EUCTR2014-003503-29-SK进行中（未招募）1 期
A 28-week, Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Study with a 24-week Extension Phase Followed by a 52-week Extension Phase to Evaluate the Efficacy and Safety of Simultaneous Administration of Exenatide Once Weekly 2 mg and Dapagliflozin Once Daily 10 mg Compared to Exenatide Once Weekly 2 mg Alone and Dapagliflozin Once Daily 10 mg Alone in Patients with Type 2 Diabetes who have Inadequate Glycemic Control on Metformin
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 660
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) Is at least 18 years old at Screening; the upper age limit should be based on local metformin label restrictions.
- •2) Has a diagnosis of T2DM.
- •3) Has HbA1c of 8.0% to 12.0%, inclusive, at Visit 1 and Visit 2.
- •4) Treated with a stable dose of metformin =1500 mg/day for at least 2 months prior to Screening.
- •5) Is male, or is female and meets all the following criteria:
- •?-Not breastfeeding.
- •?-Negative pregnancy test result (human chorionic gonadotropin, beta subunit [ßhCG]) at Visit 1 (Screening) (not applicable to hysterectomized females).
- •?-If of childbearing potential (including perimenopausal women who have had a menstrual period within 1 year), must practice and be willing to continue to practice appropriate birth control (defined as a method which results in a low failure rate, ie, less than 1% per year, when used consistently and correctly, such as implants, injectables, hormonal contraceptives [pills, vaginal rings, or patches], some intrauterine contraceptive devices [levonorgestrel-releasing or copper-T], tubal ligation or occlusion, or a vasectomized partner) during the entire duration of the study. As applicable, all methods must be in effect prior to receiving the first dose of study medication.
- •?-Must practice appropriate birth control as stated above for 10 weeks after the last dose of study medication.
- •6) Patients who are receiving the following medications must be on a stable treatment regimen for a minimum of 2 months prior to Visit 1 (Screening):
- •?-Antihypertensive agents
- •?-Thyroid replacement therapy
- •?-Antidepressant agents.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 594
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 66
排除标准
- •1.FPG =280 mg/dL (15.6 mmol/L).
- •2.Serum calcitonin concentration =40 pg/mL (=40 ng/L) at Visit 1 (Screening).
- •3.Clinically significant abnormal free T4 values or patients needing initiation or adjustment of thyroid treatment according to the investigator. Abnormal thyroid stimulating hormone (TSH) value at Screening will be further evaluated by free T4. Patients with clinically significant abnormal free T4 values will be excluded.
- •4.Known active proliferative retinopathy.
- •5.History of, or currently have, acute or chronic pancreatitis, or have triglyceride concentrations =500 mg/dL (=5.65 mmol/L) at Visit 1 (Screening).
- •6.History or presence of inflammatory bowel disease or other severe GI diseases, particularly those which may impact gastric emptying, such as gastroparesis or pyloric stenosis.
- •7.History of gastric bypass surgery or gastric banding surgery, or either procedure is planned during the time period of the study. Current use of gastric balloons is also excluded.
- •8.Significant hepatic disease, including, but not limited to, acute hepatitis, chronic active hepatitis, or severe hepatic insufficiency, including patients with alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) >3x upper limit of normal (ULN) and/or total bilirubin (TB) >2 mg/dL (>34.2 µmol/L) (patients with TB >2 mg/dL [>34.2 µmol/L] and documented Gilbert’s syndrome will be allowed to participate).
- •9.Known history of hepatotoxicity with any medication.
- •10.Known history of severe hepatobiliary disease.
- •11.Positive serological test for hepatitis B or hepatitis C.
- •12.Clinically significant cardiovascular disease or procedure within 3 months of Visit 1, including but not limited to myocardial infarction, clinically significant arrhythmia, unstable angina, coronary artery bypass surgery, or angioplasty; or are expected to require coronary artery bypass surgery or angioplasty during the course of the study.
- •13.Presence or history of severe congestive heart failure (New York Heart Association Class IV [CCNYHA 1994]).
- •14.Severe uncontrolled hypertension defined as systolic blood pressure =180 mmHg and/or diastolic blood pressure =110 mmHg.
- •15.Creatinine clearance <60 mL/min (1 mL/s) (calculated by Cockcroft-Gault formula) or a measured serum creatinine value of =1.5 mg/dL (133 µmol/L) for male patients and =1.4 mg/dL (124 µmol/L) for female patients.
- •16.Congenital renal glucosuria.
- •17.History of unstable or rapidly progressing renal disease.
- •18.History of unexplained microscopic or gross hematuria, or microscopic hematuria at Visit 1, confirmed by a follow-up sample at next scheduled visit, where according to the investigator a satisfactory evaluation of hematuria has not been conducted based on guidance in Section 6.3.9.
- •19.Known or suspected human immunodeficiency virus (HIV) infection.
- •20.Presence or history of medullary thyroid carcinoma or multiple endocrine neoplasia type 2 (MEN 2) OR a family history of medullary thyroid carcinoma or MEN 2.
- •21.Malignancy (with the exception of basal and squamous cell carcinoma of the skin) within 5 years of Visit 1 (Screening).
- •22.Hemoglobinopathy, hemolytic anemia, or chronic anemia (hemoglobin concentration <11.5 g/dL [115 g/L] for males, <10.5 g/dL [105 g/L] for females) or any other condition known to interfere with the HbA1c methodology.
- •23.Has donated blood or had a significant blood loss within 2 months of first dose of study medication or is planning to don
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