EUCTR2009-016178-33-PTActive, not recruitingNot Applicable
A Phase III, multicentre, international, randomised, parallel group, double blind cardiovascular safety study of BI 10773 (10 mg and 25 mg administered orally once daily) compared to usual care in type 2 diabetes mellitus patients with increased cardiovascular risk.
nilfarma, Lda.0 sites7,000 target enrollmentStarted: July 20, 2010Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 7,000
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Diagnosis of T2DM
- •2. Male and female patients on diet and exercise regimen who are drug-naïve or pre-treated with any background therapy.
- •3. HbA1c of = 7.0% and = 10% for patients on background therapy
- •4. HbA1c of = 7.0% and = 8.0% for drug-naïve patients.
- •5. Age =18 years
- •6. BMI = 45 kg/m2 at Visit 1 (Screening)
- •7. Signed and dated written informed consent (IC) by date of Visit 1
- •8. Patients must have high cardiovascular risk, defined as at least one of the following:
- •Confirmed history of myocardial infarction (>2 months prior to informed
- •Evidence of multivessel coronary artery disease, in 2 or more major coronary
- •arteries, irrespective of the revascularization, ie:
- •a) Either the presence of a significant stenosis (imaging evidence of at least 50% narrowing of the luminal diameter measured during a coronary angiography or a multi-sliced computed tomography angiography), in 2 or more major coronary arteries,
- •b) Or a previous revascularisation (percutaneous transluminal coronary angioplasty with or without stent, or coronary artery bypass grafting) at least 2 months ago, in 2 or more major coronary arteries,
- •c) Or the combination of previous revascularisation in one major
- •coronary artery at least 2 months ago (percutaneous transluminal
- •coronary angioplasty with or without stent, or coronary artery bypass
- •grafting), and the presence of a significant stenosis in another major
- •coronary artery (imaging evidence of at least 50% narrowing of the
- •luminal diameter measured during a coronary angiography or a multisliced
- •computed tomography angiography),
- •Note: A disease affecting the left main coronary artery is considered as a
- •2-vessel disease.
- •Evidence of a single vessel coronary artery disease with: a) The presence of a significant stenosis i.e. the imaging evidence of at least 50% narrowing of the luminal diameter of one major coronary artery in
- •patients not subsequently successfully revascularised (measured during a
- •coronary angiography or a multi-sliced computed tomography angiography)
- •b) And at least one of the following (either (i) or (ii)):
- •i. A positive non invasive stress test, confirmed by either:
- •1. A positive exercise tolerance test in patients without a complete
- •left bundle branch block, Wolff-Parkinson-White syndrome, or
- •paced ventricular rhythm, or
- •2. A positive stress echocardiography showing regional systolic
- •wall motion abnormalities, or
- •3. A positive scintigraphic test showing stress-induced ischemia, i.e.
- •the development of transient perfusion defects during myocardial
- •perfusion imaging;
- •ii. Or patient discharged from hospital with a documented diagnosis of
- •unstable angina within 12 months prior to selection
- •Last episode of unstable angina >2 months prior informed consent with
- •confirmed evidence of coronary multivessel or single vessel disease as
- •defined above.
- •History of ischemic or haemorrhagic stroke (>2 months prior to informed
- •Presence of peripheral artery disease (symptomatic or not) documented by either: previous limb angioplasty, stenting or bypass surgery; or previouslimb or foot amputation due to circulatory insufficiency; or angiographic evidence of significant (> 50%) peripheral artery stenosis in at least one limb; or evidence from a non-invasive measurement of significant (>50% or as reported as hemodynamically significant) peripheral artery stenosis in at least one limb; or ankle brachial index of < 0.9 in at least one limb.
Exclusion Criteria
- •1. Uncontrolled hyperglycaemia with a glucose level >240 mg/dl (>13.3 mmol/L) after an overnight fast during placebo run-in and confirmed by a second measurement
- •2. Indication of liver disease, defined by serum levels of either ALT (SGPT), AST (SGOT), or alkaline phosphatase above 3 x upper limit of normal (ULN) as determined during screening and/or run-in phase
- •3. Planned cardiac surgery or angioplasty within 3 months
- •4. Impaired renal function, defined as GFR<30 ml/min (MDRD formula) as determined during screening and/or run-in phase
- •5. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
- •6. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
- •7. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
- •8. Contraindications to background therapy according to the local label
- •9. Treatment with anti-obesity drugs 3 months prior to informed consent or any other treatment at the time of screening leading to unstable body weight
- •10. Current treatment with systemic steroids at time of IC or change in dosage of thyroid hormones within 6 weeks prior to IC or any other uncontrolled endocrine disorder except T2D
- •11. Pre-menopausal women (last menstruation =1 year prior to IC) who:
- •- are nursing or pregnant or
- •- are of child-bearing potential and are not practicing an acceptable method of birth control
- •12. Alcohol or drug abuse within the 3 months prior to IC
- •13. Intake of an investigational drug in another trial within 30 days prior to intake of study
- •medication in this trial or participating in another trial (involving an investigational drug
- •and/or follow-up)
- •14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
- •15. Acute coronary syndrome, stroke or TIA within 2 months prior to informed consent
Investigators
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