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

NCT04980040 | Completed Results

• 1 other identifier: Alogliptin-6001
• Study Type: observational
• Target: 3,623
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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)

• 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 Outcomes (4)

• Haemoglobin (HbA1c) Levels

  Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration

• Fasting Blood Glucose Levels

  Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration

• Percentage of Participants With HbA1c < 7.00%

  Baseline (Before administration of alogliptin), 13 weeks (±2 weeks) and 26 weeks (±2 weeks) after administration

• Percentage of Participants With Overall Improvement and Final Effectiveness Assessment

  Up to Week 26

Study Arms (1)

Nesina® Tablet

Participants with a diagnosis of Type 2 Diabetes who took Nesina® tablet (alogliptin), as prescribed by the physician, are observed in this study.

Drug: Alogliptin Benzoate

Interventions

Alogliptin Benzoate DRUG

Alogliptin benzoate tablets

Also known as: Nesina® Tablet

Nesina® Tablet

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants diagnosed with type 2 diabetes mellitus are observed.

You may qualify if:

• \. 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

You may not qualify if:

• Had alogliptin treatment outside of the locally approved label in Korea
• Had a contraindication for the use of alogliptin (as described in the Korean product label)

Sponsors & Collaborators

• Takeda: lead

Study Sites (22)

Unknown Facility

Andong, South Korea

Location

Unknown Facility

Anyang-si, South Korea

Location

Unknown Facility

Bucheon-si, South Korea

Location

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Daegu, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gimhae, South Korea

Location

Unknown Facility

Gongju, South Korea

Location

Unknown Facility

Goyang-si, South Korea

Location

Unknown Facility

Gwangju, South Korea

Location

Unknown Facility

Gyeongju, South Korea

Location

Unknown Facility

Incheon, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Namyangju, South Korea

Location

Unknown Facility

Osan, South Korea

Location

Unknown Facility

Seongnam, South Korea

Location

Unknown Facility

Seongnam-si, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Suncheon, South Korea

Location

Unknown Facility

Suwon, South Korea

Location

Unknown Facility

Ulsan, South Korea

Location

Unknown Facility

Wŏnju, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

alogliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Medical Director
• Organization: Takeda

trialdisclosures@takeda.com

+1 877-825-3327

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

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: July 26, 2021
• First Posted: July 28, 2021
• Study Start: April 19, 2014
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: April 5, 2022
• Results First Posted: April 5, 2022

Record last verified: 2022-03

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.

Locations

KR (22)