CTRI/2018/07/015083Other3 期
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 - NA
Sanofi Synthelabo India Private Limited0 个研究点目标入组 98 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- Other
- 发起方
- 入组人数
- 98
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
- •1 Participants with T2DM and HbA1c greater than 7 percent
- •2 Participants who meet at least one of the 8 CVD criteria OR male participants who are greater or equal to 50 years of age or female participants who are greater or equal to 55 years of age and have an eGFR greater or equal to 25 and less than 60 mL per min and have at least one of the 6 CV risk factors
- •3 Presence of Coronary Artery Disease
- •4 Presence of Cerebrovascular Disease
- •5 Presence of Peripheral Arterial Disease
- •6 coronary artery bypass graft
- •7 Body mass index greater or qual to 35 kg per m2 at Screening
- •8 Male or Female
- •a A male participant must agree to use contraception 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 A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies.Not a WOCBP
- •A WOCBP who agrees to follow the contraceptive guidance as per final protocol during the intervention period and for at least 5 weeks after the last dose of study intervention.
- •9 I 05.Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form ICF and in this protocol.
排除标准
- •1 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
- •2 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
- •3 Personal or family history of medullary thyroid cancer MTC or genetic conditions that predisposes to MTC eg, multiple endocrine neoplasia syndromes
- •4 Estimated glomerular filtration rate less than 25 mL per min per 1.73 m² by the 4 variable Modification of Diet in Renal Disease MDRD equation at Screening, based on central laboratory
- •5 Systolic BP greater than 180 mmHg and or DBP greater than 100 mmHg at randomization
- •6 Hospitalization for hypertensive emergency within 3 months prior to randomization
- •7 Planned coronary revascularization procedures, electrophysiologic device implantation, cardiac mechanical support implantation or other cardiac surgery
- •8 History of solid organ transplant
- •9 Hypersensitivity to any of the study treatments or any components thereof
- •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 or proliferative diabetic retinopathy [PDR]/Diabetic Macular Edema
- •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
- •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 or IV, respiratory, hepatic, neurological, psychiatric, active malignant tumor or other major systemic disease
- •13 History of drug or alcohol abuse within 6 months prior to the time of screening
- •Prior/concomitant therapy
- •14 Treated with any GLP 1 RA product eg, exenatide, liraglutide, lixisenatide, albiglutide, dulaglutide, semaglutide within 3 months prior to screening
- •15 Use of any DPP4 inhibitor within 12 weeks prior to screening
- •16 Diabetic treatment has not been stable in the 12 weeks prior to screening, in the opinion of the investigator
- •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 or concurrent clinical study experience
- •18 Exposure to any investigational drugs in the last 4 weeks or 5 half-lives, whichever is longer, prior to screening
- •19 Current enrollment in any other clinical study involving an investigational study treatment
- •20 Participation in any previous efpeglenatide or HM11260C clinical trial within 3 months prior to screening
- •21 Participant is the Investigator or any Subinvestigator, research assistant, pharmacist, study coordinator, other staff or relative thereo
研究者
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