Retrospective Study to Evaluate the Safety of Duvie in Korean Patients With Type 2 Diabetes Mellitus

NCT ID: NCT05043467

Last Updated: 2021-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2228 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-02
• Study Completion Date: 2020-06-19

Brief Summary

Previous thiazolidinediones (TZDs) have issued various safety concerns including weight gain, bladder cancer, and congestive heart failure (CHF). This study aimed to evaluate the efficacy and safety of lobeglitazone, a novel TZD in patients with type 2 diabetes in real world.

Detailed Description

Lobeglitazone have clinical trials conducted in Korean type 2 diabetics patients for 6 months to up to 12 months, and the results of study on the efficacy and safety of lobeglitazone are relatively limited. In pre-marketing clinical trials, a controlled group of patients is enrolled to minimize other possible effects in determining the efficacy and safety of the drug.

Consequently, in real clinical practice, unexpectable safety information that has not been discovered at the pre-marketing stage may accur because it is more extensively and longer administered to a variety of patients who may have various underlying conditions and diseases. Therefore, there should be an ongoing assessment of safety information in real world. There have been the safety concerns of TZD, such as congestive heart failure (CHF), fractures, bladder cancer (long-term use), edema, and weight gain. Previous study has reported that lobeglitazone has better safety on bladder cancers and bone fractures than other TZDs, but currently, there is a lack of large-scaled, long-term safety and efficacy data of lobeglitazone in Korean real practice.

This is a non-interventional, multi-centered, retrospective and observational study and aimed to evaluate the efficacy and safety of lobeglitazone in patients with type 2 diabetes in real world.

Conditions

Type2 Diabetes

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: RETROSPECTIVE

Study Groups

Duvie(Lobeglitazone)

patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between February 1, 2014 and December 20, 2018

Duvie(Lobeglitazone) tab 0.5mg

Intervention Type: DRUG

patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between February 1, 2014 and December 20, 2018

Interventions

Duvie(Lobeglitazone) tab 0.5mg

patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between February 1, 2014 and December 20, 2018

Intervention Type: DRUG

Other Intervention Names

Chong Kun Dang Pharmaceutical, Duvie tab 0.5mg, code no.(643306610)

Eligibility Criteria

Inclusion Criteria

• patients with type 2 diabetes who received lobeglitazone 0.5mg for more than one year between February 1, 2014 and December 20, 2018

Exclusion Criteria

• patients who are not appropriate to participate in this research based on principal investigators' decision

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chong Kun Dang Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sung-Rae S Kim, M.D, PhD

Role: PRINCIPAL_INVESTIGATOR

Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St Mary's Hospital

Locations

Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St Mary's Hospital, College of Medicine, The Catholic University of Korea

Seoul, , South Korea

Countries

South Korea

Other Identifiers

59DM17022

Identifier Type: -

Identifier Source: org_study_id