Phase 4
N=161
Efficacy and Safety Study of Pitavastatin Compared to atoRvastatin in Type 2 dIabeTes Mellitus With Hypercholesterolemia
Hypercholesterolemia With Type2DM
Bottom Line
View on ClinicalTrials.gov: NCT00889226 ↗Enrolled (actual)
161
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcome: Primary: Proportion of Patients Achieving LDL- C<100mg/dL — 61; 54 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Pitavastatin (Drug); Atorvastatin (Drug)
- Age
- Adult, Older Adult · 25+ yrs
- Sex
- All
- Sponsor
- JW Pharmaceutical
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patients Achieving LDL- C<100mg/dL |
61; 54 | — |
| SECONDARY The Change of LDL-C |
-69.8; -70.9 | — |
Summary
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia
Eligibility Criteria
Inclusion Criteria
- Age: 25yrs~75yrs
- Fasting TG Diagnosed Type2 DM, With OAD, HbA1c ≤ 10.0% or First Diagnosed Type2 DM, 6.5%≤HbA1c≤10.0%
Exclusion Criteria
- Type1 DM, Gestational diabetes
- Patient need to treat with Insulin
- Patient with operational treatment for severe diabetic complication
- Uncontrolled Hypothyroidism
- Unstable angina, MI, transient ischemic attack(TIA), Stroke, PCI, Heart Failure within 3 months (NYHA class4)
- Severe Hypertension (SBP ≥ 180 or DBP ≥ 110mmHg)
- Renal disorder (Serum creatinine ≥ 2.0mg/dL)
- Hepatic disorder (AST or ALT ≥ 2.5 X UNL)
- Creatinine Kinase > 2.5 X UNL
- Gravida or lactation phase
- Administration of Atorvastatin, Rosuvastatin, Pitavastatin
Data sourced from ClinicalTrials.gov (NCT00889226). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.