Type 2 diabetes mellitus MedDRA version: 9.1 Level: LLT Classification code 10053246 Term: Type II diabetes peripheral angiopathy
Conditions
Interventions
Trade Name: Reyataz
Pharmaceutical Form: Capsule*
INN or Proposed INN: atazanavir
CAS Number: 229975-97-7
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Pharm
Sponsors
RUNMC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - At least 18 and not older than 65 years of age on the day of the first dosing. - Type 2 diabetes mellitus treated with diet, oral medication and/or insulin. - Subject has a Quetelet Index (Body Mass Index) of 18 to 30 kg/m2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Documented history of sensitivity/idiosyncrasy to medicinal products or excipients. - History of smoking within the past year - History of or current abuse of drugs, alcohol or solvents. - Current use of antihypertensive, cardiac or other vasoactive medication. - Current use of acetylsalicylic acid - Use of antioxidant vitamin supplements - Use of acid suppressive medication - Inability to suspend the use of statins during trial participation - Clinical evidence of cardiac or pulmonary disease - Laboratory evidence of renal or hepatic abnormalities, defined as results exceeding twice the upper limit of normal range. - Cardiac conduction abnormalities, consisting of a 2nd degree atrioventricular block or a complex bundle branch block. - Subjects with Gilbert Syndrome, which is suggested by an unconjucated hyperbilirubinemia (total bilirubin level above 10 µmol/L and a normal direct bilirubin level) and has to be confirmed by genetic testing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study the influence of atazanavir induced hyperbilirubinemia on endothelial dysfunction related to type 2 diabetes.;Secondary Objective: To study the influence of atazanavir induced hyperbilirubinemia on markers of vascular inflammation related to type 2 diabetes.;Primary end point(s): Forearm vasodilatory response to increasing doses of intra-arterially administered acetylcholine, serotonin and nitroglycerine (three doses each) following treatment with both atazanavir and placebo. | — |
Countries
Netherlands
Outcome results
None listed