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NCT Number: NCT05107063

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

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

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Key information

Conditions

Dyslipidemia Associated With Type II Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Korea University Ansan Hospital, Ansan, South Korea

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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

    Time frame: 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 outcomes

  1. 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

    Time frame: 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)

  2. 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

    Time frame: 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)

  3. 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

    Time frame: 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)

  4. 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

    Time frame: 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.

  5. 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

    Time frame: 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.

  6. 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

    Time frame: 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]).

  7. 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

    Time frame: 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]).

  8. Percentage Change Rate from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration

    Time frame: Week 12, Week 24, and Week 48 post-dose

    Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.

  9. Change from Baseline in Hemoglobin A1c (HbA1c) at Week 12, Week 24 and Week 48 After Routine Care of Pravastatin Administration

    Time frame: Week 12, Week 24, and Week 48 post-dose

    Blood plasma samples will be collected to assess hemoglobin A1c (HbA1c) (%)levels.

  10. Number of Participants With Treatment-emergent Adverse Events After Routine Care of Prevastatin Administration

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Daiichi Sankyo

Industry

Collaborators

  • Daiichi Sankyo Korea Co., Ltd.

Registry information

Official study title

A Multi-center, Prospective Observational Study to Investigate the Effectiveness of Pravastatin on Renal Function in Korean Dyslipidemic Patients With Type 2 Diabetes

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Nov 4, 2021
Registry last updated
Nov 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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