CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 500 enrolled
Drug / intervention
Alogliptin and glyburide +2 moredrug
Likely dose
Alogliptin 12.5 mg or 25 mg orally once daily with glyburideAI-extracted
Key inclusion· 7
  • ✓Diagnosis of type 2 diabetes mellitus with inadequate glycemic control on sulfonylurea monotherapy
  • ✓On stable sulfonylurea dose ≥10 mg glyburide equivalent (or ≥5 mg if documented maximum tolerated dose) for ≥8 weeks
  • ✓No other antidiabetic agents within 3 months prior to screening (exception: <7 days use allowed)
  • ✓BMI ≥23 and ≤45 kg/m²
Key exclusion· 11
  • ✕Urine albumin-to-creatinine ratio >1000 μg/mg at screening
  • ✕History of cancer (except squamous/basal cell skin cancer) not in full remission ≥5 years
  • ✕Laser treatment for proliferative diabetic retinopathy within 6 months
  • ✕History of treated diabetic gastric paresis

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00286468
NCT00286468Phase 3Completed
CompareCT.gov

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Determine the Efficacy and Safety of SYR110322 (SYR-322) When Used in Combination With a Sulfonylurea in Subjects With Type 2 Diabetes

Takeda·interventional·Posted Feb 3, 2006·Updated Feb 3, 2012

In Brief

A Phase 3 clinical trial evaluating Alogliptin and glyburide and Glyburide for Diabetes Mellitus. Completed, enrolled 500 participants across 68 sites in 15 countries.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of alogliptin, once daily (QD), combined with a sulfonylurea in adults with type 2 diabetes mellitus.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesArgentina, Australia, Brazil, Chile, Dominican Republic, Guatemala, India, Mexico, Netherlands, New Zealand, Peru, Poland, South Africa, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedFeb 3, 2006
Enrollment StartApr 1, 2006
Primary CompletionJun 1, 2007
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 20.4 years ago

Interventions

Alogliptin and glyburidedrug

Alogliptin 12.5 mg, tablets, orally, once daily and glyburide for up to 26 weeks.

Alogliptin and glyburidedrug

Alogliptin 25 mg, tablets, orally, once daily and glyburide for up to 26 weeks.

Glyburidedrug

Alogliptin placebo-matching tablets, orally, once daily and glyburide for up to 26 weeks.