NL-OMON45372尚未招募3 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 - ITCA 650-CLP-203 - FREEDOM-4-OAD
Intarcia Therapeutics, Inc0 个研究点目标入组 21 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 21
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
- 年龄范围
- 18 至 64（—）
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
- •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.
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
- •17. Uncontrolled hypertension: sitting systolic blood pressure >=180
- •mmHg and /or sitting diastolic blood pressure >100 mmHg at Screening
- 另有 5 项未显示
研究者
相似试验
进行中（未招募）
1 期
A Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Comparators Empagliflozin and Glimepiride in Patients with Type 2 Diabetes that are on Metformin TherapyEUCTR2016-001165-88-NLIntarcia Therapeutics, Inc.930
进行中（未招募）
1 期
A Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Comparators Empagliflozin and Glimepiride in Patients with Type 2 Diabetes that are on Metformin TherapyEUCTR2016-001165-88-GBIntarcia Therapeutics, Inc.930
进行中（未招募）
1 期
A Study to Compare the Efficacy, Safety and Tolerability of ITCA 650 to Comparators Empagliflozin and Glimepiride in Patients with Type 2 Diabetes that are on Metformin TherapyType 2 diabetesMedDRA version: 19.1Level: PTClassification code 10067585Term: Type 2 diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 19.1Level: LLTClassification code 10045242Term: Type II diabetes mellitusSystem Organ Class: 10027433 - Metabolism and nutrition disordersEUCTR2016-001165-88-SEIntarcia Therapeutics, Inc.930
尚未招募
3 期
Bomedemstat vs BAT for Essential Thrombocythemiaessential thrombocythemiaJPRN-jRCT2031230658Koh Yasuhiro17
进行中（未招募）
不适用
A study to evaluate ITCA 650 compared to sitagliptin as add-on therapy for the treatment of type 2 diabetesEUCTR2012-002117-19-LVIntarcia Therapeutics, Inc.500