EUCTR2009-016178-33-FRActive, 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.
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Boehringer Ingelheim France
- Enrollment
- 4,000
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:
- •History of myocardial infarction (> 2 months prior to IC)
- •Unstable angina (> 2 months prior IC)
- •Multivessel Percutaneous Coronary Intervention (PCI) > 2 months 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 (> 2 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)
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
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)
- •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. Participation in another trial with an investigational drug within 30 days prior to IC
- •14. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Investigators
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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.The study will be performed in patients with type 2 diabetes mellitus and high cardiovascular risk who have insufficient glycaemic control despite diet and exercise and are either treatment naïve or receiving any antidiabetic background therapy.Drug-naïve is defined as absence of any antidiabetic therapy for 12 weeks prior to randomisation.MedDRA version: 18.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2009-016178-33-PTnilfarma, Lda.7,000