PER-017-18招募中未知
A Randomized, Double-blind, Placebo-controlled,Parallel-group, Multicenter Study to Evaluate the Effectof Efpeglenatide on Cardiovascular Outcomes in Type 2Diabetes Patients at High Cardiovascular Risk
Sanofi Aventis Recherche & Development,0 个研究点目标入组 81 人开始时间: 2018年10月23日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 81
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
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •I 01. Participant must be ≥18 years of age at the time of signing the informed consent.
- •Type of participant and disease characteristics
- •I 02. Participants with T2DM and HbA1c >7%
- •I 03. Participants who meet at least one of the 8 CVD criteria in Table 3 (Review Protocol Section 5.1)
- •male participants who are ≥50 years of age or female participants who are ≥55 years of
- •age and have an eGFR ≥25 and <60 mL/min and have at least one of the 6 CV risk factors
- •listed in Table 4 (Review Protocol Section 5.1)
- •I 04. Male or Female
- •a) Male participants: A male participant must agree to use contraception as detailed in
- •Appendix 4 (Section 10.4) of this protocol during the intervention period and for at
- •least 5 weeks after the last dose of study intervention and refrain from donating sperm
- •during this period.
- •b) Female participants: A female participant is eligible to participate if she is not pregnant
- •(see Appendix 4 [Section 10.4]) of this protocol, not breastfeeding, and at least one of the following
- •conditions applies:
- •- Not a WOCBP as defined in Appendix 4 (Section 10.4) of this protocol
- •- A WOCBP who agrees to follow the contraceptive guidance in Appendix 4
- •(Section 10.4) of this protocol during the intervention period and for at least 5 weeks after the last dose
- •of study intervention.
- •Informed Consent
- •I 05. Capable of giving signed informed consent as described in Appendix 1 (Section 10.1.2) of this protocol
- •which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
排除标准
- •Medical conditions
- •E 01. Clinically relevant history of GI disease associated with prolonged nausea and vomiting,
- •including (but not limited to) gastroparesis, unstable and uncontrolled gastroesophageal
- •reflux disease within 6 months prior to screening
- •E 02. History of pancreatitis (unless pancreatitis was related to gallstone and cholecystectomy
- •has been performed) and pancreatitis during previous treatment with incretin therapies,
- •chronic pancreatitis, and pancreatectomy
- •E 03. Personal or family history of medullary thyroid cancer (MTC) or genetic conditions that
- •predisposes to MTC (eg, multiple endocrine neoplasia syndromes)
- •E 04. Estimated glomerular filtration rate <25 mL/min/1.73 m² by the 4 variable Modification of
- •Diet in Renal Disease (MDRD) equation (at Screening, based on central laboratory)
- •E 05. Systolic BP >180 mmHg and/or DBP >100 mmHg at randomization
- •E 06. Hospitalization for hypertensive emergency within 3 months prior to randomization
- •E 07. Planned coronary revascularization procedures, electrophysiologic device implantation,
- •cardiac mechanical support implantation or other cardiac surgery
- •E 08. History of solid organ transplant
- •E 09. Hypersensitivity to any of the study treatments or any components thereof
- •E 10. No documented ophthalmologic exam with fundoscopy within 6 months prior to screening
- •(or within 3 months in patients with severe non proliferative diabetic retinopathy [NPDR]/
- •proliferative diabetic retinopathy [PDR]/Diabetic Macular Edema [DME])
- •E 11. Retinopathy or maculopathy with one of the following treatments, either recent (3 months prior to randomization) or planned during the study: intravitreal injections or laser or vitrectomy surgery
- •E 12. Patients with short life expectancy making implementation of the protocol or interpretation
- •of the study results difficult in the opinion of the investigator including severe anemia,
- •congestive heart failure (New York Heart Association [NYHA] III/IV), respiratory,
- •hepatic, neurological, psychiatric, active malignant tumor or other major systemic disease
- •E 13. History of drug or alcohol abuse within 6 months prior to the time of screening
- •Prior/concomitant therapy
- •E 14. Treated with any GLP-1 RA product (eg, exenatide, liraglutide, lixisenatide, albiglutide,
- •dulaglutide, semaglutide) within 3 months prior to screening
- •E 15. Use of any DPP4 inhibitor within 12 weeks prior to screening
- •E 16. Diabetic treatment has not been stable in the 12 weeks prior to screening, in the opinion of
- •the investigator
- •E 17. Use of systemic glucocorticoids (excluding topical application or inhaled forms) for more
- •than 10 consecutive days within 3 months prior to Screening Visit or for more than
- •10 consecutive days between Screening and randomization
- •Prior/concurrent clinical study experience
- •E 18. Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is
- •longer, prior to screening
- •E 19. Current enrollment in any other clinical study involving an investigational study treatment
- •E 20. Participation in any previous efpeglenatide/HM11260C clinical trial within 3 months prior
- •to screening
- •E 21. Participant is the Investigator or any Subinvestigator, research assistant, pharmacist, study
- •coordinator, other staff or relative thereof directly involved in the conduct of the protocol
研究者
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