CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 576 enrolled
Drug / intervention
Alogliptin and glimepiride +3 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/NCT01318135
NCT01318135Phase 3Completed
CompareCT.gov

A Long-term, Open-label Extension Study to Investigate the Long-term Safety of Alogliptin When Used in Combination With Sulfonylurea or Metformin in Subjects With Type 2 Diabetes in Japan

Takeda·interventional·Posted Mar 18, 2011·Updated Aug 16, 2012

In Brief

A Phase 3 clinical trial evaluating Alogliptin and glimepiride and Alogliptin and metformin for Type 2 Diabetes Mellitus. Completed, enrolled 576 participants.

Detailed Summary

To evaluate the efficacy and safety of alogliptin administered as an add-on to sulfonylurea (glimepiride) or metformin, once daily (QD), twice daily (BID) or three times daily (TID).

Study Details

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

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 18, 2011
Enrollment StartJan 1, 2009
Primary CompletionJan 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.3 years ago

Interventions

Alogliptin and glimepiridedrug

Alogliptin 12.5 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.

Alogliptin and glimepiridedrug

Alogliptin 25 mg, tablets, orally, once daily and sulfonylurea 1, 2, 3, 4, 5 or 6 mg, tablets, orally, once or twice daily for up to 52 weeks.

Alogliptin and metformindrug

Alogliptin 12.5 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.

Alogliptin and metformindrug

Alogliptin 25 mg, tablets, orally, once daily and metformin 500 mg, tablets, orally, twice daily or metformin 750 mg, tablets, orally, three times daily for up to 52 weeks.