STUDY TO ASSESS CARDIOVASCULAR OUTCOMES FOLLOWING TREATMENT WITH ERTUGLIFLOZIN IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS AND ESTABLISHED VASCULAR DISEASE
- Conditions
- Type 2 Diabetes MellitusMedDRA version: 20.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2013-002518-11-SK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 8000
1. Subjects = 40 years of age at the time of the initial Screening visit
(V1) with a diagnosis of T2DM in accordance with American Diabetes
Association (ADA) guidelines.
2. HbA1c at the Screening visit (V1) of 7.0 10.5% (53 91 mmol/mol) on
stable allowable AHA(s) or on no background AHA for at least 8 weeks
prior to the Screening visit (V1).
3. Body Mass Index (BMI) =18.0 kg/m2.
4. Subjects must have evidence or a history of atherosclerosis involving
the coronary, cerebral or peripheral vascular systems as follows (must
have at least one of the following a-d):
a. Coronary artery disease as indicated by a history of presumed
spontaneous myocardial infarction (hospitalized with final diagnosis of
myocardial infarction, excluding peri-procedural or definite secondary
myocardial infarction [eg, due to profound anemia or hypertensive
emergency, troponin increase in sepsis] in which the most recent event
occurred at least 3 months (90 days) prior to the Screening visit (V1);
OR
b. Coronary artery disease as indicated by a history of coronary
revascularization through either a Percutaneous Coronary Intervention
(PCI) at least 3 months (90 days) prior to the Screening visit (V1) or
Coronary Artery Bypass Graft (CABG) at least 3 months (90 days) prior
to the Screening visit (V1); OR
c. Ischemic (presumed thrombotic) cerebrovascular disease as indicated
by a history of ischemic stroke (hospitalized with a final diagnosis of non
hemorrhagic stroke [includes completion of a standard evaluation for
stroke in an acute care facility or stroke clinic without hospital
admission] with the most recent event occurring at least 3 months (90
days) prior to the Screening visit (V1) or a history of carotid
revascularization at least 3 months (90 days) prior to the Screening visit
(V1); OR
d. Peripheral arterial disease as indicated by:
1. Angiographically documented peripheral vascular disease; or
2. Resting ankle/brachial index (ABI) of <0.85 (measured by a certified
vascular laboratory) plus symptoms of claudication; or
3. Amputation, peripheral bypass, or peripheral angioplasty of the
extremities secondary to ischemia occurring at least 3 months (90 days)
prior to the Screening visit (V1).
5. There is adequate documentation of the objective evidence that the
subject has established vascular disease such as investigational site's
medical records, copies of such records from other institutions, or a
letter from a referring physician that specifically states the diagnosis
and date of the most recent occurrence of the qualifying event(s) or procedure(s).
6. Subject meets one of the following criteria (a, b or c):
a. Is a male;
b. Is a female not of reproductive potential defined as one who (See
Section 4.4.4.1 and Section 4.4.4.2 for refe
1. Subjects who had been previously randomized into this trial.
2. Subjects experiencing a cardiovascular event (eg, myocardial
infarction or stroke) or undergoing coronary angioplasty or peripheral
intervention procedure between the Screening visit (V1) and
randomization.
3. Subjects undergoing any cardiovascular surgery (eg, valvular surgery)
within 3 months (90 days) of the Screening visit (V1).
4. Subjects with any planned coronary revascularization or peripheral
intervention procedure or other cardiovascular surgery.
5. Subjects with New York Heart Association (NYHA) Class IV heart
failure at the Screening visit (V1).
6. Mean value for triplicate screening sitting systolic blood pressure
>160 mm Hg and/or diastolic blood pressure >90 mm Hg after at least a
5 minute seated rest at the Screening visit (V1), confirmed via 1 repeat triplicate set at the Screening visit (V1) if deemed necessary. For
subjects with a mean triplicate value of sitting systolic blood pressure
>160 mm Hg and/or diastolic blood pressure >90 mm Hg after at least a
5 minute seated rest at the Screening visit (V1) the investigator or the
treating physician is allowed to adjust background blood pressure
medication(s) to lower blood pressure values in order for the subject to
be re-assessed for enrollment eligibility.
7. Subject has a clinically significant ECG abnormality at Screening visit
(V1) that requires further diagnostic evaluation or intervention.
8. History of type 1 diabetes mellitus or a history of ketoacidosis.
9. History of other specific types of diabetes (eg, genetic syndromes,
secondary pancreatic diabetes, diabetes due to endocrinopathies, drug-
or chemical induced, and post organ transplant).
10. Subject has active, obstructive uropathy or indwelling urinary
catheter.
11. Subject has a history of malignancy =5 years prior to signing
informed consent, except for adequately treated basal cell or squamous
cell skin cancer or in situ cervical cancer.
Note (1) A subject with a history of malignancy <=5 years prior to
signing informed consent should have no evidence of residual or
recurrent disease.
Note (2) A subject with any history of melanoma, leukemia, lymphoma,
or renal cell carcinoma is excluded.
12. Subject routinely consumes >2 alcoholic drinks per day or >14
alcoholic drinks per week, or engages in binge drinking.
Note (1): One alcoholic drink is defined as 5 oz (150 mL) of wine, or 12
oz (350 mL) of beer, or 1.5 oz (50 mL) of 80 proof liquor.
Note (2): Binge drinking is defined as a pattern of 5 or more alcoholic
drinks (male), or 4 or more alcoholic drinks (female) in about 2 hours.
13. Any clinically significant malabsorption condition.
14. Subjects with a known hypersensitivity or intolerance to any SGLT2
inhibitor.
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