The Effect of LY2189265 on Blood Pressure and Heart Rate, as Assessed by Ambulatory Blood Pressure Monitoring, in Patients With Type 2 Diabetes Mellitus

Eli Lilly0 个研究点目标入组 683 人开始时间: 待定最近更新: 2021年11月24日

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•Type 2 diabetes taking 1 or more oral diabetes medications and have taken these medications for at least 1 month prior to screening
•-HbA1c value greater than or equal to 7% and less than or equal to 9.5% at screening
•-Mean blood pressure > 90/60 mmHg and < 140/90 mmHg at screening
•-If treated for hypertension, are taking 3 or less medications and have been taking these medications for at least 1 month prior to screening
•-Stable weight for 3 months prior to screening
•-BMI (body mass index) greater than or equal to 23 kg/m2
•-Willing to wear an ambulatory blood pressure monitoring device for at least 24 hours on multiple occasions
•-Women of childbearing potential must test negative for pregnancy and be willing to use a reliable method of birth control
•-Male patients must use a reliable method of birth control

•-Myocardial infarction, stroke, or hospitalization for heart failure within 3 months prior to screening, or heart failure Class III or IV at screening
•-Ongoing or history of frequent intermittent tachyarrhythmia
•-Resting heart rate < 60 bpm or > 100 bpm at screening
•-Work rotating shifts or work during the hours of 2200 to 0700
•-Chronic insulin therapy
•-Use of a GLP-1 receptor agonists within 3 months prior to screening, or a dipeptidylpeptidase-IV (DPP-IV) inhibitor within 2 weeks prior to screening
•-Nondominant arm circumference > 42 cm
•-Use of drugs to promote weight loss
•-Chronic use of systemic steroids
•-Gastric emptying abnormality or bariatric surgery
•-Hepatitis, other liver disease, or alanine transaminase (ALT) > 3 times the upper limit of normal
•-Acute or chronic pancreatitis
•-Severe renal impairment
•-Active autoimmune disease or uncontrolled endocrine abnormality
•-Self or family history of thyroid cancer, medullary C-cell hyperplasia, or type 2A or 2B multiple endocrine neoplasia
•-Calcitonin value greater than or equal to 20 pg/ml at screening
•-Transplanted organ except corneal transplants
•-Active or untreated cancer or in remission < 5 years, except skin, in situ cervical, or prostate cancer
•-Sickle-cell disease, hemolytic anemia, or another hematological condition that may interfere with HbA1c testing

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