At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 803 enrolled
Drug / intervention
Alogliptin +3 moredrug
Likely dose
Metformin 1500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Randomized, Double-Blind Study to Determine the Efficacy and Safety of the Addition of SYR-322 25 mg Versus Dose Titration From 30 mg to 45 mg of Pioglitazone HCl (ACTOS®) in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Control on a Combination of Metformin and 30 mg of Pioglitazone HCl Therapy
In Brief
A Phase 3 clinical trial evaluating Alogliptin, Pioglitazone, and 2 other interventions for Diabetes Mellitus. Completed, enrolled 803 participants across 86 sites.
Detailed Summary
The purpose of the study is to compare the effect of adding alogliptin, once daily (QD), to the ongoing treatment regimen of pioglitazone HCl and metformin in patients with inadequate glycemic control.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2007
First PostedFeb 2007
Primary CompletionMay 2009
Study CompletionJun 2009
TodayJul 2026
First PostedFeb 7, 2007
Enrollment StartJan 1, 2007
Primary CompletionMay 1, 2009
Study CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 19.4 years ago
Interventions
Alogliptindrug
Alogliptin tablets.
Pioglitazonedrug
Pioglitazone tablets.
Metformindrug
Metformin HCl tablets (immediate-release, commercially available formulation) ≥1500 mg or maximum tolerated dose.
Placebodrug
Matching placebo tablets.