EUCTR2009-017266-23-EE进行中（未招募）不适用
A Phase III, Multicenter, Randomized, Double-blind, Placebo-Controlled, Safety Study to Evaluate Cardiovascular Outcomes in Patients With Type 2 Diabetes Mellitus Treated With Dutogliptin
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 5,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Able to understand and provide written informed consent before the initiation of any study-related procedures
- •2. Male or female outpatients aged 40 to 85 years, inclusive
- •3. Diagnosis of T2DM for at least 3 months
- •4. Treatment naive or receiving stable treatment for T2DM (see also exclusion criterion #1)
- •? Treatment naive is defined as no treatment with oral hypoglycemic agents, insulin, or other diabetes medication for a minimum of 4 weeks
- •? Stable treatment for oral hypoglycemic agents is defined as the same dosage for at least 4 weeks, except for pioglitazone, for which stable dose means the same dose for at least 12 weeks
- •? Stable treatment for insulin means that the total number of units of insulin (short, intermediate, and long-acting) has not changed by more than 15% in the 4 weeks preceding Visit 1
- •5. HbA1c value of 6.5% to 10%, inclusive
- •6. Fasting Plasma Glucose (FPG) value = 270 mg/dL (15 mmol/L)
- •7. Stable weight, with no more than a 7% weight gain or loss in the last 3 months (by history)
- •8. Body mass index (BMI) of 20 to 48 kg/m2, inclusive
- •9. Having (A) a history of previously demonstrated CV disease OR (B) the presence of multiple risk factors for CV disease
- •A. History of previously demonstrated CV disease includes any of the following:
- •1) Any previous clinical CV events: myocardial infarction, unstable angina pectoris with diagnostic ischemic ST-T wave changes on electrocardiogram (ECG), or stroke but not within 2 months of Visit 1 for these clinical events),
- •2) Positive diagnostic tests: ankle-brachial index < 0.7 or clear myocardial ischemia on exercise stress testing with nuclear perfusion or echocardiographic imaging. (Patients should be enrolled only if no revascularization procedure is being planned in response to the diagnostic test result.),
- •3) Revascularization procedures: surgical or percutaneous revascularization procedures on one or more sites of coronary, carotid, or peripheral arteries, eg, coronary artery bypass grafting, angioplasty, stent placement; carotid endarterectomy; ilio-femoral or femoral-popliteal bypass grafting, renal artery angioplasty or stenting (if performed due to renal arterial atherosclerotic
- •disease only). Procedures should not have occurred within 4 weeks of Visit 1 if revascularization was performed electively and not within 2 months if revascularization was performed at the time of presentation with an acute coronary syndrome
- •B. Presence of multiple risk factors indicative of increased risk for CV disease is defined as follows:
- •1) Patient’s age = 60 years for males or = 65 years for females, AND
- •2) Patient has 3 or more of the following risk factors:
- •- Current treatment with 2 or more antihypertensive medications
- •(Antihypertensive treatment with a fixed-dose combination product will count as treatment with 2 medications; however, a combination product of 2 diuretics will only count as 1 antihypertensive [eg, hydrochlorothiazide/triamterene])
- •- eGFR = 35 to < 60 mL/min/1.73 m2 as assessed by the MDRD study equation
- •- Echocardiographic evidence of left ventricular hypertrophy
- •- Low-density lipoprotein cholesterol level = 160 mg/dL (4.1 mmol/L), whether or not the patient is receiving treatment with a dyslipidemia medication
- •- Albuminuria or persistent microalbuminuria (urine albumin-to-creatinine ratio [ACR] > 30 µg/mg) on two or more occasions including on the Visit 1 assessment
- •- Current cigarette smoking or having quit within the 3 months before screening
- •Note: If patient
排除标准
- •1. Taken a GLP-1 agonist (eg, exenatide, liraglutide), rosiglitazone, or a DPP-4 inhibitor (eg, Januvia [sitagliptin], Galvus [vildagliptin], Onglyza [saxagliptin], alogliptin) in the past 3 months
- •2. Type 1 diabetes mellitus, maturity-onset diabetes of the young, or any unusual or rare form of diabetes mellitus
- •3. Elevated blood glucose resulting from medical treatment or from a concurrent medical condition other than T2DM, eg, hyperadrenocorticalism caused by Cushing syndrome (or Cushing disease), pheochromocytoma, acromegaly, and hyperthyroidism
- •4. Skin lesions (eg, discoloration, swelling, atrophy, ulceration) or edema states that are considered medically important by the Investigator
- •5. Current diabetic foot ulcer or a foot ulcer that healed within the month before screening
- •6. History of epilepsy, not including childhood febrile seizures
- •7. History of hypoglycemic episode requiring the assistance of a second person to
- •administer glucose, glucagon, orange juice, etc, during the 6 months before screening
- •8. History of diabetic ketoacidosis ever, or hyperosmolar, hyperglycemic, nonketotic
- •syndrome during the 6 months before screening
- •9. Congestive heart failure class III or IV (according to the New York Heart Association
- •functional classification system) at screening or during the month before screening
- •10. History of or risk factors for acute pancreatitis (eg, alcohol abuse, extreme
- •hypertriglyceridemia [> 1000 mg/dL], multiple small gallstones [unless cholecystectomy subsequently performed]), or risk factors for exacerbation of chronic
- •pancreatitis
- •11. Systolic blood pressure (SBP) = 160 mm Hg or < 90 mm Hg and/or diastolic blood
- •pressure (DBP) = 90 mm Hg or < 50 mm Hg. The measurement can be repeated once
- •if the initial reading is considered by the Investigator to be inaccurate or
- •unrepresentative of the patient’s usual blood pressure, and the second value used to meet this criterion
- •12. Taken systemic glucocorticoids at a dosage > 5 mg of prednisone or equivalent daily within the 2 weeks before screening. See study reference manual for prednisone equivalence of other glucocorticoids
- •13. History of cancer, other than treated basal cell or squamous cell carcinoma of the
- •skin, unless the malignancy has been in complete remission for at least 3 years.
- •(Complete remission is defined as the disappearance of all signs of cancer in response to treatment)
- •14. History of infection with or history of serologic evidence of previous infection with
- •human immunodeficiency virus, hepatitis B, or hepatitis C virus
- •15. History of alcohol or cocaine abuse in the past 2 years or current use of other illicit drugs that, in the judgment of the PI, would negatively affect the patient’s ability to participate in the study
- •16. Total bilirubin level above the upper limit of normal (ULN), unless associated with an elevated indirect total bilirubin typical of Gilbert syndrome; aspartate
- •aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 × ULN; or alkaline
- •phosphatase > 1.5 × ULN
- •17. eGFR as assessed by the MDRD study equation < 35 mL/min/1.73 m2
- •18. Treatment with any IP or participation in any investigational study within 30 days or 5 half-lives of the IP before screening
- •19. Randomized in a previous investigational study of dutogliptin
- •20. Employee or relative of an employee of the investigational study center or of anyone associated with the conduct of the study
- •21. History of hypersensitivity reaction to dutogliptin or other DPP-4 inhibitor
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