EUCTR2016-001165-88-SE进行中（未招募）1 期
A Phase 3b, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients with Type 2 Diabetes - FREEDOM-4-OAD
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
- 930
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. Understanding of the study procedures and conditions of the protocol and agreement to participate in the study by providing a signed and dated informed consent prior to any study-specific procedures.
- •2. Male or female patients 18 to 80 years old, inclusive.
- •3. Diagnosis of T2D = 3 months prior to the Screening Visit.
- •4. Body mass index (BMI) between = 25 to = 45 kg/m2 at the Screening Visit.
- •5. Stable body weight (not varying by >10%) = 3 months prior to the Screening Visit.
- •6. Glycosylated hemoglobin A1c (HbA1c) =7.5 and =10.5%. One re-test of this parameter is allowed prior to Visit 2.
- •7. Calcitonin <50 ng/L (50 pg/mL) at the Screening Visit.
- •8. On a stable (= 3 months prior to the Screening Visit) treatment regimen of metformin monotherapy of =1500 mg/day.
- •9. Agreement to maintain the same dose of background metformin from the Screening Visit to the end of the study (unless a change is clinically indicated).
- •10. Women may be enrolled if all of the following criteria (in addition to other criteria) are met: they are not pregnant; they are not breast feeding; and they do not plan on becoming pregnant during the study.
- •11. Women of childbearing potential (WOCBP) must have a negative pregnancy test at the Screening Visit. Women are considered to be of childbearing potential unless they meet one of the following criteria as documented by the Investigator:
- •They have had a hysterectomy or tubal ligation prior to signing the informed consent form (ICF); or
- •They are post-menopausal, defined for women = 50 years old as = 2 years since their last menstrual period and for women >50 years old as = 1 year since their last menstrual period.
- •12. WOCBP must agree to use an adequate method of contraception during the study and for 1 additional menstrual cycle after the Follow-up visit. Women practicing abstinence or whose partner(s) is (are) sterile should be considered to be of childbearing potential. Adequate methods of contraception for WOCBP include: oral, implanted or injectable contraceptive hormones; mechanical products (intrauterine device); or barrier methods (diaphragm, condoms, cervical cap) with spermicide. The patient’s understanding of this requirement must be documented by the Investigator.
- •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 694
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 236
排除标准
- •Diabetes Therapy or History
- •1. History of type 1 diabetes, diabetes that is the result of pancreatic injury, or secondary forms of diabetes, (eg, Cushing’s syndrome) and/or acute metabolic complications such as diabetic ketoacidosis or hyperosmolar state (coma)
- •2. Participation in a clinical study involving ITCA 650
- •3. Treatment with any GLP-1 receptor agonist within 6 months prior to Screening or at any time in the past if therapy was discontinued due to gastrointestinal intolerance. This includes treatment during participation in a clinical study
- •4. Treatment with any of the following antidiabetic agents within 3 months prior to Screening: sodium-glucose cotransporter-2 inhibitors, sulfonylureas, dipeptidyl peptidase-4 inhibitors, alpha glucosidase inhibitors, meglitinides, thiazolidinediones, bile acid sequestrants (eg, colesevelam), dopamine receptor agonists (eg, bromocriptine), amylin analogues (eg, pramlitide), or insulin. NOTE: History of short term (<14 days) use of insulin is allowed as long as the last dose was administered more than 2 weeks prior to the Screening
- •5. FPG >270 mg/dL (15 mmol/L). One re-test of this parameter is allowed prior to randomization
- •6. Significant symptomatic hyperglycemia: polyuria, polydipsia, unexplained weight loss
- •7. Any condition, clinically significant laboratory abnormality or therapy, which might pose a risk to the patient, or interfere with the conduct of the study or interpretation of the safety and efficacy data
- •8. Alcohol or substance abuse within 1 year prior to Screening
- •9. Treatment with an investigational drug within 30 days prior to screening or 5 half-lives (whichever is longer); participation in a clinical study involving an investigational product or non-approved use of a drug or device or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
- •10. History of hypersensitivity to exenatide, empagliflozin, or glimepiride or to one of its excipients
- •11. Contraindications or warnings according to the specific labels for metformin, empagliflozin, or glimepiride therapy
- •12. History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2
- •13. Presence of a thyroid nodule, detected on a physical examination that has not been fully evaluated
- •14. Thyroid-stimulating hormone outside of normal limits at Screening. One re- test of this parameter is allowed prior to inclusion
- •15. Thyroid hormone therapy that has not been stable for =6 weeks prior to Screening
- •Cardiovascular
- •16. History or evidence, within the last 6 months prior to the Screening Visit, of any of the following: myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, cerebrovascular accident or stroke
- •17. Uncontrolled hypertension: sitting systolic blood pressure =180 mmHg and /or sitting diastolic blood pressure >100 mmHg at Screening (may be repeated after 15 minutes and exclusion will be based on the last measurement)
- •18. Congestive heart failure (Grade III and IV acc. to NYHA classification)
- •19. Estimated glomerular filtration rate (eGFR) <60 mL/min/1.73 m2 at the Screening
- •Hepatic/Pancreatic/Gastrointestinal
- •20. History or evidence of acute or chronic pancreatitis
- •21. History of weight loss surgery
- •22. History of current infectious liver disease including hepatitis B or hepatitis C virus. Patients wh
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