Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes in Japan
NCT ID: NCT01263470
Last Updated: 2012-02-03
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2
480 participants
INTERVENTIONAL
2007-01-31
2007-12-31
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.
Efficacy and Safety of Alogliptin Used in Combination With α-glucosidase Inhibitor in Participants With Type 2 Diabetes in Japan
NCT01263483
Efficacy and Safety of Alogliptin Used Combination With Thiazolidine in Participants With Type 2 Diabetes in Japan
NCT01318070
Efficacy and Safety of Alogliptin Used Combination With Metformin in Participants With Type 2 Diabetes in Japan
NCT01318109
Long-term Safety Study of Alogliptin in Participants With Type 2 Diabetes in Japan
NCT01263496
Efficacy and Safety of Alogliptin in Participants With Type 2 Diabetes
NCT01289119
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Takeda is developing SYR-322 (alogliptin) for the improvement of glycemic control in patients with type 2 diabetes mellitus. Alogliptin is an inhibitor of the dipeptidyl peptidase IV (DPP-IV) enzyme. DPP-IV is thought to be primarily responsible for the degradation of 2 peptide hormones released in response to nutrient ingestion. It is expected that inhibition of DPP-IV will improve glycemic control in patients with type 2 diabetes.
To evaluate the long-term safety and efficacy of alogliptin, participants in the present study could enter a long-term extension study SYR-322/OCT-001 (NCT01263496) that was planned separately.
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
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Alogliptin 6.25 mg QD
Alogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin 12.5 mg QD
Alogliptin
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 25 mg QD
Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin 50 mg QD
Alogliptin
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Voglibose 0.2 mg TID
Voglibose
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Alogliptin
Alogliptin 6.25 mg, tablets, orally, once daily for up to 12 weeks
Alogliptin
Alogliptin 12.5 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin
Alogliptin 25 mg, tablets, orally, once daily for up to 12 weeks.
Alogliptin
Alogliptin 50 mg, tablets, orally, once daily for up to 12 weeks
Voglibose
Voglibose 0.2 mg, tablets, orally, three times daily for up to 12 weeks.
Placebo
Placebo-matching tablets, orally, once or three times daily for up to 12 weeks.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* A HbA1c differences within 10.0%\* (\*rounded off to the first decimal point) at the start of screening (Week -8) and 4 weeks after the start of screening (Week -4) from the HbA1c value at the start of screening.
* Was receiving a specific diet therapy and an exercise therapy (if any) for the last 4 weeks or longer before the start of screening (Week -8).
Exclusion Criteria
20 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Takeda
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.
Professor, Department of Medicine
Role: STUDY_DIRECTOR
Kawasaki Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Okayama, , Japan
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.
U1111-1118-3752
Identifier Type: REGISTRY
Identifier Source: secondary_id
SYR-322/CCT-001
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.