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

NCT05107063 | Completed FDA Drug

• 1 other identifier: MVT-OS-15-01
• Study Type: observational
• Target: 2,972
• Locations: 1 country
• Sites: 47

Brief Summary

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

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus

Keywords

Dyslipidemia; Type II Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• 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

• 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

• 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

• 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

• 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

Study Arms (1)

Dyslipidemic participants with Type 2 diabetes

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.

Drug: Pravastatin

Interventions

Pravastatin DRUG

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.

Dyslipidemic participants with Type 2 diabetes

Eligibility Criteria

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

Study Population

The study population included Korean dyslipidemic participants with Type 2 diabetes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Daiichi Sankyo: lead
• Daiichi Sankyo Korea Co., Ltd.: collaborator

Study Sites (47)

Korea University Ansan Hospital

Ansan, 15355, South Korea

Location

The Catholic University of Korea, Bucheon St. Mary's Hospital

Bucheon-si, 14647, South Korea

Location

Yeongnam University Medical Center

Busan, 42415, South Korea

Location

Inje University Busan Paik Hospital - Site 23

Busan, 47392, South Korea

Location

Inje University Busan Paik Hospital - Site 26

Busan, 47392, South Korea

Location

Bong Seng Memorial Hospital

Busan, 48775, South Korea

Location

Pusan National University Hospital - Site 43

Busan, 49241, South Korea

Location

Pusan National University Hospital - Site 49

Busan, 49241, South Korea

Location

Kosin University Gospel Hospital

Busan, 49267, South Korea

Location

Changwon Fatima Hospital

Changwon, 51394, South Korea

Location

Soon Chun Hyang University Cheonan Hospital

Cheonan, 31151, South Korea

Location

Daegu Catholic University Medical Center

Daegu, 42472, South Korea

Location

Eulji University DaeJeon Medical Center

Daejeon, 35233, South Korea

Location

Konyang University Hospital

Daejeon, 35365, South Korea

Location

GangNeung Asan Hospital

Gangneung, 25440, South Korea

Location

Dongguk University Ilsan Hospital

Goyang, 10326, South Korea

Location

Inje University Ilsan Paik Hospital

Goyang, 10380, South Korea

Location

National Health Insurance Service Ilsan Hospital

Goyang, 10444, South Korea

Location

Myongji Hospital

Goyang, 10475, South Korea

Location

Chosun University Hospital

Gwangju, 61453, South Korea

Location

Gwangju Veterans Hospital

Gwangju, 62284, South Korea

Location

Gachon University Gil Medical Center

Incheon, 21565, South Korea

Location

Bundang CHA General Hospital

Seongnam, 13496, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, 13620, South Korea

Location

HANIL General Hospital

Seoul, 01450, South Korea

Location

Korea Cancer Center Hospital

Seoul, 01812, South Korea

Location

Eulji University Medical Center - Site 20

Seoul, 01830, South Korea

Location

Eulji University Medical Center - Site 52

Seoul, 01830, South Korea

Location

Seoul Medical Center

Seoul, 02053, South Korea

Location

The Catholic University of Korea, St. Paul's Hospital

Seoul, 02559, South Korea

Location

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

Location

Soon Chun Hyang University Seoul Hospital

Seoul, 04401, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, 05278, South Korea

Location

Kangdong Sacred Heart Hospital

Seoul, 05355, South Korea

Location

VHS Medical Center

Seoul, 05368, South Korea

Location

Yonsei University Health System, Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

Samsung Medical Center

Seoul, 06351, South Korea

Location

Chung-Ang Univerisity Hospital

Seoul, 06973, South Korea

Location

The Catholic University of Korea, Yeouido St. Mary's Hospital

Seoul, 07345, South Korea

Location

St. Carollo General Hospital

Suncheon, 57931, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital - Site 45

Suwon, 16247, South Korea

Location

The Catholic University of Korea, St. Vincent's Hospital - Site 50

Suwon, 16247, South Korea

Location

Ajou University Hospital - Site 04

Suwon, 16499, South Korea

Location

Ajou University Hospital - Site 05

Suwon, 16499, South Korea

Location

Dongkang Medical Center

Ulsan, 44455, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital - Site 10

Wŏnju, 26426, South Korea

Location

Yonsei University, Wonju Severance Christian Hospital - Site 15

Wŏnju, 26426, South Korea

Location

Related Publications (1)

• Kim HJ, Hur KY, Lee YH, Kim JT, Lee YK, Baek KH, Choi EJ, Hwang WM, Bang KT, Lim JS, Chung YJ, Jo SR, Oh JS, Lee SH, Ko SH, Choi SH. Effect of Pravastatin on Kidney Function in Patients with Dyslipidemia and Type 2 Diabetes Mellitus: A Multicenter Prospective Observational Study. Adv Ther. 2024 Aug;41(8):3119-3137. doi: 10.1007/s12325-024-02862-5. Epub 2024 Jun 16.

  PMID: 38880822 DERIVED

MeSH Terms

Conditions

Dyslipidemias; Diabetes Mellitus, Type 2

Interventions

Pravastatin

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Global Clinical Leader

  Daiichi Sankyo

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 4, 2021
• Study Start: January 20, 2016
• Primary Completion: April 19, 2018
• Study Completion: April 19, 2018
• Last Updated: November 4, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

KR (47)