N/A
Completed N=1,026
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"
Source: ClinicalTrials.gov NCT03555565 ↗Enrolled (actual)
1,026
Serious AEs
0.4%
Results posted
Nov 2020
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Events — 5.93 Percentage of Participants
Summary
The purpose of this survey is to evaluate the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in type 2 diabetes mellitus patients with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more) in the routine clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Events |
5.93 | — |
| SECONDARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.259 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-12.08 | — |
| SECONDARY Change From Baseline in Fasting Insulin Level |
1.21 | — |
Eligibility Criteria
Inclusion Criteria
- Participants should meet one or more of the following:
- Have renal impairment (mild)
- Have hepatic impairment (mild or moderate)
- Elderly (aged 65 years or more)
Exclusion Criteria
- Participants with any contraindication for study drug.
Data sourced from ClinicalTrials.gov (NCT03555565). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.