Saxagliptin Assessment of Vascular Outcomes Recorded in Patients withDiabetes MellitusA Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagliptin on the Incidence of Cardiovascular Death, Myocardial Infarction or Ischaemic Stroke in Patients with Type 2 Diabetes - SAVOR
- Conditions
- Type 2 diabetes mellitusMedDRA version: 12.1Level: LLTClassification code 10067585Term: Type 2 diabetes mellitus
- Registration Number
- EUCTR2009-017358-10-FR
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 12000
1. Provision of informed consent prior to any study-specific procedures
2. Age =40 years
3. Diagnosed with T2DM based on the current American Diabetes Association guidelines
4. HbA1c =6.5% (based on the last measured and documented laboratory measurement in the previous 6 months)
5. High risk for a CV event defined as having either established CV disease and/or multiple risk factors:
Established CV disease:
Ischaemic heart disease, and/or
Peripheral vascular disease (eg, intermittent claudication), and/or
Ischaemic stroke
Multiple Risk Factors
Patient must be at least 55 years old (men) and 60 years old (females) and have at least one additional risk factor (treated or non-treated) from the following:
Dyslipidemia (based on the last measured and documented laboratory measurement in the previous 6 months and defined as at least 1 of the following):
o High level of low-density lipoprotein cholesterol (LDL-C), defined as >130 mg/dL (> 3.36 mmol/L)
o Low level of high-density lipoprotein cholesterol (HDL-C), defined as <40 mg/dL (<1.04 mmol/L) for men or <50 mg/dL (<1.30 mmol/L) for women
Hypertension, as confirmed at the enrolment visit
o BP >140/90 mm/Hg or on a BP-lowering agent with BP >130/80 mm/Hg
Currently smoking, as confirmed at the enrolment visit
6. Women of childbearing potential (WOCBP) must take precautions to avoid pregnancy throughout the study and for 4 weeks after intake of the last dose. Men participating in the study should also take precautions not to father a child
while participating in the study and for 4 weeks after intake of the last dose. WOCBP must have a negative urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 72 hours prior to the start of study medication.
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilisation (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal (defined as amenorrhea =2 consecutive years).
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. Any conditions that, in the opinion of the Investigator, may render the patient unable to complete the study including non-CV disease (eg, active malignancy, cardiomyopathy, cirrhosis, or chronic lung disease) with a likely fatal outcome within 5 years
2. Current or previous (within 6 months) treatment with an incretin-based therapy such as DPP4 inhibitors and or GLP-1 mimetics
3. Acute vascular (cardiac or stroke) event <2 months prior to randomization
4. Initiation of chronic dialysis and/or renal transplant and/or a serum creatinine >6.0 mg/dL
5. Pregnant or breast-feeding patients
6. History of human immunodeficiency virus
7. Patients being treated for severe auto immune diseases such as lupus
8. Any patient currently receiving chronic (>30 consecutive days) treatment with an oral steroid
9. Patients with:
Body mass index >50 kg/m2
Last measured HbA1c =12%
Sustained BP >180/100 mm Hg
LDL-C >250 mg/dL (> 6.48 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months)
Triglycerides >1000 mg/dL (>11.3 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months)
HDL-C <25 mg/dL (<0.64 mmol/L) (based on the last measured and documented laboratory measurement in the previous 6 months)
Known liver function tests >3 times upper limit of normal (ULN), (based on the last measured and documented laboratory measurement in the previous 6 months)
10. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca and BMS or representative staff and/or staff at the study site)
11. Previous randomisation in the present study
12. Participation in another clinical study with IP and/or intervention within 30 days prior to Visit 1
13. Individuals at risk for poor protocol or medication compliance
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