Clinical trial NCT00123227 (phase 3, status: unknown status)
Conditions: diabetes mellitus, type 2, vascular diseases, hypertension
ICD codes: E11.65, E11.9, E11.21, E11.36, E11.41, E11.42, E11.44, I73.9, D57.03, D57.213, G46.8, I73.89, I15.0, I97.3, K76.6, P29.2, G93.2, H40.053, I10
Drugs: rosiglitazone
SMILES: CCN1C=C(C(O)=O)C(=O)C2=C1C=C(C=C2)C1=CC=NC=C1
Eligibility criteria:

        Inclusion Criteria:

          -  Patients with type 2 diabetes as defined by the World Health Organization (WHO)
             criteria

          -  Male or female patient who is 30 to 75 years of age at screening

          -  Patients with coexisting vascular disease (previous myocardial infarction,
             cerebrovascular accident or peripheral vascular disease) or hypertension (BP > 150/90)

          -  Patients who have initiated statin and fibrate therapy at least 6 months prior to
             screening, and have been receiving a stable dose for at least 3 months prior to
             screening. [Note: patients not receiving statin or fibrate therapy will be allowed to
             enter the study providing that this method of treatment is not required as active
             treatment for their medical condition at the time of screening; if any of these
             patients develop the need for statin or fibrate therapy during the course of the
             study, therapy will be started without the need to withdraw the patient from the
             study.]

          -  Female patients must be post-menopausal, surgically sterile, or using effective
             contraceptive measures. Women of childbearing age must use effective contraceptive
             measures for at least 1 month prior to visit 1 (screening), and should continue to use
             the same contraceptive method during the study and for 30 days after discontinuing
             study treatment.

          -  Patients who give their signed informed consent to participate.

          -  Patients with an HbA1c value < 10% at screening visit.

          -  Patients with evidence of at least one atheromatous plaque causing narrowing of
             internal carotid artery between 10 and 95%. Diagnosis to be performed prior to
             randomisation by colour duplex examination.

        Exclusion Criteria:

          -  Patients who have taken >2 concomitant oral anti-hypertensive agents (i.e. oral
             combination) within the 3 months prior to the screening visit (visit 1)

          -  Previous exposure to a thiazolidinedione (TZD) or other PPAR-gamma agonist (e.g.
             rosiglitazone, troglitazone, pioglitazone, GI262570) or participation in a
             double-blind clinical study involving a TZD or PPAR-gamma agonist where the
             randomisation code has not been broken prior to visit 1 (screening) of this study.

          -  Patients who have required the chronic use of insulin for glycaemic control at any
             time in the past (with the exception of those who have needed short-term insulin use
             to maintain glycaemic control during a hospitalisation, during pregnancy or during a
             medical procedure or intervention) or patients with a history of ketoacidosis.

          -  Use of any investigational drug within 30 days of 5 half-lives preceding the first
             dose of medication at the start of the study.

          -  Systolic blood pressure >170 mmHg or diastolic blood pressure > 100mHg.

          -  Patients with unstable or severe angina or congestive heart failure (New York Heart
             Association [NYHA] class I-IV)

          -  History of gangrene or transient ischaemic attack (TIA)

          -  History of stroke within the previous year.

          -  Presence of clinically significant hepatic disease (i.e. patients with ALT, total
             bilirubin, or alkaline phosphatase > 2.5 times the upper limit of the normal
             laboratory range)

          -  Any pre-existing condition or clinically significant abnormality identified in the
             screening (visit 1) physical examination, electrocardiogram, ultrasound examination or
             laboratory tests which, in the judgement of the investigator, would preclude safe
             completion of the study.

          -  Clinically significant anaemia defined by haemoglobin concentration <11g/dL for males,
             or <10 g/dL for females

          -  Patients with creatinine > 150 umol/L.

          -  Women who are lactating, pregnant, or planning to become pregnant during the course of
             the study.

          -  Alcohol or drug abuse within the last 6 months.

          -  Previous surgery to carotid arteries.

          -  Pacemakers, cerebral aneurysm clips, claustrophobia or any implantable devices
             incompatible with magnetic resonance imaging.

          -  Patients exhibiting total occlusion of the internal carotid artery (when assessed by
             colour duplex examination performed).

          -  Patients unable to lie supine for 60 minutes.