NCT00506961

Evaluate the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Type 2 Diabetic Patients With Dyslipidemia

A Phase IV, Randomized, Open-label, Parallel-arm, Comparative and Forced- Titration Study to Compare the Efficacy and Safety of Rosuvastatin Versus Simvastatin in Patients With Type 2 DM and Dyslipidemia

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 90 (actual)
• Sponsor: Taipei Veterans General Hospital, Taiwan · Other Government
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a phase IV, randomized, open-label, parallel-arm, comparative and forced- titration study to compare the efficacy and safety of rosuvastatin versus simvastatin in patients with type 2 DM and dyslipidemia. When comparing the efficacy of rosuvastatin 20 mg with simvastatin 40 mg for the treatment of type 2 DM with dyslipidemia, rosuvastatin 20 mg is superior to simvastatin 40 mg in achieving the combined goal of LDL-C (\<100 mg/dL) and non-HDL-C (\<130 mg/dL).

Detailed description

The duration of patient participation will be 18 weeks consisting of a 1-week screening period, a 5-week lead-in period, followed by a 12-week treatment period.

Conditions

• Diabetes Mellitus
• Dyslipidemia

Interventions

Type	Name	Description
DRUG	Rosuvastatin	10 mg rosuvastatin for 4 weeks followed by rosuvastatin or another 12 weeks
DRUG	Simvastatin	20 mg simvastatin for 4 weeks followed by 40 mg simvastatin for another 8 weeks

Timeline

• Start date: 2006-06-01
• Primary completion: 2007-07-01
• Completion: 2007-07-01
• First posted: 2007-07-25
• Last updated: 2011-12-06

Locations

2 sites across 1 country: Taiwan