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

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.

Study Overview

• Status: Completed
• Conditions: Type2 Diabetes
• Intervention / Treatment: Drug: Duvie(Lobeglitazone) tab 0.5mg

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.

• Study Type: Observational
• Enrollment (Actual): 2228

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All the patients who satisfy the inlusion and exclusion criteria

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Drug: 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; Other Names: Chong Kun Dang Pharmaceutical, Duvie tab 0.5mg, code no.(643306610)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of major adverse events (AEs) and any AEs that occurred 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.	during the administration period of lobeglitazone

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in glycated hemoglobin (HbA1c) and glucose, lipid parameters	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.	3, 6, 12, 18, 24, 36, 42, and 48 months after administration of lobeglitazone

Collaborators and Investigators

• Sponsor: Chong Kun Dang Pharmaceutical
• Investigators: Principal Investigator: Sung-Rae S Kim, M.D, PhD, Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St Mary's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2019
• Primary Completion (Actual): June 19, 2020
• Study Completion (Actual): June 19, 2020

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 12, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): September 14, 2021
• Last Update Submitted That Met QC Criteria: September 12, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 59DM17022

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No