Clinical trial NCT05043467: Retrospective Study to Evaluate the Safety of Duvie in Korean Patients With Type 2 Diabetes Mellitus
Official title: Retrospective Study to Evaluate the Safety of Duvie in Korean Patients With Type 2 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type2 Diabetes
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-09-14
Enrollment: 2228
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients who satisfy the inlusion and exclusion criteria

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.

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

Primary outcomes:
measure: Incidence of major adverse events (AEs) and any AEs that occurred during the administration period of lobeglitazone
timeFrame: during the administration period of lobeglitazone
Secondary outcomes:
measure: Changes in glycated hemoglobin (HbA1c) and glucose, lipid parameters
timeFrame: 3, 6, 12, 18, 24, 36, 42, and 48 months after administration of lobeglitazone
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St Mary's Hospital, College of Medicine, The Catholic University of Korea
Study officials:
affiliation: Division of Endocrinology and Metabolism, Department of Internal Medicine, Bucheon St Mary's Hospital
name: Sung-Rae S Kim, M.D, PhD
role: PRINCIPAL_INVESTIGATOR
References: