BI 10773 add-on to Usual Care Compared With Usual Care Alone in Patients With Type 2 Diabetes Mellitus at High Cardiovascular Risk
- Conditions
- Health Condition 1: null- Diabetes Mellitus, Type 2Cardiovascular Risk
- Registration Number
- CTRI/2011/05/001725
- Lead Sponsor
- Boehringer Ingelheim Pharmaceuticals
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 4000
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.
3. HbA1c of ≥7.0% and ≤ 10% for patients on background therapy or HbA1c ≥7.0% and ≤8.0% for drug-naïve patients.
4. Age ≥18 years and ≤ 65 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:
? History of myocardial infarction (2 months prior to informed consent)
? Unstable angina (2 months prior informed consent) with documented multivessel coronary disease (of at least two major coronary arteries in angiogram) or positive stress test (ST segment depression ≥2 mm or a positive nuclear perfusion scintigram).
? Multivessel Percutaneous Coronary Intervention (PCI) 2 months prior informed consent
? Multivessel Coronary Artery By-pass Grafting (CABG) 4 years prior to informed consent or with recurrent angina following surgery
? History of ischemic or hemorrhagic stroke (2 months prior to informed consent)
? Peripheral occlusive arterial disease (previous limb bypass surgery or percutaneous transluminal angioplasty; previous limb or foot amputation due
to circulatory insufficiency, angiographic or ultrasound detected significant vessel stenosis (50% stenosis) of major limb arteries)
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 GFR30 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
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: CV death (including fatal stroke and fatal MI), non-fatal MI and non-fatal stroke.Timepoint: 4.5 years
- Secondary Outcome Measures
Name Time Method The composite of all events adjudicated: cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction, non-fatal stroke and hospitalization for unstable angina pectoris.Timepoint: 4 years;To determine the incidence of microalbuminuria and the progression of microalbuminuria to macroalbuminuria from baseline to end of trial.Timepoint: 4 years;To determine the incidence of silent MITimepoint: 4 years