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

NCT01945216 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 3317

Last updated 2019-11-19

Study results available
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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.

Conditions

  • Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution

Interventions

DRUG

Alogliptin

Alogliptin tablets

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-08
Primary Completion
2015-10-31
Completion
2015-10-31

Countries

  • Japan

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01945216 on ClinicalTrials.gov