stable weight +/-5% for at least 12 weeks prior to screening.
Exclusion Criteria
* evidence of clinically significant diabetic complications;
* clinically symptomatic gastrointestinal disease;
* myocardial infarction, coronary artery bypass surgery, post-transplantation cardiomyopathy or stroke within the previous 6 months;
* known hemoglobinopathy or chronic anemia.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Birmingham, Alabama, United States
Huntsville, Alabama, United States
Muscle Shoals, Alabama, United States
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Buena Park, California, United States
Lancaster, California, United States
Loma Linda, California, United States
Rancho Cucamonga, California, United States
Roseville, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Wheat Ridge, Colorado, United States
Hamden, Connecticut, United States
Washington D.C., District of Columbia, United States
Bradenton, Florida, United States
Chiefland, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Plantation, Florida, United States
Tampa, Florida, United States
Nampa, Idaho, United States
Aurora, Illinois, United States
Libertyville, Illinois, United States
Evansville, Indiana, United States
Des Moines, Iowa, United States
Topeka, Kansas, United States
Lexington, Kentucky, United States
Madisonville, Kentucky, United States
New Orleans, Louisiana, United States
Frederick, Maryland, United States
Oxon Hill, Maryland, United States
Detroit, Michigan, United States
Ferndale, Michigan, United States
Kalamazoo, Michigan, United States
Biloxi, Mississippi, United States
Olive Branch, Mississippi, United States
City of Saint Peters, Missouri, United States
Omaha, Nebraska, United States
Omaha, Nebraska, United States
Las Vegas, Nevada, United States
Albany, New York, United States
Brooklyn, New York, United States
Hudson, New York, United States
Lake Success, New York, United States
Staten Island, New York, United States
Charlotte, North Carolina, United States
Charlotte, North Carolina, United States
Mooresville, North Carolina, United States
Wilmington, North Carolina, United States
Bismarck, North Dakota, United States
Athens, Ohio, United States
Cincinnati, Ohio, United States
Kettering, Ohio, United States
Norman, Oklahoma, United States
Medford, Oregon, United States
Beaver, Pennsylvania, United States
Bensalem, Pennsylvania, United States
Carlisle, Pennsylvania, United States
Levittown, Pennsylvania, United States
Melrose Park, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Cranston, Rhode Island, United States
Greer, South Carolina, United States
Bellaire, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
Federal Way, Washington, United States
Brasília, , Brazil
Forlateza, , Brazil
Fortaleza, , Brazil
Fortaleza, , Brazil
Fortaleza, , Brazil
Mogi Das Cruzes - Sp, , Brazil
Passo Fundo, , Brazil
Porto Alegre, , Brazil
Recife, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
São Paulo, , Brazil
Mount Pearl, Newfoundland and Labrador, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Montreal, Quebec, Canada
Pointe-Claire, Quebec, Canada
San José, , Costa Rica
Bondy, , France
Dijon, , France
Nantes, , France
Narbonne, , France
Falkensee, , Germany
Karlsruhe, , Germany
Mainz, , Germany
Neuwied, , Germany
Potsdam, , Germany
Guatemala City, , Guatemala
Guatemala City, , Guatemala
Chihuahua City, , Mexico
Jalisco, , Mexico
Mexico City, , Mexico
Carolina, , Puerto Rico
Guyanabo, San Juan, , Puerto Rico
San Juan, , Puerto Rico
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2008-001744-39
Identifier Type: -
Identifier Source: secondary_id
BC20963
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.