Specified Drug-Use Survey of Trelagliptin Tablets Survey on long-term use in patients with type 2 diabetes mellitus
Not Applicable
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT1080223923
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
o new safety or efficacy concerns were observed with the long-term treatment with this drug of participants with type 2 diabetes mellitus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 3198
Inclusion Criteria
Type 2 diabetes mellitus patients
Exclusion Criteria
1. Have severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus
2. Have severe infection, perioperative status, or serious trauma
3. Have severe renal impairment or on dialysis due to end-stage renal disease
4. Have a history of hypersensitivity to any ingredients of this drug
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Number of Participants Who Had One or More Adverse Events<br>Timeframe; 36 months<br>An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.<br>safety<br>Number of Participants Who Had One or More Adverse Drug Reactions<br>Timeframe; 36 months<br>An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug.
- Secondary Outcome Measures
Name Time Method