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

NCT05043467 | Completed DMC

• 1 other identifier: 59DM17022
• Study Type: observational
• Target: 2,228
• Locations: 1 country
• Sites: 1

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.

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

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

Study Arms (1)

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

Interventions

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

Also known as: Chong Kun Dang Pharmaceutical, Duvie tab 0.5mg, code no.(643306610)

Duvie(Lobeglitazone)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All the patients who satisfy the inlusion and exclusion criteria

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Chong Kun Dang Pharmaceutical: lead

Study Sites (1)

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

Location

MeSH Terms

Interventions

Tablets

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• Sung-Rae S Kim, M.D, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2021
• First Posted: September 14, 2021
• Study Start: January 2, 2019
• Primary Completion: June 19, 2020
• Study Completion: June 19, 2020
• Last Updated: September 14, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)