Specified Drug-Use Survey of Alogliptin and Metformin Hydrochloride Combination Tablets Survey on long-term use in type 2 diabetes mellitus patients with renal or hepatic impairment or advanced age
Not Applicable
Completed
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- JPRN-jRCT1080223922
- Lead Sponsor
- Takeda Pharmaceutical Company Limited
- Brief Summary
The results above showed no new concerns regarding the long-term safety and efficacy of this drug in patients with type 2 diabetes mellitus with renal or hepatic impairment or advanced ages (>= 65 years) and suggested a relationship between the improvement in the medication adherence after switching medication to this product and efficacy in participants taking alogliptin benzoate and metformin hydrochloride in combination.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 1026
Inclusion Criteria
Participants should meet one or more of the following:
1. Have renal impairment (mild)
2. Have hepatic impairment (mild or moderate)
3. Elderly (aged 65 years or more)
Exclusion Criteria
Participants with any contraindication for study drug.
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 Events<br>Time Frame: Up to 12 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.
- Secondary Outcome Measures
Name Time Method efficacy<br>Change from Baseline in Glycosylated Hemoglobin (HbA1c)<br>Timeframe: Baseline, up to final assessment point (up to Month 12)<br>The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at final assessment point (up to Month 12) relative to baseline.<br><br><br>efficacy<br>Change from Baseline in Fasting Blood Glucose<br>Timeframe: Baseline, up to final assessment point (up to Month 12)<br>The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline.<br><br><br>efficacy<br>Change from Baseline in Fasting Insulin Level <br>Timeframe: Baseline, up to final assessment point (up to Month 12)<br>The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline.