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"
2 other identifiers
observational
1,026
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2017
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 28, 2017
CompletedFirst Submitted
Initial submission to the registry
June 1, 2018
CompletedFirst Posted
Study publicly available on registry
June 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
October 31, 2019
CompletedResults Posted
Study results publicly available
November 23, 2020
CompletedSeptember 13, 2023
August 1, 2023
2.7 years
June 1, 2018
October 29, 2020
August 29, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Blood Glucose
Baseline, up to final assessment point (up to Month 12)
Change From Baseline in Fasting Insulin Level
Baseline, up to final assessment point (up to Month 12)
Study Arms (1)
Alogliptin and Metformin hydrochloride
Alogliptin 25 mg and metformin hydrochloride 500 mg, combination tablet, orally, once daily for up to 12 months. Participants received interventions as part of routine medical care.
Interventions
Alogliptin and Metformin hydrochloride combination tablets
Eligibility Criteria
Patients with type 2 diabetes mellitus for whom combination therapy with alogliptin and metformin hydrochloride is appropriate in the opinion of a physician as the routine medical care.
You may qualify if:
- 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)
You may not qualify if:
- Participants with any contraindication for study drug.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (1)
Takeda Selected Site
Tokyo, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Takeda (Note: This product was divested to Teijin Pharma Limited in 2023)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 1, 2018
First Posted
June 13, 2018
Study Start
February 28, 2017
Primary Completion
October 31, 2019
Study Completion
October 31, 2019
Last Updated
September 13, 2023
Results First Posted
November 23, 2020
Record last verified: 2023-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.