An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes
- Conditions
- Dyslipidemia Associated With Type II Diabetes Mellitus
- Interventions
- Registration Number
- NCT05107063
- Lead Sponsor
- Daiichi Sankyo
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2972
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Dyslipidemic participants with Type 2 diabetes Pravastatin Dyslipidemic participants with Type 2 diabetes who received a routine initiation dose of pravastatin 10 mg, 20 mg or 40 mg single dose once daily and maintained a low cholesterol diet throughout the study period.
- Primary Outcome Measures
Name Time Method 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 Week 24 post-dose The following formula was used to calculate MDRD eGFR:
MDRD eGFR (mL/min/1.73 m\^2) = 186 x (serum creatinine) -1.154 x (age)-0.203 x (0.742 if female)
- Secondary Outcome Measures
Name Time Method 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 Week 12 and Week 48 post-dose The following formula was used to calculate MDRD eGFR:
MDRD eGFR (mL/min/1.73 m\^2) = 186 x (serum creatinine)\^-1.154 x (age)\^-0.203 x (0.742 if female)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 Week 24 post-dose The following formula was used to calculate MDRD eGFR:
MDRD eGFR (mL/min/1.73 m\^2) = 186 x (serum creatinine)\^-1.154 x (age)\^-0.203 x (0.742 if female)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 Week 12 and Week 48 post-dose The following formula was used to calculate MDRD eGFR:
MDRD eGFR (mL/min/1.73 m\^2) = 186 x (serum creatinine)\^-1.154 x (age)\^-0.203 x (0.742 if female)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 Week 12, Week 24, and Week 48 post-dose The following formula was used to calculate CKD-EPI eGFR:
CKD-EPI eGFR (mL/min/1.73 m\^2) = 141 × min (serum creatinine/k, 1)\^α × max (serum creatinine/k, 1)\^-1.209 × 0.993\^(age) × 1.018 (if female), where k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates minimum serum creatinine/k or 1, and max indicates maximum serum creatinine/k or 1.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 Week 12, Week 24, and Week 48 post-dose Blood plasma samples will be collected to assess lipids (total cholesterol \[mg/dL\], low density lipoprotein cholesterol (LDL-C) \[mg/dL\], high density lipoprotein-cholesterol (HDL-C) \[mg/dL\], triglyceride \[mg/dL\], and fasting plasma glucose \[mg/dL\]).
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 Week 12, Week 24, and Week 48 post-dose The following formula was used to calculate CKD-EPI eGFR:
CKD-EPI eGFR (mL/min/1.73 m\^2) = 141 × min (serum creatinine/k, 1)\^α × max (serum creatinine/k, 1)\^-1.209 × 0.993\^(age) × 1.018 (if female), where k is 0.7 for females and 0.9 for males, α is -0.329 for females and -0.411 for males, min indicates minimum serum creatinine/k or 1, and max indicates maximum serum creatinine/k or 1.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 Week 12, Week 24, and Week 48 post-dose Blood plasma samples will be collected to assess lipids (total cholesterol \[mg/dL\], low density lipoprotein cholesterol (LDL-C) \[mg/dL\], high density lipoprotein-cholesterol (HDL-C) \[mg/dL\], triglyceride \[mg/dL\], and fasting plasma glucose \[mg/dL\]).
Percentage Change Rate from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration Week 12, Week 24, and Week 48 post-dose Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.
Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration Week 12, Week 24, and Week 48 post-dose Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.
Number of Participants With Treatment-emergent Adverse Events After Routine Care of Prevastatin Administration Week 48 post-dose Treatment-emergent adverse event (TEAE) is defined as an event that emerges during treatment, having been absent pretreatment, or worsens relative to the pretreatment state.
Trial Locations
- Locations (47)
Dongguk University Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Daegu Catholic University Medical Center
🇰🇷Daegu, Korea, Republic of
HANIL General Hospital
🇰🇷Seoul, Korea, Republic of
Bundang CHA General Hospital
🇰🇷Seongnam, Korea, Republic of
Inje University Busan Paik Hospital - Site 23
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital - Site 49
🇰🇷Busan, Korea, Republic of
The Catholic University of Korea, St. Paul's Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System, Gangnam Severance Hospital
🇰🇷Seoul, Korea, Republic of
Chung-Ang Univerisity Hospital
🇰🇷Seoul, Korea, Republic of
Ajou University Hospital - Site 05
🇰🇷Suwon, Korea, Republic of
GangNeung Asan Hospital
🇰🇷Gangneung, Korea, Republic of
The Catholic University of Korea, Yeouido St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Eulji University Medical Center - Site 20
🇰🇷Seoul, Korea, Republic of
Soon Chun Hyang University Seoul Hospital
🇰🇷Seoul, Korea, Republic of
Kyung Hee University Hospital at Gangdong
🇰🇷Seoul, Korea, Republic of
Changwon Fatima Hospital
🇰🇷Changwon, Korea, Republic of
Eulji University DaeJeon Medical Center
🇰🇷Daejeon, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
Korea University Ansan Hospital
🇰🇷Ansan, Korea, Republic of
Ajou University Hospital - Site 04
🇰🇷Suwon, Korea, Republic of
Soon Chun Hyang University Cheonan Hospital
🇰🇷Cheonan, Korea, Republic of
Dongkang Medical Center
🇰🇷Ulsan, Korea, Republic of
VHS Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University, Wonju Severance Christian Hospital - Site 15
🇰🇷Wŏnju, Korea, Republic of
Eulji University Medical Center - Site 52
🇰🇷Seoul, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital - Site 45
🇰🇷Suwon, Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital - Site 50
🇰🇷Suwon, Korea, Republic of
Yeongnam University Medical Center
🇰🇷Busan, Korea, Republic of
The Catholic University of Korea, Bucheon St. Mary's Hospital
🇰🇷Bucheon, Korea, Republic of
Konyang University Hospital
🇰🇷Daejeon, Korea, Republic of
Inje University Busan Paik Hospital - Site 26
🇰🇷Busan, Korea, Republic of
Myongji Hospital
🇰🇷Goyang, Korea, Republic of
National Health Insurance Service Ilsan Hospital
🇰🇷Goyang, Korea, Republic of
Chosun University Hospital
🇰🇷Gwangju, Korea, Republic of
Gwangju Veterans Hospital
🇰🇷Gwangju, Korea, Republic of
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Korea Cancer Center Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei University Health System, Severance Hospital
🇰🇷Seoul, Korea, Republic of
Kangdong Sacred Heart Hospital
🇰🇷Seoul, Korea, Republic of
St. Carollo General Hospital
🇰🇷Suncheon, Korea, Republic of
Samsung Medical Center
🇰🇷Seoul, Korea, Republic of
Yonsei University, Wonju Severance Christian Hospital - Site 10
🇰🇷Wŏnju, Korea, Republic of
Kosin University Gospel Hospital
🇰🇷Busan, Korea, Republic of
Bong Seng Memorial Hospital
🇰🇷Busan, Korea, Republic of
Pusan National University Hospital - Site 43
🇰🇷Busan, Korea, Republic of
Seoul Medical Center
🇰🇷Seoul, Korea, Republic of