CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 3,317 enrolled
Drug / intervention
Alogliptindrug
Likely dose
Not stated in 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/NCT01945216
NCT01945216N/ACompleted

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

Takeda·observational·Posted Sep 18, 2013·Updated Nov 19, 2019

In Brief

An observational study evaluating Alogliptin for Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution. Completed, enrolled 3,317 participants across 1 site.

Detailed Summary

The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesJapan
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedSep 18, 2013
Enrollment StartJul 8, 2010
Primary CompletionOct 31, 2015
TodayJul 2, 2026
Enrollment to primary: 5.3 yearsPosted 12.8 years ago

Interventions

Alogliptindrug

Alogliptin tablets