CTRI/2009/091/000563已完成3 期
A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Sitagliptin in Patients with Type 2 Diabetes Mellitus and Inadequate Glycemic Control:Protocol Number 082-01
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 14,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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.
排除标准
- •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.
研究者
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