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 - CASCADE-8

Active, not recruiting

• Conditions: The study will be performed in patients with type 2 diabetes mellitus and high cardiovascular risk who have insufficient glycaemic control; MedDRA version: 9.1Level: LLTClassification code 10045242

• Registration Number: EUCTR2009-016178-33-IT
• Lead Sponsor: BOEHRINGER ING.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-15
• Last Update Posted: 22 December 2015

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 8000

Inclusion Criteria

1.Diagnosis of type 2 diabetes mellitus prior to informed consent 2.Male and female patients on diet and exercise regimen who are drug-naive 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 dose should not be changed within the 12 weeks prior to randomisation by more than 5% 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 <=8.0% At Visit 1 (screening) for drug-na?ve patients. 4.Age >=18 years 5.BMI <=45 kg/m**2 (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 imaging detected (for example: ultrasound, MRI) significant vessel stenosis (>50% 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 (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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified