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"

Type 2 Diabetes Mellitus Clinical Trial

Official 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"

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03555565
• Other study ID #: Alogliptin-Met-5003
• Secondary ID: JapicCTI-183979
• Status: Completed
• Start date: February 28, 2017
• Est. completion date: October 31, 2019

Study information

• Verified date: August 2023
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

The drug being tested in this survey is called alogliptin and metformin hydrochloride combination tablet. This tablet is being tested to treat people who have type 2 diabetes mellitus with renal impairment (mild), hepatic impairment (mild or moderate), or advanced age (65 years and more).

This survey is an observational (non-interventional) study and will look at the long-term safety and efficacy of the alogliptin and metformin hydrochloride combination tablet in the routine clinical setting. The planned number of observed patients will be approximately 600.

This multi-center observational trial will be conducted in Japan.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1026
• Est. completion date: October 31, 2019
• Est. primary completion date: October 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Alogliptin and Metformin hydrochloride
Alogliptin and Metformin hydrochloride combination tablets

Locations

Country	Name	City	State
Japan	Takeda Selected Site	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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)
Secondary	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)
Secondary	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)