A Multi-center, Randomized, Active-controlled, Parallel Design, Low-Intervention Clinical Trial; Pitavastatin Comparing with Atorvastatin in Patients with Pre-Diabetes Mellitus and Hypercholesterolemia for evaluate the New Onset Diabetes Mellitus (PIANO-DM study)
- Conditions
- Endocrine, nutritional and metabolic disease
- Registration Number
- KCT0005394
- Lead Sponsor
- The Catholic University of Korea, Bucheon St. Mary's Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 706
1) Age 19~75 years as of the date of written consent 2)
Hypercholesterolemia Patients who need to treat with Pitavastatin or
Atorvastatin 3) Patients who meet the below cliteria -100 mg/dL = Fasting plasma
glucose (FPG) = 125 mg/dL or 5.7% = HbA1c = 6.4% - Triglyceride (TG)
< 400 mg/dL & Low density lipoprotein-cholesterol (LDL-C) 4) Patients who are
willing to participate in the Low-Intervention Clinical Trial and signed an
infromed consent document 5) Patients who are willing and able to adhere to the
prohibitions and restrictions specified in this protocol
1) Those with statin dosage within six months from the time
of screening (Visit 1) 2) A person whose medical history or surgical/procedural
has been verified: (1) Unstable angina occurring within 12 weeks from the time
of screening; myocardial infarction, routine ischemia, cerebrovascular disease
(e.g., stroke, cerebral infarction, cerebral hemorrhage, etc.) coronary bypass
or coronary interventions (2) Muscle disease, rhabdomyolysis (3) Alcohol or drug
abuse within one year from the time of screening (Visit 1) (4) Malicious tumors
within five years from the time of screening (Visit 1) 3) The following
accompanying diseases and laboratory tests are accompanied by abnormalities: (1)
FPG = 126 mg/dL or HbA1c = 6.5% (2) Systolic blood pressure (SBP) = 180
which is not controlled by medication mmHg or dynamic blood pressure (DBP) = 110
mmHg) (3) Thyroid-stimulating abnormalities that are not controlled by
medication hormone (TSH) = 2 X organ normal (ULN) or TSH < 0.5 X organ
normal, LLN (4) Creatine kinase (CK) = 2 X ULN (5) Serum creatinine = 2 X ULN
(6) Aspartate aminotransferase (AST) or Alan aminotransferase (ALT) = 3 X ULN
(7) Biliary obstruction or bile lump (8) Muscle disease 4) A person who is
administering cyclosporin, glycarprebir or fibrentasbir 5) Those who are
expected to take/take the following medication/food during the test period,
including the screening period (see 6.3.2 Prohibition and Prohibition for
details) (1) Pitavastatin or Atorvastatin and other lipid modulators (2) Any
other drug or food that may affect lipids in the blood; (3) Diabetes medicine
(but taboo before diabetes) (4) Any drug known to have drug interactions with
other Pitavastatin or Atorvastatin. 6) A person who has been given another test
medication or applied a medical device within 12 weeks from the time of
screening (Visit 1) 7) A person who is hypersensitive to Pitavastatin or
Atorvastatin or its constituent components. 8) Patients with digestive vaginosis
(cron disease, peptic ulcer, acute or chronic pancreatitis, etc.) that can
affect the absorption of Pitavastatin or Atorvastatin, or who have a history of
gastrointestinal surgery (except simple appendectomy or hernia surgery) 9)
Patients with genetic problems such as galactose intolerance, Lap lactase
deficiencies, or glucose-galactose malabsorbtion. 10) Pregnant women and men who
do not agree with the pregnant or breastfeeding and the proper contraception*. *
Contraception: 1.Inertation of intramuscular devices or intrauterine systems;
2.double-blocking (killers and condoms); contraceptive vaginal membrane, vaginal
sponge or cervical cap, 3. Infertility procedures (jerial joint surgery,
two-sided intubation, etc.) 11) Other test takers find it difficult to perform
the low-medium load test.
Study & Design
- Study Type
- Observational Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method ew Onset Diabetes Mellitus(%)
- Secondary Outcome Measures
Name Time Method Blood sugar and insulin secretion rate, lipid profile rate, target <br>LDL-C rate