Status:
COMPLETED
Acetyl-L-Carnitine in Type 2 Diabetes
Lead Sponsor:
Mario Negri Institute for Pharmacological Research
Collaborating Sponsors:
Leadiant Biosciences, Inc.
Conditions:
Diabetes Type 2
Hypertension
Eligibility:
All Genders
40-85 years
Phase:
PHASE3
Brief Summary
Decreased insulin sensitivity (or insulin resistance) is a major risk factor for type 2 diabetes mellitus and renal and cardiovascular disease. It is the key component and, possibly, a pathogenetic fa...
Detailed Description
BACKGROUND Arterial hypertension, in particular systolic hypertension, is a common component of the metabolic syndrome, a syndrome of hypertension, abdominal obesity, dyslipidemia, impaired glucose to...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Males and females \>40 years old;
- High-risk subjects with type 2 diabetes (WHO criteria);
- High blood pressure (systolic blood pressure \>140 mmHg or with concomitant antihypertensive treatment stable since at least 3 months);
- Serum creatinine concentration \<1.5 mg/dl;
- Patients legally able to give written informed consent to the trial (signed and dated by the patient);
- Written informed consent.
- Exclusion criteria:
- Uncontrolled diabetes (glycated hemoglobin \>11%);
- Acute cardiovascular events over the last 3 months;
- Specific contraindications or history of hypersensitivity to the study drugs;
- Previous history of allergy or intolerance, or evidence of immunologically-mediated renal disease, systemic diseases, cancer;
- Drug or alcohol abuse;
- Any chronic clinical conditions that may affect completion of the trial or confound data interpretation;
- Pregnancy or lactating;
- Women of childbearing potential without following a scientifically accepted form of contraception;
- Legal incapacity and/or other circumstances rendering the patient unable to understand the nature, scope and possible consequence of the trial;
- Evidence of an uncooperative attitude;
- Any evidence that patient will not be able to complete the trial follow-up.
Exclusion
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2012
Estimated Enrollment :
229 Patients enrolled
Trial Details
Trial ID
NCT00984750
Start Date
April 1 2008
End Date
December 1 2012
Last Update
February 25 2013
Active Locations (5)
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1
Hospital "Azienda Ospedaliera Ospedali Riunitidi Bergamo" Unit of Diabetology
Bergamo, Bergamo, Italy, 24100
2
Hospital "Azienda Ospedaliera di Treviglio e Caravaggio" Ambulatory of Diabetology
Ponte San Pietro, Bergamo, Italy, 24036
3
Clinical Research Center for Rare Diseases "Aldo and Cele Daccò"
Ranica, Bergamo, Italy, 24020
4
Hospital "Azienda Ospedaliera di Treviglio-Caravaggio"Unit of Diabetology and Metabolic Diseases
Romano di Lombardia, Bergamo, Italy