Clinical trial NCT05107063: An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes
Official title: A Multi-center, Prospective Observational Study to Investigate the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dyslipidemia Associated With Type II Diabetes Mellitus
Keywords: Dyslipidemia
Type II Diabetes Mellitus
Lead sponsor: Daiichi Sankyo
Sponsor class: INDUSTRY
Collaborators: name: Daiichi Sankyo Korea Co., Ltd.
First posted: 2021-11-04
Enrollment: 2972
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population included Korean dyslipidemic participants with Type 2 diabetes.

Brief summary: This study investigated the effectiveness of pravastatin on renal function in Korean dyslipidemic patients with Type 2 diabetes.

Detailed description: This survey study investigated the effect of routine initiation single dose of pravastatin (10 mg, 20 mg, or 40 mg) on renal function in Korean dyslipidemic patients with Type 2 diabetes. The study also examined the effect of pravastatin on lipid profiles, glucose metabolism, and safety.

Eligibility criteria: Inclusion Criteria:

* Participants with Type 2 diabetes (currently using an antidiabetic drug or satisfying diagnostic criteria of diabetes as defined by American Diabetes Association)
* Participants with dyslipidemia (currently using an antidyslipidemic drug or satisfying the Health Insurance Review \& Assessment Service insurance coverage treatment criteria\*) for whom drug treatment with pravastatin is confirmed
* Participants determined to be eligible as subjects at the discretion of the investigator
* Participants who voluntarily provided written consent using the Informed Consent Form on Use of Information

Exclusion Criteria:

* Participants who had administered pravastatin prior to study participation
* Participants with hypersensitivity to the investigational product or its history
* Participants with an active liver disease or persistent elevation of transaminase with an unknown cause
* Pregnant woman or women with childbearing potential, breastfeeding mothers
* Children
* Participants with severe hepatic or renal insufficiency
* Participants with myopathy
* Participants with cholestasis
* Participants with hypercholesterolemia due to hyperalphalipoproteinemia accompanied by HDL cholesterol elevation
* Participants with a genetic problem such as galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption

Primary outcomes:
measure: Percentage Change Rate From Baseline in the Modification of Diet in Renal Disease(MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration
timeFrame: Week 24 post-dose
Secondary outcomes:
measure: Change from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 24 After Routine Care of Pravastatin Administration
timeFrame: Week 24 post-dose
measure: Percentage Change Rate from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 48 After Routine Care of Pravastatin Administration
timeFrame: Week 12 and Week 48 post-dose
measure: Change from Baseline in Modification of Diet in Renal Disease (MDRD) Estimated Glomerular Filtration Rate (eGFR) at Week 12 and Week 48 after Routine Care of Pravastatin Administration
timeFrame: Week 12 and Week 48 post-dose
measure: Percentage Change Rate from Baseline in Estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) Formula at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration
timeFrame: Week 12, Week 24, and Week 48 post-dose
measure: Change from Baseline in Estimated Glomerular Filtration Rate (eGFR) using the Chronic Kidney Disease Epidemiology Collaboration(CKD-EPI) Formula at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration
timeFrame: Week 12, Week 24, and Week 48 post-dose
measure: Percentage Change Rate from Baseline in Total Cholesterol, Low Density Lipoprotein Cholesterol, High Density Lipoprotein-Cholesterol, Triglycerides, Fasting Plasma Glucose at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration
timeFrame: Week 12, Week 24, and Week 48 post-dose
measure: Change from Baseline in Total Cholesterol, Low Density Lipoprotein Cholesterol, High Density Lipoprotein-Cholesterol, Triglycerides, Fasting Plasma Glucose at Week 12, Week 24, and Week 48 After Routine Care of Pravastatin Administration
timeFrame: Week 12, Week 24, and Week 48 post-dose
measure: Percentage Change Rate from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration
timeFrame: Week 12, Week 24, and Week 48 post-dose
measure: Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration
timeFrame: Week 12, Week 24, and Week 48 post-dose
measure: Number of Participants With Treatment-emergent Adverse Events After Routine Care of Prevastatin Administration
timeFrame: Week 48 post-dose
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Korea University Ansan Hospital
city: Bucheon
country: Korea, Republic of
facility: The Catholic University of Korea, Bucheon St. Mary's Hospital
city: Busan
country: Korea, Republic of
facility: Yeongnam University Medical Center
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital - Site 23
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital - Site 26
city: Busan
country: Korea, Republic of
facility: Bong Seng Memorial Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital - Site 43
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital - Site 49
city: Busan
country: Korea, Republic of
facility: Kosin University Gospel Hospital
city: Changwon
country: Korea, Republic of
facility: Changwon Fatima Hospital
city: Cheonan
country: Korea, Republic of
facility: Soon Chun Hyang University Cheonan Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Daejeon
country: Korea, Republic of
facility: Eulji University DaeJeon Medical Center
city: Daejeon
country: Korea, Republic of
facility: Konyang University Hospital
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Goyang
country: Korea, Republic of
facility: National Health Insurance Service Ilsan Hospital
city: Goyang
country: Korea, Republic of
facility: Myongji Hospital
city: Gwangju
country: Korea, Republic of
facility: Chosun University Hospital
city: Gwangju
country: Korea, Republic of
facility: Gwangju Veterans Hospital
city: Incheon
country: Korea, Republic of
facility: Gachon University Gil Medical Center
city: Seongnam
country: Korea, Republic of
facility: Bundang CHA General Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Seoul
country: Korea, Republic of
facility: HANIL General Hospital
city: Seoul
country: Korea, Republic of
facility: Korea Cancer Center Hospital
city: Seoul
country: Korea, Republic of
facility: Eulji University Medical Center - Site 20
city: Seoul
country: Korea, Republic of
facility: Eulji University Medical Center - Site 52
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, St. Paul's Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Soon Chun Hyang University Seoul Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
city: Seoul
country: Korea, Republic of
facility: VHS Medical Center
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Chung-Ang Univerisity Hospital
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea, Yeouido St. Mary's Hospital
city: Suncheon
country: Korea, Republic of
facility: St. Carollo General Hospital
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital - Site 45
city: Suwon
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital - Site 50
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital - Site 04
city: Suwon
country: Korea, Republic of
facility: Ajou University Hospital - Site 05
city: Ulsan
country: Korea, Republic of
facility: Dongkang Medical Center
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital - Site 10
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University, Wonju Severance Christian Hospital - Site 15
Study officials:
affiliation: Daiichi Sankyo
name: Global Clinical Leader
role: STUDY_DIRECTOR
References: