Long-term Safety of Alogliptin in Patients With Type 2 Diabetes Mellitus
NCT ID: NCT00306384
Last Updated: 2013-03-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3323 participants
INTERVENTIONAL
2006-03-31
2011-11-30
Brief Summary
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Detailed Description
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The rising incidence of type 2 diabetes mellitus and the limitations of the currently available treatments suggest the need for new therapies for glycemic control. Studies have been undertaken in humans that evaluated the effects of directly augmenting glucagon-like peptide-1 and glucose-dependent insulinotropic peptide levels and of inhibiting the activity of dipeptidyl peptidase IV.
This study is an extension of 7 controlled phase 3 studies of alogliptin. These phase 3 studies included 1 monotherapy study of alogliptin (SYR-322-PLC-010; NCT00286455); 4 placebo-controlled add-on studies of alogliptin, namely in combination with a sulfonylurea (SYR-322-SULF-007; NCT00286468), metformin (SYR-322-MET-008; NCT00286442), a thiazolidinedione (pioglitazone; SYR-322-TZD-009; NCT00286494), and insulin (SYR-322-INS-011; NCT00286429); 1 coadministration study with pioglitazone in combination with metformin (01-05-TL-322OPI-001; NCT00328627), and 1 coadministration study with pioglitazone (01-06-TL-322OPI-002; NCT00395512).
The end of treatment or early withdrawal visit from the preceding study will be the screening visit for this study, after which enrolled patients will be required to commit to approximately 22 additional visits at the study center.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Alogliptin 12.5 mg
Alogliptin 12.5 tablet, orally, once daily for up to 4 years.
Alogliptin
Alogliptin tablets.
Alogliptin 25 mg
Alogliptin 25 mg tablet, orally, once daily for up to 4 years.
Alogliptin
Alogliptin tablets.
Interventions
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Alogliptin
Alogliptin tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetes mellitus and was enrolled in one of the following 7 controlled Phase III studies. The study will be open to all patients who completed one of these studies through the end-of-treatment visit:
* SYR-322-PLC-010 - NCT00286455
* SYR-322-SULF-007 - NCT00286468
* SYR-322-MET-008 - NCT00286442
* SYR-322-TZD-009 - NCT00286494
* SYR-322-INS-011 - NCT00286429
* 01-05-TL-322OPI-001 - NCT00328627
* 01-06-TL-322OPI-002 - NCT00395512
* Alanine aminotransferase less than or equal to 3 times the upper limit of normal and serum creatinine less than or equal to 2.0 mg per dL.
* Able and willing to monitor own blood glucose concentrations with a home glucose monitor.
* No major illness or debility that in the investigator's opinion prohibits the patient from completing the study.
Exclusion Criteria
* Is required to take or intends to continue taking any disallowed medication, any prescription medication, herbal treatment or over-the counter medication that may interfere with evaluation of the study medication, including:
* Weight-loss drugs
* Investigational antidiabetics, additional dipeptidyl peptidase-4 (DPP-4) and glucagon-like peptide-1 (GLP 1) inhibitors
* Incretin Mimetics,
* Oral or systemically injected glucocorticoids.
18 Years
80 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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VP Biological Sciences
Role: STUDY_DIRECTOR
Takeda
Locations
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Birmingham, Alabama, United States
Peoria, Arizona, United States
Phoenix, Arizona, United States
Anaheim, California, United States
Artesia, California, United States
Fresno, California, United States
Los Angeles, California, United States
Mission Viejo, California, United States
Northridge, California, United States
Orange, California, United States
San Diego, California, United States
Tustin, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Denver, Colorado, United States
Norwalk, Connecticut, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Hollywood, Florida, United States
Kissimmee, Florida, United States
Longwood, Florida, United States
New Port Richie, Florida, United States
Ocala, Florida, United States
Ocoee, Florida, United States
Saint Cloud, Florida, United States
Lawrenceville, Georgia, United States
Honolulu, Hawaii, United States
Idaho Falls, Idaho, United States
Chicago, Illinois, United States
Avon, Indiana, United States
Elkhart, Indiana, United States
Evansville, Indiana, United States
Lafayette, Indiana, United States
Erlanger, Kentucky, United States
Baltimore, Maryland, United States
Sudbury, Massachusetts, United States
Chesterfield, Missouri, United States
St Louis, Missouri, United States
Omaha, Nebraska, United States
Berlin, New Jersey, United States
Burlington, North Carolina, United States
Charlotte, North Carolina, United States
Morehead City, North Carolina, United States
Pinehurst, North Carolina, United States
Winston-Salem, North Carolina, United States
Cincinnatti, Ohio, United States
Dayton, Ohio, United States
Tulsa, Oklahoma, United States
Medford, Oregon, United States
Lansdale, Pennsylvania, United States
West Grove, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Simpsonville, South Carolina, United States
Bristol, Tennessee, United States
Cookeville, Tennessee, United States
Milan, Tennessee, United States
Dallas, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Texarkana, Texas, United States
Burlington, Vermont, United States
Buenos Aires, La Plata, Argentina
Buenos Aires, Moron, Argentina
Rosario, Sante Fe, Argentina
Buenos Aires, , Argentina
Ciudadd Autonoma de Buenos Aires, , Argentina
Córdoba, , Argentina
Mar del Plata, , Argentina
Fortaleza, Ceará, Brazil
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Mogi das Cruzes, São Paulo, Brazil
Santos, São Paulo, Brazil
São Paulo, , Brazil
Santiago, , Chile
Ostrava, , Czechia
Prague, , Czechia
Sternberk, , Czechia
Zlín, , Czechia
Santo Domingo Oeste, , Dominican Republic
Aschaffenburg, , Germany
Berlin, , Germany
Frankfurt, , Germany
Hamburg, , Germany
Hanover, , Germany
Munich, , Germany
Nuremberg, , Germany
Schwerin, , Germany
Wiesbaden, , Germany
Witten, , Germany
Guatemala City, , Guatemala
Almere Stad, , Netherlands
De Bilt, , Netherlands
Geleen, , Netherlands
Oud-Beijerland, , Netherlands
Rotterdam, , Netherlands
Zwijndrecht, , Netherlands
Bellavista, Lima region, Peru
San Isidro, Lima region, Peru
Ica, , Peru
Lima, , Peru
Bytom, , Poland
Kamieniec Ząbkowicki, , Poland
Krakow, , Poland
Lodz, , Poland
Radom, , Poland
Łęczyca, , Poland
Pretoria, Gauteng, South Africa
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Durban, , South Africa
Johannesburg, , South Africa
Parow, , South Africa
Countries
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Other Identifiers
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2005-004672-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1113-8455
Identifier Type: REGISTRY
Identifier Source: secondary_id
SYR-322-OLE-012
Identifier Type: -
Identifier Source: org_study_id
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