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

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.

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Key information

Conditions

Type2 Diabetes

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Duvie(Lobeglitazone) tab 0.5mg

Drug

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

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

Primary outcomes

Incidence of major adverse events (AEs) and any AEs that occurred during the administration period of lobeglitazone

Time frame: during the administration period of lobeglitazone

Investigators identified the following as major AEs: edema, weight gain(in kilograms), fractures, bladder cancer, anemia, hypoglycemia, macular edema, cardiac death, myocardial Infarction, stroke, transient ischemic attack, coronary arterial occlusion, and CHF. Investigators also identified any AEs including blood pressure(in millimeter of mercury) change, increased liver enzyme (> 3X), and dizziness.

Secondary outcomes

Changes in glycated hemoglobin (HbA1c) and glucose, lipid parameters

Time frame: 3, 6, 12, 18, 24, 36, 42, and 48 months after administration of lobeglitazone

Investigators identified changes in glycated hemoglobin (HbA1c in percentage) and glucose(in milligrams per deciliter), lipid parameters in milligrams per deciliter(total cholesterol, triglyceride, low-density lipoprotein [LDL] cholesterol, and high-density lipoprotein [HDL] cholesterol) at 3, 6, 12, 18, 24, 36, 42, and 48 months after administration of lobeglitazone.

Sponsors and collaborators

Lead sponsor

Chong Kun Dang Pharmaceutical

Industry

Registry information

Acronym: DISCOVERY

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Sep 14, 2021
Registry last updated: Sep 14, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed