CompletedNot Applicable

Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Combination Therapy With Thiazolidinediones"

1,374 participantsStarted 2011-03

Plain-language summary

The purpose of this study is to determine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and thiazolidinediones in patients with type 2 diabetes mellitus who failed to respond adequately to treatment with thiazolidinediones in addition to diet therapy and exercise therapy.

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
✕. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
✕. Patients with a history of hypersensitivity to any ingredient of Nesina

What they're measuring

Number of Participants Reporting One or More Adverse Drug Reactions

Timeframe: Baseline up to 12 months

Number of Participants Reporting One or More Serious Adverse Drug Reactions

Timeframe: Baseline up to 12 months

Trial details

NCT IDNCT01945242

SponsorTakeda

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-06

Results submitted2016-06-13

View on ClinicalTrials.gov More Type 2 Diabetes Melitus trials