Alogliptin tablets special drug use surveillance: Mild type 2 diabetes mellitus
- Conditions
- Type 2 diabetes mellitus
- Registration Number
- JPRN-jRCT1080222234
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
This surveillance was conducted to examine the safety and efficacy of long-term Nesina therapy in patients with mild type 2 diabetes mellitus. The surveillance results raised no major concerns about the safety or efficacy of long-term Nesina therapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 19192
Patients with HbA1c (JDS value) less and equal 7.0% at the time of enrolment (within 3 months before initiation of Nesina therapy), regardless of the use of antidiabetic medication.
Patients contraindicated for Nesina
(1) Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
(2) Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
(3) Patients with a history of hypersensitivity to any ingredient of Nesina.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Percentage of Participants who had One or More Adverse Reactions<br>Time Frame: Up to Month 36<br><br>efficacy<br>Change from Baseline in Glycosylated Hemoglobin (HbA1c)<br>Time Frame: Baseline, and final assessment point (up to Month 36)
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from Baseline in Fasting Blood Glucose Level<br>Time Frame: Baseline, and final assessment point (up to Month 36)