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Dyslipidemia Associated With Type II Diabetes MellitusNCT05107063

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

An observational study of Dyslipidemia Associated With Type II Diabetes Mellitus, run by Daiichi Sankyo at 47 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 years and older
What is being tested?
Pravastatin
How many people
2,972 participants
Where
47 sitesSouth Korea
Study dates
20 Jan 2016to 19 Apr 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

South Korea47 sites

  • Korea University Ansan Hospital

    Ansan, 15355

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

    Bucheon-si, 14647

  • Yeongnam University Medical Center

    Busan, 42415

  • Inje University Busan Paik Hospital - Site 23

    Busan, 47392

  • Inje University Busan Paik Hospital - Site 26

    Busan, 47392

  • Bong Seng Memorial Hospital

    Busan, 48775

  • Pusan National University Hospital - Site 43

    Busan, 49241

  • Pusan National University Hospital - Site 49

    Busan, 49241

  • Kosin University Gospel Hospital

    Busan, 49267

  • Changwon Fatima Hospital

    Changwon, 51394

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan, 31151

  • Daegu Catholic University Medical Center

    Daegu, 42472

  • Eulji University DaeJeon Medical Center

    Daejeon, 35233

  • Konyang University Hospital

    Daejeon, 35365

  • GangNeung Asan Hospital

    Gangneung, 25440

  • Dongguk University Ilsan Hospital

    Goyang, 10326

  • Inje University Ilsan Paik Hospital

    Goyang, 10380

  • National Health Insurance Service Ilsan Hospital

    Goyang, 10444

  • Myongji Hospital

    Goyang, 10475

  • Chosun University Hospital

    Gwangju, 61453

  • Gwangju Veterans Hospital

    Gwangju, 62284

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Bundang CHA General Hospital

    Seongnam, 13496

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • HANIL General Hospital

    Seoul, 01450

  • Korea Cancer Center Hospital

    Seoul, 01812

  • Eulji University Medical Center - Site 20

    Seoul, 01830

  • Eulji University Medical Center - Site 52

    Seoul, 01830

  • Seoul Medical Center

    Seoul, 02053

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

    Seoul, 02559

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722

  • Soon Chun Hyang University Seoul Hospital

    Seoul, 04401

  • Kyung Hee University Hospital at Gangdong

    Seoul, 05278

  • Kangdong Sacred Heart Hospital

    Seoul, 05355

  • VHS Medical Center

    Seoul, 05368

  • Yonsei University Health System, Gangnam Severance Hospital

    Seoul, 06273

  • Samsung Medical Center

    Seoul, 06351

  • Chung-Ang Univerisity Hospital

    Seoul, 06973

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

    Seoul, 07345

  • St. Carollo General Hospital

    Suncheon, 57931

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

    Suwon, 16247

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

    Suwon, 16247

  • Ajou University Hospital - Site 04

    Suwon, 16499

  • Ajou University Hospital - Site 05

    Suwon, 16499

  • Dongkang Medical Center

    Ulsan, 44455

  • Yonsei University, Wonju Severance Christian Hospital - Site 10

    Wŏnju, 26426

  • Yonsei University, Wonju Severance Christian Hospital - Site 15

    Wŏnju, 26426

Other trials in South Korea

About this study

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

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

Read the 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.

Being tested
Pravastatin
Keywords
Dyslipidemia, Type II Diabetes Mellitus
Medical subject headings
Dyslipidemias, Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PravastatinDrug

    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.

Study groups in NCT05107063
Study groupRoleWhat they receive
Dyslipidemic participants with Type 2 diabetesDyslipidemic 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.
Receives: Drug: Pravastatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Week 24 post-dose

Secondary outcomes (10)

  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

    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)

    Measured: Week 24 post-dose

  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

    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)

    Measured: Week 12 and Week 48 post-dose

  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

    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)

    Measured: Week 12 and Week 48 post-dose

  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

    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.

    Measured: Week 12, Week 24, and Week 48 post-dose

  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

    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.

    Measured: Week 12, Week 24, and Week 48 post-dose

  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

    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]).

    Measured: Week 12, Week 24, and Week 48 post-dose

  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

    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]).

    Measured: Week 12, Week 24, and Week 48 post-dose

  8. 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.

    Measured: Week 12, Week 24, and Week 48 post-dose

  9. 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.

    Measured: Week 12, Week 24, and Week 48 post-dose

  10. 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.

    Measured: Week 48 post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2021
  2. Study start20 Jan 2016
  3. Primary completion19 Apr 2018
  4. Study completion19 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,972 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05107063
Sponsor's protocol ID
MVT-OS-15-01
Status last verified
Oct 2021
First submitted
27 Oct 2021
Last updated
4 Nov 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38880822

Questions about this trial

What is this clinical trial studying?

An observational study of Dyslipidemia Associated With Type II Diabetes Mellitus, run by Daiichi Sankyo at 47 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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 (time frame: Week 24 post-dose). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05107063, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2021.

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