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

Sponsor
Daiichi Sankyo, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT05107063
Collaborator
Daiichi Sankyo Korea Co., Ltd. (Industry)
2,972
Enrollment
47
Locations
26.9
Actual Duration (Months)
63.2
Patients Per Site
2.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

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.

Study Design

Study Type:
Observational
Actual Enrollment :
2972 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Jan 20, 2016
Actual Primary Completion Date :
Apr 19, 2018
Actual Study Completion Date :
Apr 19, 2018

Arms and Interventions

Arm Intervention/Treatment
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
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.

Outcome Measures

Primary Outcome Measures

  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 [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

  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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Korea University Ansan Hospital Ansan Korea, Republic of 15355
2 The Catholic University of Korea, Bucheon St. Mary's Hospital Bucheon Korea, Republic of 14647
3 Yeongnam University Medical Center Busan Korea, Republic of 42415
4 Inje University Busan Paik Hospital - Site 23 Busan Korea, Republic of 47392
5 Inje University Busan Paik Hospital - Site 26 Busan Korea, Republic of 47392
6 Bong Seng Memorial Hospital Busan Korea, Republic of 48775
7 Pusan National University Hospital - Site 43 Busan Korea, Republic of 49241
8 Pusan National University Hospital - Site 49 Busan Korea, Republic of 49241
9 Kosin University Gospel Hospital Busan Korea, Republic of 49267
10 Changwon Fatima Hospital Changwon Korea, Republic of 51394
11 Soon Chun Hyang University Cheonan Hospital Cheonan Korea, Republic of 31151
12 Daegu Catholic University Medical Center Daegu Korea, Republic of 42472
13 Eulji University DaeJeon Medical Center Daejeon Korea, Republic of 35233
14 Konyang University Hospital Daejeon Korea, Republic of 35365
15 GangNeung Asan Hospital Gangneung Korea, Republic of 25440
16 Dongguk University Ilsan Hospital Goyang Korea, Republic of 10326
17 Inje University Ilsan Paik Hospital Goyang Korea, Republic of 10380
18 National Health Insurance Service Ilsan Hospital Goyang Korea, Republic of 10444
19 Myongji Hospital Goyang Korea, Republic of 10475
20 Chosun University Hospital Gwangju Korea, Republic of 61453
21 Gwangju Veterans Hospital Gwangju Korea, Republic of 62284
22 Gachon University Gil Medical Center Incheon Korea, Republic of 21565
23 Bundang CHA General Hospital Seongnam Korea, Republic of 13496
24 Seoul National University Bundang Hospital Seongnam Korea, Republic of 13620
25 HANIL General Hospital Seoul Korea, Republic of 01450
26 Korea Cancer Center Hospital Seoul Korea, Republic of 01812
27 Eulji University Medical Center - Site 20 Seoul Korea, Republic of 01830
28 Eulji University Medical Center - Site 52 Seoul Korea, Republic of 01830
29 Seoul Medical Center Seoul Korea, Republic of 02053
30 The Catholic University of Korea, St. Paul's Hospital Seoul Korea, Republic of 02559
31 Yonsei University Health System, Severance Hospital Seoul Korea, Republic of 03722
32 Soon Chun Hyang University Seoul Hospital Seoul Korea, Republic of 04401
33 Kyung Hee University Hospital at Gangdong Seoul Korea, Republic of 05278
34 Kangdong Sacred Heart Hospital Seoul Korea, Republic of 05355
35 VHS Medical Center Seoul Korea, Republic of 05368
36 Yonsei University Health System, Gangnam Severance Hospital Seoul Korea, Republic of 06273
37 Samsung Medical Center Seoul Korea, Republic of 06351
38 Chung-Ang Univerisity Hospital Seoul Korea, Republic of 06973
39 The Catholic University of Korea, Yeouido St. Mary's Hospital Seoul Korea, Republic of 07345
40 St. Carollo General Hospital Suncheon Korea, Republic of 57931
41 The Catholic University of Korea, St. Vincent's Hospital - Site 45 Suwon Korea, Republic of 16247
42 The Catholic University of Korea, St. Vincent's Hospital - Site 50 Suwon Korea, Republic of 16247
43 Ajou University Hospital - Site 04 Suwon Korea, Republic of 16499
44 Ajou University Hospital - Site 05 Suwon Korea, Republic of 16499
45 Dongkang Medical Center Ulsan Korea, Republic of 44455
46 Yonsei University, Wonju Severance Christian Hospital - Site 10 Wŏnju Korea, Republic of 26426
47 Yonsei University, Wonju Severance Christian Hospital - Site 15 Wŏnju Korea, Republic of 26426

Sponsors and Collaborators

  • Daiichi Sankyo, Inc.
  • Daiichi Sankyo Korea Co., Ltd.

Investigators

  • Study Director: Global Clinical Leader, Daiichi Sankyo, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier:
NCT05107063
Other Study ID Numbers:
  • MVT-OS-15-01
First Posted:
Nov 4, 2021
Last Update Posted:
Nov 4, 2021
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Daiichi Sankyo, Inc.
Dyslipidemia
Type II Diabetes Mellitus
Additional relevant MeSH terms:
Diabetes Mellitus
Dyslipidemias
Diabetes Mellitus, Type 2
Pravastatin

Study Results

No Results Posted as of Nov 4, 2021