Trial | NCT01622777  Report issue

Title

The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study
Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    rosuvastatin ...

  • Study Participants

    34
To evaluate the impact of oral rosuvastatin in diabetic polyneuropathy, and the role of lipid peroxidation and nerve growth factor.
Study Started
Feb 28
2010
Primary Completion
Jan 31
2011
Study Completion
Jun 30
2011
Last Update
Jun 20
2012
Estimate

Drug Rosuvastatin

20 mg daily of oral rosuvastatin for 12 weeks

Drug Placebo

100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks

Rosuvastatin Experimental

20 mg daily of oral rosuvastatin

Placebo Placebo Comparator

Criteria 

Inclusion Criteria:

Patients with type 2 diabetes mellitus
Glycated hemoglobin <12.0%
Signing of informed consent
Presence of an abnormality of nerve conduction study
Symptoms and signs of diabetic polyneuropathy

Exclusion Criteria:

Pregnancy and lactation
Foot ulcers
Treatment with statins
Antioxidant drug and/or supplements one month previous to enrolment
Inability to mobilize
Renal and/or hepatic failure
No Results Posted