UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047286 |
|---|---|
| Receipt number | R000053928 |
| Scientific Title | Efficacy of pitavastatin alone and in combination with ezetimibe on lipid profile in type II diabetes patients on biguanide therapy. |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2023/05/18 00:04:11 |
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Basic information
Public title
Efficacy of pitavastatin alone and in combination with ezetimibe on lipid profile in type II diabetes patients on biguanide therapy.
Acronym
Efficacy of pitavastatin alone and in combination with ezetimibe on lipid profile in type II diabetes patients on biguanide therapy.
Scientific Title
Efficacy of pitavastatin alone and in combination with ezetimibe on lipid profile in type II diabetes patients on biguanide therapy.
Scientific Title:Acronym
Efficacy of pitavastatin alone and in combination with ezetimibe on lipid profile in type II diabetes patients on biguanide therapy.
Region
| Asia(except Japan) |
Condition
Condition
Hyper(dys)lipidemia;Diabetes type II
Classification by specialty
| Hepato-biliary-pancreatic medicine | Endocrinology and Metabolism | Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of pitavastatin on lipid profile in type 2 diabetics on biguanide therapy.
Basic objectives2
Others
Basic objectives -Others
To compare the effects of pitavastatin alone and in combination with ezetimibe on elevated lipid levels in type II diabetics on biguanide therapy.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of effective lipid inhibitor(s) therapy in type II diabetics on biguanides.
Key secondary outcomes
Correlation between glycemic and lipid parameters and groups of drugs
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Patients taking metformin 500 mg BD
Interventions/Control_2
Patients taking metformin 500 mg BD, pitavastatin 4 mg OD
Interventions/Control_3
Patients taking metformin 500 mg BD, pitavastatin 2 mg OD and ezetimibe 10 mg OD
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 25 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
HbA1c>6.5%;patients on biguanide therapy; hyperlipidemia/dyslipidemia according to AHA guidelines; 30-65 years; both genders.
Key exclusion criteria
Pregnancy & lactation; patients on other drugs for diabetes type II or insulin; over 65 years of age; on antibiotics, calcium channel blockers or thyroxine; CKD,CLD or thyroid disease.
Target sample size
75
Research contact person
Name of lead principal investigator
| 1st name | Zehra |
| Middle name | Ghazal |
| Last name | Raza |
Organization
Bahria University
Division name
Bahria University of Health Sciences Campus Karachi
Zip code
75500
Address
Adjacent to PNS SHIFA, DHA Phase-II,Karachi,Pakistan
TEL
+923212477464
ghazalraza24@gmail.com
Public contact
Name of contact person
| 1st name | Zehra |
| Middle name | Ghazal |
| Last name | Raza |
Organization
Bahria University
Division name
Bahria University of Health Sciences
Zip code
75500
Address
Adjacent to PNS SHIFA, DHA Phase-II,Karachi,Pakistan
TEL
+923212477464
Homepage URL
ghazalraza24@gmail.com
Sponsor or person
Institute
BUHSC(K)
Institute
Department
Personal name
Dr. Zehra Ghazal Raza
Funding Source
Organization
Self or Principal Investigator
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Pakistani
Other related organizations
Co-sponsor
Setting: National Medical Center, PNS Shifa Hospital
Name of secondary funder(s)
NA
IRB Contact (For public release)
Organization
BUHSC(K)
Address
Adjacent to PNS SHIFA, DHA Phase-II, Karachi,Pakistan
Tel
+923212477464
ghazalraza24@gmail.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Bahria University of Health Sciiences, PNS Shifa Hospital (Karachi), NMC (Karachi)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 06 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000053928
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053928
Number of participants that the trial has enrolled
75
Results
This study proved that combination therapy of pitavastatin 2 mg and ezetimibe 10 mg did not show superior efficacy compared to therapy with pitavastatin 4 mg alone on lipid profile in type II diabetes. Even though the results were noticeable when means of all the parameters were compared, the difference between pre and post treatment numbers was not statistically significant.
Results date posted
| 2023 | Year | 05 | Month | 17 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Gender
Age
Fasting blood sugar
Glycosylated hemoglobin
Total cholesterol (TC)
Triglycerides (TG)
Low density lipoprotein (LDL-C)
High density lipoprotein (HDL-C)
Very low density lipoprotein (VLDL-C)
Non-HDL
TC-HDL Ratio
Participant flow
1. Patients who attend Internal Medicine Departments of NMC and PNS Shifa hospitals, diagnosed with Type II Diabetes and Hyper(dys)lipidemia.
2. Patients enrolled into the study based upon clinical assessment and study conditions.
3. Random allocation of subjects to group A (n= 25)
Random allocation of subjects to group B (n= 25)
Random allocation of subjects to group C (n= 25)
4. Analysis of group A before drug administration(n= 25)
Analysis of group B before drug administration(n= 25)
Analysis of group C before drug administration(n= 25)
5. Analysis of group A after drug administration(n= 25)
Analysis of group B after drug administration(n= 25)
Analysis of group C after drug administration(n= 25)
Adverse events
None reported
Outcome measures
Total cholesterol (TC),Triglycerides (TG),Low density lipoprotein (LDL-C),High density lipoprotein (HDL-C),Very low density lipoprotein (VLDL-C), Non-HDL,TC-HDL Ratio, Atherogenic index of plasma (AIP)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 21 | Day |
Date of IRB
| 2021 | Year | 12 | Month | 21 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 05 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 03 | Month | 25 | Day |
Last modified on
| 2023 | Year | 05 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053928
| Research Plan | |
|---|---|
| Registered date | File name |
| 2023/05/17 | Research Plan-Dr.Ghazal.docx |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2023/05/17 | case data specifications-Dr.Ghazal.docx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2023/05/18 | thesis.sav |
Single case data URL
Value
https://center6.umin.ac.jp/ice/53928
