| Trial ID: | L3162 |
| Source ID: | NCT03555565
|
| Associated Drug: |
Alogliptin And Metformin Hydrochloride
|
| Title: |
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"
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT03555565/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Alogliptin and Metformin hydrochloride
|
| Outcome Measures: |
Primary: Percentage of Participants Who Had One or More Adverse Events, 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., Up to 12 months | Secondary: Change From Baseline in Glycosylated Hemoglobin (HbA1c), 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., Baseline, up to final assessment point (up to Month 12)|Change From Baseline in Fasting Blood Glucose, The change in the value of fasting blood glucose collected at final assessment point (up to Month 12) relative to baseline., Baseline, up to final assessment point (up to Month 12)|Change From Baseline in Fasting Insulin Level, The change in the value of fasting insulin collected at final assessment point (up to Month 12) relative to baseline., Baseline, up to final assessment point (up to Month 12)
|
| Sponsor/Collaborators: |
Sponsor: Takeda
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
1026
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2017-02-28
|
| Completion Date: |
2019-10-31
|
| Results First Posted: |
2020-11-23
|
| Last Update Posted: |
2023-09-13
|
| Locations: |
Takeda Selected Site, Tokyo, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT03555565
|
