CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 312 enrolled
Drug / intervention
Alogliptin and glimepiride +2 moredrug
Likely dose
Alogliptin and glimepiride 12.5 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.

Search/NCT01318083
NCT01318083Phase 3Completed
CompareCT.gov

A Phase 2/3, Double-Blind, Randomized, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Efficacy and Safety of SYR-322 When Used in Combination With Sulfonylurea in Subjects With Type 2 Diabetes in Japan

Takeda·interventional·Posted Mar 18, 2011·Updated Feb 3, 2012

In Brief

A Phase 3 clinical trial evaluating Alogliptin and glimepiride and Glimepiride for Type 2 Diabetes Mellitus. Completed, enrolled 312 participants.

Detailed Summary

The purpose of this study was evaluate the efficacy and safety of alogliptin, once daily (QD) combined with an Sulfonylurea taken QD or twice daily (BID) in type 2 diabetic patients with uncontrolled blood glucose.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMar 18, 2011
Enrollment StartAug 1, 2008
Primary CompletionApr 1, 2009
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 15.3 years ago

Interventions

Alogliptin and glimepiridedrug

Alogliptin 12.5 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.

Alogliptin and glimepiridedrug

Alogliptin 25 mg, tablets, orally, once daily and glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily for up 12 weeks.

Glimepiridedrug

Glimepiride 1, 2, 3 or 4 mg, tablets, orally, once or twice daily and alogliptin placebo-matching tablets, orally, once daily for up 12 weeks.