The Effect of Rosuvastatin in Diabetic Polyneuropathy: A Phase IIa Randomized Double-blind Placebo-controlled Study
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT01622777 |
Recruitment Status :
Completed
First Posted : June 19, 2012
Last Update Posted : June 20, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diabetic Polyneuropathy | Drug: Rosuvastatin Drug: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 34 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Phase IIa Randomized Double-blind Placebo-controlled Study to Evaluate the Effect of Rosuvastatin in Diabetic Polyneuropathy |
Study Start Date : | February 2010 |
Actual Primary Completion Date : | January 2011 |
Actual Study Completion Date : | June 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: Rosuvastatin
20 mg daily of oral rosuvastatin
|
Drug: Rosuvastatin
20 mg daily of oral rosuvastatin for 12 weeks |
Placebo Comparator: Placebo |
Drug: Placebo
100 mg of oral placebo with identical appearance, form and size than rosuvastatin, one tablet daily for 12 weeks |
- Stage of diabetic polyneuropathy [ Time Frame: 12 weeks ]
- Severity of diabetic polyneuropathy [ Time Frame: 12 weeks ]Severity according nerve conduction studies
- Nerve conduction studies [ Time Frame: 12 weeks ]
- Neuropathy symptoms and impairment scores [ Time Frame: 12 weeks ]
- Lipid peroxidation [ Time Frame: 12 weeks ]
- Nerve growth factor [ Time Frame: 12 weeks ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 35 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01622777
Mexico | |
Cardiovascular Research Unit. University of Guadalajara. | |
Guadalajara, Jalisco, Mexico, 44340 |
Study Director: | Ernesto G. Cardona-Muñoz, MD, PhD | University of Guadalajara | |
Study Chair: | Luis Miguel Roman-Pintos, MD,PhD | University of Guadalajara | |
Study Chair: | Rogelio Troyo-Sanroman, PhD | University of Guadalajara | |
Study Chair: | María del Pilar Alatorre-Carranza, PhD | Hospital Civil de Guadalajara | |
Study Director: | Alejandra G. Miranda-Diaz, MD, PhD | University of Guadalajara | |
Principal Investigator: | Jaime Hernandez-Ojeda, MD, PhD | University of Guadalajara |
Responsible Party: | Alejandra Guillermina Miranda Diaz, Investigator of Cardiovascular Research Unit, University of Guadalajara |
ClinicalTrials.gov Identifier: | NCT01622777 |
Other Study ID Numbers: |
ROSU001 |
First Posted: | June 19, 2012 Key Record Dates |
Last Update Posted: | June 20, 2012 |
Last Verified: | June 2012 |
Rosuvastatin Diabetic polyneuropathy Nerve conduction Oxidative stress Nerve growth factor |
Polyneuropathies Diabetic Neuropathies Peripheral Nervous System Diseases Neuromuscular Diseases Nervous System Diseases Diabetes Complications Diabetes Mellitus Endocrine System Diseases |
Rosuvastatin Calcium Anticholesteremic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents Hydroxymethylglutaryl-CoA Reductase Inhibitors Enzyme Inhibitors |