Trial to Evaluate Cardiovascular Outcomes with Sitaglipti
- Conditions
- Health Condition 1: null- Type 2 Diabetes Mellitus with pre existing documented vascular disease in the coronary, cerebral or peripheral arteries.Health Condition 2: E119- Type 2 diabetes mellitus without complications
- Registration Number
- CTRI/2009/091/000563
- Lead Sponsor
- Duke Clinical Research Institute
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 14000
Patients must meet the following criteria to participate in the study:
a) Patient has T2DM and has not previously required insulin other than for a short term, reversible illness (less than three consecutive months of insulin use), or during pregnancy.
b) Patient is able to see a usual care provider at least twice a year
c) Patient is receiving metformin, pioglitazone, or a sulfonylurea as monotherapy or any dual combination of metformin, pioglitazone, or a sulfonylurea continuously for at least 3 months without dose alterations, and has an HbA1c of ≥ 6.5% and ≤ 8.0% (HbA1c must be documented within 3 months prior to study enrollment).
Patients whose HbA1c is 8.0% may, at the discretion of the investigator, have their oral AHA therapy adjusted and be re-screened for randomization eligibility (HbA1c of ≥ 6.5% and ≤ 8.0%) following a 3-month period on a stable AHA dose.
d) Patient is ≥ 50 years of age with preexisting vascular disease, defined as having any
one of the following:
i) History of a major clinical manifestation of coronary artery disease (i.e., myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis ≥ 50% in a major epicardial artery or branch vessel);
ii) Ischemic cerebrovascular disease, including:
?History of ischemic stroke. Strokes not known to be hemorrhagic will be allowed as part of this criterion;
?History of carotid arterial disease as documented by ≥ 50 % stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit.
? Atherosclerotic peripheral arterial disease, as documented by objective evidence such as amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or toe brachial pressure index less than 0.9 or history of surgical or percutaneous revascularization procedure.
e) Female patients agree to use an effective method of contraception or must not otherwise be at risk of becoming pregnant.
f) Patient understands the study procedures, alternative treatments available, and the risks involved with the study, and voluntarily agrees to participate by providing written informed consent.
g) Patient agrees to provide permission to obtain all medical records necessary for complete data ascertainment during the follow-up period.
Patient has a history of type 1 diabetes mellitus, a history of ketoacidosis, or is currently taking insulin.
b) Patient has taken an approved or investigational DPP-4 inhibitor agent (e.g., sitagliptin, alogliptin, saxagliptin, or vildagliptin), GLP-1 analogues (e.g., exenatide, exenatide LAR, or liraglutide), or a thiazolidinedione other than pioglitazone within the past three months.
c) Patient has cirrhosis of the liver, as assessed by medical history.
d) Patient is enrolled in another experimental protocol which involves the use of an investigational drug or device, or an intervention that would interfere with the conduct of the trial.
e) Patient has a planned or anticipated revascularization procedure.
f) Pregnancy or planned pregnancy during the trial period.
g) Patient has medical history that indicates a life expectancy of < 2 years or might limit the individual?s ability to take trial treatments for the duration of the study.
h) Patient has a history or current evidence of any condition, therapy, lab abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose a risk to the patient, make participation not in the patient?s best interest, confound the results of the study (e.g., if patient cannot comply with requirements of
the study), or interfere with the patient?s participation for the full duration of the study.
i) Patient has an estimated GFR (calculated based on serum creatinine via the MDRD formula [10]) of < 30 mL/min/1.73 m2.
j) Patient has a known allergy or intolerance to sitagliptin.
k) Patient has previously been enrolled in this trial.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to first confirmed CV event in the primary composite CV endpointTimepoint: Defined as the time from randomization to first confirmed event in the primary composite CV endpoint (CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization).
- Secondary Outcome Measures
Name Time Method