| Trial ID: | L6043 |
| Source ID: | NCT00984750
|
| Associated Drug: |
Acetyl-L-Carnitine/Statin (Simvastatin)
|
| Title: |
Acetyl-L-Carnitine in Type 2 Diabetes
|
| Acronym: |
DIABASI
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Type 2|Hypertension
|
| Interventions: |
DRUG: acetyl-L-carnitine/statin (simvastatin)|DRUG: placebo
|
| Outcome Measures: |
Primary: Arterial blood pressure and dyslipidemia, Basal, 15th day, 30th day, 3rd and 6th month |
|
| Sponsor/Collaborators: |
Sponsor: Mario Negri Institute for Pharmacological Research | Collaborators: Leadiant Biosciences, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
229
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2008-04
|
| Completion Date: |
2012-12
|
| Results First Posted: |
|
| Last Update Posted: |
2013-02-25
|
| Locations: |
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Ambulatory of Diabetology, Ponte San Pietro, Bergamo, 24036, Italy|Clinical Research Center for Rare Diseases "Aldo and Cele Daccò", Ranica, Bergamo, 24020, Italy|Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases, Romano di Lombardia, Bergamo, Italy|Hospital "Azienda Ospedaliera di Treviglio-Caravaggio" Unit of Diabetology and Metabolic Disease, Treviglio, Bergamo, Italy|Hospital "Azienda Ospedaliera Ospedali Riunitidi Bergamo" Unit of Diabetology, Bergamo, 24100, Italy
|
| URL: |
https://clinicaltrials.gov/show/NCT00984750
|