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A single center, randomized, open-label, active comparator-controlled, parallel-group trial ＆#8211； 24 weeks explanatory pilot study

Status Approved

First Submitted Date

2019/07/08
Registered Date

2019/07/16
Last Updated Date

2019/07/11

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CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

1. Background

Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
CRIS Registration Number	KCT0004143
Unique Protocol ID	KHNMC 2018-11-015-002
Public/Brief Title	Comparison of Effects of Statin Monotherapy and Statin / Ezetimibe Combination Therapy on Blood Glucose Metabolism in Type 2 Diabetic Patients with Hyperlipidemia
Scientific Title	A single center, randomized, open-label, active comparator-controlled, parallel-group trial ＆#8211； 24 weeks explanatory pilot study
Acronym
MFDS Regulated Study	No
IND/IDE Protocol	No
Registered at Other Registry	No
Healthcare Benefit Approval Status	Not applicable

2. Institutional Review Board / Ethics Committee

Institutional Review Board Information
Board Approval Status	Submitted approval
Board Approval Number	KHNMC 2018-11-015-002
Approval Date	2019-04-04
Institutional Review Board Name	Institutional Review Board of Kyung Hee University Hospital at Gangdong
Institutional Review Board Address	892, Dongnam-ro, Gangdong-gu, Seoul
Institutional Review Board Telephone	02-440-8107
Data Monitoring Committee

3. Contact Details

Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
Contact Person for Principal Investigator / Scientific Queries
Name	You-Cheol Hwang
Title	Professor
Telephone	+82-2-440-6283
Affiliation	Kyung Hee University Hospital at Gangdong
Address	892, Dongnam-ro,Gangdong-gu, Seoul
Contact Person for Public Queries
Name	junghwa lee
Title	coordinator
Telephone	+82-2-440-7058
Affiliation	Kyung Hee University Hospital at Gangdong
Address	892, Dongnam-ro,Gangdong-gu, Seoul
Contact Person for Updating Information
Name	junghwa lee
Title	coordinator
Telephone	+82-2-440-7058
Affiliation	Kyung Hee University Hospital at Gangdong
Address	892, Dongnam-ro,Gangdong-gu, Seoul

4. Status

Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
Recruitment Status by Participating Study Site 1
Study Site	Single
Overall Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-07-22 Anticipated
Target Number of Participant	48
Primary Completion Date	2020-07-01 , Anticipated
Study Completion Date	2020-12-31 , Anticipated
Name of Study	Kyung Hee University Hospital at Gangdong
Recruitment Status	Not yet recruiting
Date of First Enrollment	2019-07-22 ,

5. Source of Monetary / Material Support

Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
1. Source of Monetary/Material Support
Organization Name	Daewoong
Organization Type	Pharmaceutical Company
Project ID

6. Sponsor Organization

Sponsor Organization Information - Organization Name, Organization Type
1. Sponsor Organization
Organization Name	Kyung Hee University Hospital at Gangdong
Organization Type	Medical Institute

7. Study Summary

Study Summary Information
Lay Summary	Objective: Low-dose statin / ezetimibe rosuvastatin 5mg + ezetimibe 10mg (CRETEJETE) is similar to rosuvastatin 20mg (high-dose statin monotherapy) in LDL-cholesterol-lowering therapy, but does not increase glycosylated hemoglobin. Background: It is very common for diabetics to take statins, and current guidelines recommend that low-density lipoprotein cholesterol be lowered to less than 70 mg / dl through high-intensity statins. Therefore, there is a need for a strategy to prevent the occurrence of cardiovascular disease by reducing cholesterol without adversely affecting long - term metabolism. METHODS: Patients were randomly assigned to one of two clinical trial drugs and compared for changes in glycated hemoglobin after 24 weeks.

Study Summary Information

Lay Summary

Objective: Low-dose statin / ezetimibe rosuvastatin 5mg + ezetimibe 10mg (CRETEJETE) is similar to rosuvastatin 20mg (high-dose statin monotherapy) in LDL-cholesterol-lowering therapy, but does not increase glycosylated hemoglobin. 
Background: It is very common for diabetics to take statins, and current guidelines recommend that low-density lipoprotein cholesterol be lowered to less than 70 mg / dl through high-intensity statins. Therefore, there is a need for a strategy to prevent the occurrence of cardiovascular disease by reducing cholesterol without adversely affecting long - term metabolism.
METHODS: Patients were randomly assigned to one of two clinical trial drugs and compared for changes in glycated hemoglobin after 24 weeks.

