An Observational Study Investigating the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

Dyslipidemia Associated With Type II Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05107063
• Other study ID #: MVT-OS-15-01
• Status: Completed
• Start date: January 20, 2016
• Est. completion date: April 19, 2018

Study information

• Verified date: October 2021
• Source: Daiichi Sankyo, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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 information / eligibility

• Status: Completed
• Enrollment: 2972
• Est. completion date: April 19, 2018
• Est. primary completion date: April 19, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Dyslipidemia Associated With Type II Diabetes Mellitus
• Dyslipidemias

Intervention

Drug:
• Pravastatin
Routine initiation dose was 10 mg, 20 mg or 40 mg single dose once daily. Depending on patient response, dose could have been increased up to 40 mg. Maintenance dose was 10-40 mg once daily.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan
Korea, Republic of	The Catholic University of Korea, Bucheon St. Mary's Hospital	Bucheon
Korea, Republic of	Bong Seng Memorial Hospital	Busan
Korea, Republic of	Inje University Busan Paik Hospital - Site 23	Busan
Korea, Republic of	Inje University Busan Paik Hospital - Site 26	Busan
Korea, Republic of	Kosin University Gospel Hospital	Busan
Korea, Republic of	Pusan National University Hospital - Site 43	Busan
Korea, Republic of	Pusan National University Hospital - Site 49	Busan
Korea, Republic of	Yeongnam University Medical Center	Busan
Korea, Republic of	Changwon Fatima Hospital	Changwon
Korea, Republic of	Soon Chun Hyang University Cheonan Hospital	Cheonan
Korea, Republic of	Daegu Catholic University Medical Center	Daegu
Korea, Republic of	Eulji University DaeJeon Medical Center	Daejeon
Korea, Republic of	Konyang University Hospital	Daejeon
Korea, Republic of	GangNeung Asan Hospital	Gangneung
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang
Korea, Republic of	Inje University Ilsan Paik Hospital	Goyang
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	Gachon University Gil Medical Center	Incheon
Korea, Republic of	Bundang CHA General Hospital	Seongnam
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam
Korea, Republic of	Chung-Ang Univerisity Hospital	Seoul
Korea, Republic of	Eulji University Medical Center - Site 20	Seoul
Korea, Republic of	Eulji University Medical Center - Site 52	Seoul
Korea, Republic of	HANIL General Hospital	Seoul
Korea, Republic of	Kangdong Sacred Heart Hospital	Seoul
Korea, Republic of	Korea Cancer Center Hospital	Seoul
Korea, Republic of	Kyung Hee University Hospital at Gangdong	Seoul
Korea, Republic of	Samsung Medical Center	Seoul
Korea, Republic of	Seoul Medical Center	Seoul
Korea, Republic of	Soon Chun Hyang University Seoul Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, St. Paul's Hospital	Seoul
Korea, Republic of	The Catholic University of Korea, Yeouido St. Mary's Hospital	Seoul
Korea, Republic of	VHS Medical Center	Seoul
Korea, Republic of	Yonsei University Health System, Gangnam Severance Hospital	Seoul
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul
Korea, Republic of	St. Carollo General Hospital	Suncheon
Korea, Republic of	Ajou University Hospital - Site 04	Suwon
Korea, Republic of	Ajou University Hospital - Site 05	Suwon
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	Dongkang Medical Center	Ulsan
Korea, Republic of	Yonsei University, Wonju Severance Christian Hospital - Site 10	Wonju
Korea, Republic of	Yonsei University, Wonju Severance Christian Hospital - Site 15	Wonju

Sponsors (2)

Lead Sponsor	Collaborator
Daiichi Sankyo, Inc.	Daiichi Sankyo Korea Co., Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	Week 24 post-dose
Secondary	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	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)	Week 24 post-dose
Secondary	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	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)	Week 12 and Week 48 post-dose
Secondary	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	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)	Week 12 and Week 48 post-dose
Secondary	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	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)^a × 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, a 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.	Week 12, Week 24, and Week 48 post-dose
Secondary	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	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)^a × 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, a 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.	Week 12, Week 24, and Week 48 post-dose
Secondary	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	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]).	Week 12, Week 24, and Week 48 post-dose
Secondary	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	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]).	Week 12, Week 24, and Week 48 post-dose
Secondary	Percentage Change Rate from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration	Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.	Week 12, Week 24, and Week 48 post-dose
Secondary	Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration	Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.	Week 12, Week 24, and Week 48 post-dose
Secondary	Number of Participants With Treatment-emergent Adverse Events After Routine Care of Prevastatin Administration	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.	Week 48 post-dose