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
- 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: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2009-016178-33-NL
- Lead Sponsor
- Boehringer Ingelheim B.V.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 11531
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 = 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 (> 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)
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
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. Myocardial infarction or stroke within 3 months of IC
3. 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
4. Planned cardiac surgery or angioplasty within 3 months
5. Impaired renal function, defined as GFR<30 ml/min (MDRD formula)
6. Bariatric surgery within the past two years and other gastrointestinal surgeries that induce chronic malabsorption
7. Blood dyscrasias or any disorders causing haemolysis or unstable Red Blood Cell (e.g. malaria, babesiosis, haemolytic anemia)
8. Medical history of cancer (except for basal cell carcinoma) and/or treatment for cancer within the last 5 years
9. Contraindications to background therapy according to the local label
10. 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
11. 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
12. 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
13. Alcohol or drug abuse within the 3 months prior to IC
14. Participation in another trial with an investigational drug within 30 days prior to IC
15. Any other clinical condition that would jeopardize patients safety while participating in this clinical trial
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method