BI 10773 Cardiovascular Outcomes Trial in Type 2 Diabetes Mellitus Patients
- Conditions
- Diabetes Mellitus, Type 2
- Registration Number
- SLCTR/2011/008
- Lead Sponsor
- Boehringer Ingelheim India Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- Not specified
1. Diagnosis of type 2 diabetes mellitus prior to informed consent
2. Male and female patients on diet and exercise regimen who are drug-naïve or pre-treated with any background therapy. Antidiabetic therapy has to be unchanged for 12 weeks prior to randomization. If insulin is part of the background therapy, the insulin total daily prescribed dose should not be chaged within the 12 weeks prior to randomisation by more than 10% daily from the baseline value at randomisation
3. HbA1c of ?7.0% and ?10% at Visit 1 (screening) for patients on background therapy or HbA1c of ?7.0% and ? 9.0% At Visit 1 (screening) for drug-naïve patients.
4. Age ?18 years
5. BMI ?45 kg/m2 (Body Mass Index) at Visit 1 (Screening)
6. Signed and dated written informed consent by date of Visit 1 in accordance with GCP and local legislation.
7. In addition to the above described criteria, patients must have high cardiovascular risk, defined as at least one of the following: • Confirmed history of myocardial infarction (>2 months prior to informed consent) • Evidence of multivessel coronary artery disease, in 2 or more major coronary arteries, irrespective of the revascularization status, i.e. 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 multi-sliced 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 consent) • Presence of peripheral artery disease (symptomatic or not ) documented
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 (not on the same day)
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 (severe renal impairment, 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 (e.g., sibutramine, orlistat) 3 months prior to informed consent or any other treatment at the time of screening (i.e., surgery, aggressive diet regimen, etc.) leading to unstable body weight
10. Current treatment with systemic steroids at time of informed consent or change in dosage of thyroid hormones within 6 weeks prior to informed consent or any other uncontrolled endocrine disorder except T2DM
11. Pre-menopausal women (last menstruation ? 1 year prior to informed consent) who:
- are nursing or pregnant or - are of child-bearing potential and are not practicing an acceptable method of birth control, or do not plan to continue using this method throughout the study and do not agree to submit to periodic pregnancy testing during participation in the trial. Acceptable methods of birth control include tubal ligation, transdermal patch, intra uterine devices/systems (IUDs/IUSs), oral, implantable or injectable contraceptives, sexual abstinence (if allowed by local Authorities), double barrier method and vasectomised partner
12. Alcohol or drug abuse within the 3 months prior to informed consent that would interfere with trial participation or any ongoing condition leading to a decreased compliance to study procedures or study drug intake
13. Participation in another trial with an investigational drug within 30 days prior to informed consent
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary endpoint is time to the first occurrence of any of the following adjudicated components of the primary composite endpoint: cardiovascular death (including fatal stroke and fatal myocardial infarction(MI)), non-fatal MI and non-fatal stroke [Time Frame: 4 years]<br>
- Secondary Outcome Measures
Name Time Method The composite of all events adjudicated: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatalmyocardial infarctionI, non-fatal stroke and hospitalization for unstable angina pectoris. <br> [Time Frame: 4 years]<br>To determine the incidence of microalbuminuria and the progression of microalbuminuria to macroalbuminuria from baseline to end of trial. <br> [Time Frame: 4 years]<br>To determine the incidence of silent MI [Time Frame: 4 years]<br>