A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Post Marketing Surveillance Protocol for Nesina® Tablet [Monotherapy or Combination Therapy in Type 2 Diabetic Patients]

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04980040
• Other study ID #: Alogliptin-6001
• Status: Completed
• Start date: April 19, 2014
• Est. completion date: August 30, 2019

Study information

• Verified date: March 2022
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The purpose of this study is to evaluate safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected in the precautions for use, ADRs already known, non-serious ADRs and other safety related information among participants who have received alogliptin for type 2 diabetes mellitus.

Description:

This is a long-term prospective, observational post-marketing surveillance study of alogliptin in participants with T2DM. The study assessed the safety and effectiveness of alogliptin for its approved indication within a real-world setting in South Korea.

The study will enroll approximately 3000 participants. The data is collected prospectively at the study sites and recorded in electronic case report forms (e-CRFs). All the participants are assigned to a single observational cohort:

• Nesina® Tablet

The multi-center study is conducted in South Korea. Data is collected at 13 and 26 weeks after enrollment during standard of care office visits. The overall study was conducted during re-examination period of approximately 5 years and 4 months.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3623
• Est. completion date: August 30, 2019
• Est. primary completion date: August 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

1. Had one of the following treatments with alogliptin for the first time as an adjunct to diet and exercise to improve glycemic control:

• Monotherapy with alogliptin

• Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with metformin or sulfonylurea or thiazolidinedione single therapy

• Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with thiazolidinedione and metformin combination therapy

• Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with insulin (single therapy or combination with metformin) therapy

• Combination therapy with metformin in patients who have no prior history of antidiabetic medication and may not achieve adequate glycemic control with monotherapy alogliptin

Exclusion Criteria:

1. Had alogliptin treatment outside of the locally approved label in Korea

2. Had a contraindication for the use of alogliptin (as described in the Korean product label)

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Alogliptin Benzoate
Alogliptin benzoate tablets

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Takeda

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Serious Adverse Events (SAEs)	An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method.	From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Primary	Percentage of Participants With Serious Adverse Drug Reactions (ADRs)	Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. An SAE is an adverse event resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. 95% Confidence Interval was calculated using exact method.	From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Primary	Percentage of Participants With Unexpected Adverse Events	An unexpected AE is an AE with a difference in nature, severity, specificity, or outcome, compared to the product licensure/safety notification of the drug. 95% Confidence Interval was calculated using exact method.	From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Primary	Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs)	Unexpected ADRs are unexpected AEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.	From first dose of study drug up to 30 days post last dose of study drug (Up to 79.77 weeks)
Secondary	Haemoglobin (HbA1c) Levels	HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.	Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
Secondary	Fasting Blood Glucose Levels		Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
Secondary	Percentage of Participants With HbA1c < 7.00%	HbA1c are glycated haemoglobin or amount of glucose attached to haemoglobin.	Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration
Secondary	Percentage of Participants With Overall Improvement and Final Effectiveness Assessment	Participants were assessed for overall improvement and effectiveness assessments as per the following categories: 'Improved - signs and symptoms are significantly improved'; 'Unchanged - improvement in signs and symptoms is not significant or there is no change in signs and symptoms'.	Up to Week 26