8. Study Design

Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
Study Type	Interventional Study
Study Purpose	Treatment
Phase	Not applicable
Intervention Model	Parallel
Blinding/Masking	Double
Blinded Subject	Subject, Investigator
Allocation	RCT
Intervention Type	Drug
Intervention Description	Low-dose statin / ezetimibe rosuvastatin 5mg + ezetimibe 10mg (CRETEJETE) is similar to rosuvastatin 20mg (high-dose statin monotherapy) in LDL-cholesterol-lowering therapy, but does not increase glycosylated hemoglobin. One tablet is given once a day for 24 weeks.
Number of Arms	2
Arm 1	Arm Label crezet 5/10mg(rosuvastatin 5mg + ezetimibe 10mg)
	Target Number of Participant 24
	Arm Type Experimental
	Arm Description Total 24 weeks, once a day, one tablet
Arm 2	Arm Label rosuvastatin 20mg
	Target Number of Participant 24
	Arm Type Active comparator
	Arm Description Total 24 weeks, twice a day, one tablet

9. Subject Eligibility

Subject Eligibility Information
Condition(s)/Problem(s)	* (E00-E90)Endocrine, nutritional and metabolic diseases (E11.9)Type 2 diabetes mellitus, without complications Diabetes Mellitus, Type 2
Rare Disease	No
Inclusion Criteria	Gender Both
	Age 20Year~No Limit
	Description 1) patients over 20 years old with type 2 diabetes 2) Those who are under the control of blood glucose control by lifestyle therapy or metformin alone. 3) Diagnosis of diabetes less than 10 years 4) When registering HbA1c ≤ 8.0% 5) LDL cholesterol ≥ 70 mg / dl 6) Those who have agreed with the written consent of the subject for participation in clinical trials
Exclusion Criteria	1) Those who took a lipid lowering agent for more than a week within the last 3 months 2) Those who took a lipid lowering agent for more than one day in the past month 3) Within 3 months, major cardiovascular disease 4) Those who are taking medication for weight loss or who are scheduled 5) Those who are taking or are planning to take drugs that affect the metabolism of sugar, such as systemic steroids 6) Serum AST, ALT Upper Normal Limit more than 2 times 7) Serum creatinine> 1.5 mg / dl 8) Untreated hyperthyroidism, hypothyroidism 9) Triglyceride ≥ 500 mg / dl 10) Malignant tumor under treatment 11) Pregnancy 12) Any person deemed unable to participate in research under the judgment of the researcher
Healthy Volunteers	No

10. Outcome Measure(s)

Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
Primary Outcome(s) 1
Type of Primary Outcome	Efficacy
Outcome	Compare HbA1C changes
Timepoint	12 weeks, 24 weeks
Secondary Outcome(s) 1
Outcome	Comparison of fasting blood sugar change
Timepoint	12 weeks, 24 weeks
Secondary Outcome(s) 2
Outcome	Comparison of insulin change
Timepoint	24 weeks
Secondary Outcome(s) 3
Outcome	Comparison of glucagon change
Timepoint	24 weeks
Secondary Outcome(s) 4
Outcome	Comparison of HOMA-B change
Timepoint	24 weeks
Secondary Outcome(s) 5
Outcome	Comparison of insulinogenic index change
Timepoint	24 weeks
Secondary Outcome(s) 6
Outcome	Comparison of disposition index change
Timepoint	24 weeks
Secondary Outcome(s) 7
Outcome	Comparison of HOMA-IR change
Timepoint	24 weeks
Secondary Outcome(s) 8
Outcome	Comparison of Matsuda index change
Timepoint	24 weeks
Secondary Outcome(s) 9
Outcome	Comparison of Stumvoll index change
Timepoint	24 weeks
Secondary Outcome(s) 10
Outcome	Comparison of OGIS index change
Timepoint	24 weeks
Secondary Outcome(s) 11
Outcome	Comparison of LDL cholesterol change
Timepoint	12 weeks, 24 weeks
Secondary Outcome(s) 12
Outcome	Comparison of Non-HDL cholesterol change
Timepoint	12 weeks, 24 weeks
Secondary Outcome(s) 13
Outcome	Comparison of ApoB change
Timepoint	12 weeks, 24 weeks
Secondary Outcome(s) 14
Outcome	Comparison of ApoB/Apo-A1 change
Timepoint	12 weeks, 24 weeks
Secondary Outcome(s) 15
Outcome	Comparison of High-sensitivity CRP change
Timepoint	12 weeks, 24 weeks

11. Study Results and Publication

Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
Result Registered	No

12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
Sharing Statement	No

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