None listed
Conditions
Interventions
Group 1 Type of group
10 mg of BI 10773 orally
Group name:Group 3 Type of group
placebo similar to the study product by mouth
Sponsors
Boehringer Ingelheim,
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: • Diagnosis of T2DM • Male and female patients on diet and exercise regimen who are drug-naïve or pre-treated with any background therapy. • HbA1c of = 7.0% and = 10% for patients on background therapy • HbA1c = 8.0% for drug-naïve patients. • Age >18 years • BMI = 45 kg/m2 at Visit 1 (Screening) • Signed and dated written informed consent (IC) by date of Visit 1 • Patients must have high cardiovascular risk, defined as at least one of the following: History of myocardial infarction (> 3 months prior to IC), Unstable angina (> 30 days prior IC), Multivessel Percutaneous Coronary Intervention (PCI) > 30 days prior IC, Multivessel Coronary Artery By-pass Grafting (CABG) > 4 years prior to IC or with recurrent angina following surgery, History of ischemic or hemorrhagic stroke (> 3 months prior to IC), Peripheral occlusive arterial disease (previous limb bypass surgery or percutaneous transluminal angioplasty; previous limb or foot amputation due to circulatory insufficiency, angiographic or imaging detected significant vessel stenosis of major limb arteries)
Exclusion criteria
Exclusion criteria: • 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 • Myocardial infarction or stroke within 3 months of IC • 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) at Visit 1 • Planned cardiac surgery or angioplasty within 3 months • Impaired renal function, defined as GFR<30 ml/min (MDRD formula) • Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption • Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia) • Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years • Contraindications to background therapy according to the local label • 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 • 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 • 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 • Alcohol or drug abuse within the 3 months prior to IC • Participation in another trial with an investigational drug within 30 days prior to IC • Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Time to the first occurrence of any of the following adjudicated components of the primary composite endpoint (3-point major adverse cardiovascular events (MACE)): cardiovascular (CV) death (including fatal stroke and fatal myocardial infarction (MI)), non-fatal MI (excluding silent MI), and non-fatal stroke. Percentage of patients with the event are presented. Measure:Time to the First Occurrence of Any of the Following Adjudicated Components of the Primary Composite Endpoint (3-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), and Non-fatal Stroke Timepoints:From randomisation to individual end of observation, up to 4.6 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:The composite of all events adjudicated (4-point MACE): cardiovascular death (including fatal stroke and fatal myocardial infarction), non-fatal myocardial infarction (excluding silent MI), non-fatal stroke and hospitalization for unstable angina pectoris.This is a key secondary endpoint of the trial. Percentage of patients with the event are presented. Measure:Percentage of Participants With the Composite of All Events Adjudicated (4-point MACE): CV Death (Including Fatal Stroke and Fatal MI), Non-fatal MI (Excluding Silent MI), Non-fatal Stroke and Hospitalization for Unstable Angina Pectoris Timepoints:From randomisation to individual end of observation, up to 4.6 years ; Outcome name:Silent MI; defined as presence in the ECG of: Any Q-wave in leads V2-V3 ≥0.02 seconds or QS complex in leads V2 and V3 Q-wave ≥0.03 seconds and ≥0.1 mV deep or QS complex in leads I, II, aVL, aVF, or V4-V6 in any two leads of a contiguous lead grouping (I, aVL, V6; V4-V6; II, III, and aVF) R-wave ≥0.04 seconds in V1-V2 and R/S ≥1 with a concordant positive T-wave in the absence of a conduction defect. It was also required that there had been no adjudicated and confirmed event of either acute MI, hospitalisation for unstable angina, coronary revascularisation procedures or stent thrombosis following randomisation up to and including the date of the specified ECG measurement. Percentage of patients with the event are presented. Measure:Percentage of Participants With Silent MI Timepoints:From randomisation to individual end of observation, up to 4.6 years ; Outcome name:Heart failure requiring hospitalisation (adjudicated). Percentage of patients with the event are presented. Measure:Percentage of Participants With Heart Failure Requiring Hospitalisation (Adjudicated) Timepoints:From randomisation to individual end of observation, up to 4.6 years ; Outcome name:New ons | — |
Countries
Austria, Belgium, Czech Republic, Denmark, Estonia, Greece, Hungaria, Italy, Netherlands, Peru, Portugal, Spain, United Kindgdom
Contacts
Public ContactLuis Miguel Melendez
PPD Peru S.A.C.
Outcome results
None listed