A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea

NCT04980014 | Completed Results

• 1 other identifier: Alogliptin-Pio-5002
• Study Type: observational
• Target: 730
• Locations: 1 country
• Sites: 8

Brief Summary

The purpose of this post marketing surveillance (PMS) study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) in participants who are treated for type 2 diabetes mellitus under NesinaAct® tablet therapy (alogliptin/pioglitazone) once daily by physicians in the real-world clinical practice setting over a period of 26 weeks.

Conditions

Type 2 Diabetes Mellitus

Keywords

Drug Therapy

Outcome Measures

Primary Outcomes (9)

• Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)

  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. Serious ADRs are defined as SAEs that are, in the investigator's opinion, of causal relationship to the study treatment. 95% Confidence Interval was calculated using exact method.

  First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)

• Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions

  An AE is any and all undesirable or unintended signs (including abnormal clinical laboratory values), symptoms, or disease that are incurred when the drug is administered, and is not related to causal relationship with the drug. An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. An unexpected ADR is an ADR with difference in the nature or severity, specificity, or the outcome, compared to the product licensure/notification of the drug. 95% Confidence Interval was calculated using exact method.

  First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)

• Percentage of Participants With Expected/Already Known ADRs at Week 13

  An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.

  Week 13

• Percentage of Participants With Expected/Already Known ADRs at Week 26

  An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.

  Week 26

• Percentage of Participants With Expected/Already Known ADRs at Week 39

  An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.

  Week 39

• Percentage of Participants With Expected/Already Known ADRs at Week 52

  An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.

  Week 52

• Percentage of Participants With Expected/Already Known ADRs at Week 153

  An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. Expected/already known ADRs are those listed in product licensure/notification of the drug. Data is reported as per duration of study drug treatment for this outcome measure from administration start date to AE onset date. 95% Confidence Interval was calculated using exact method.

  Week 153

• Percentage of Participants With Non-serious ADRs

  An ADR is a harmful and unintended reaction resulting from usual administration and use of the drug, whose causal relationship with the drug cannot be excluded, and if causal relationship with the drug is unknown among AEs reported spontaneously, it is regarded as ADR. 95% Confidence Interval was calculated using exact method.

  First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)

• Percentage of Participants With Abnormal Laboratory Findings Reported as AEs

  Presence and absence of significant data in laboratory results were recorded. 95% Confidence Interval was calculated using exact method.

  First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)

Secondary Outcomes (8)

• Change From Baseline in Haemoglobin A1c (HbA1c) Levels

  Baseline, Weeks 13 and 26

• Change From Baseline in Fasting Serum Glucose

  Baseline, Weeks 13 and 26

• Change From Baseline in Total Cholesterol

  Baseline, Weeks 13 and 26

• Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)

  Baseline, Weeks 13 and 26

• Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)

  Baseline, Weeks 13 and 26

Study Arms (1)

NesinaAct® Tablet

Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, are observed in this study.

Drug: NesinaAct® Tablet

Interventions

NesinaAct® Tablet DRUG

NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.

NesinaAct® Tablet

Eligibility Criteria

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

Study Population

Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

You may qualify if:

• Participants inadequately controlled on diet and exercise.
• Participants inadequately controlled on metformin alone.
• Participants inadequately controlled on pioglitazone alone.
• Participants inadequately controlled on metformin and pioglitazone combination therapy.
• Participants switching from alogliptin co-administered with pioglitazone.

You may not qualify if:

• Participants treated with study drug outside of the locally approved label in Korea.
• Participants with contraindication for the use of study drug (as described in the Korean product label).

Sponsors & Collaborators

• Takeda: lead

Study Sites (8)

Unknown Facility

Busan, South Korea

Location

Unknown Facility

Chuncheon, South Korea

Location

Unknown Facility

Daejeon, South Korea

Location

Unknown Facility

Gangneung-si, South Korea

Location

Unknown Facility

Goyang-si, South Korea

Location

Unknown Facility

Jeonju, South Korea

Location

Unknown Facility

Seongam, South Korea

Location

Unknown Facility

Seoul, South Korea

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Study 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: October 2, 2015
• Primary Completion: August 30, 2019
• Study Completion: August 30, 2019
• Last Updated: March 7, 2022
• Results First Posted: March 7, 2022

Record last verified: 2021-12

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 (8)