ChiCTR2400085559 版本V1.0 版本创建时间2024/06/12 14:35:26 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2400085559 

最近更新日期：

Date of Last Refreshed on：

 2024-06-12 14:35:16 

注册时间：

Date of Registration：

 2024-06-12 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

UBT251的安全性、耐受性、药代动力学、药效动力学的Ⅰ期临床试验

Public title：

Phase I clinical trial of safety, tolerability, pharmacokinetics and pharmacokinetics of UBT251

注册题目简写：

English Acronym：

研究课题的正式科学名称：

评估成人2型糖尿病患者多次皮下注射UBT251的安全性、耐受性、药代动力学、药效动力学的Ⅰ期临床试验

Scientific title：

Phase I clinical trial to evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multiple subcutaneous injections of UBT251 in adults with type 2 diabetes mellitus

研究课题代号(代码)：

Study subject ID：

在二级注册机构或其它机构的注册号：

The registration number of the Partner Registry or other register：

申请注册联系人：

阳喜定 

研究负责人：

方平飞;周智广 

Applicant：

XidingYang 

Study leader：

Fang pingfei; Zhou Zhiguang 

申请注册联系人电话：

Applicant telephone：

 +86 731 85295291

研究负责人电话：

Study leader's
telephone：

+86 731 85292072

申请注册联系人传真 ：

Applicant Fax：

研究负责人传真：

Study leader's fax：

申请注册联系人电子邮件：

Applicant E-mail：

 524296188@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 fangpingfei@163.com

申请单位网址(自愿提供)：

Applicant website(voluntary supply)：

研究负责人网址(自愿提供)：

Study leader's website(voluntary supply)：

申请注册联系人通讯地址：

湖南省长沙市人民中路139号

研究负责人通讯地址：

湖南省长沙市芙蓉区人民中路139号

Applicant address：

139 Renmin Zhong Lu, Changsha City, Hunan Province, China

Study leader's address：

No 139 Renmin Road Furong district

申请注册联系人邮政编码：

Applicant postcode：

研究负责人邮政编码：

Study leader's postcode：

申请人所在单位：

中南大学湘雅二医院

Applicant's institution：

The Second Xiangya Hospital of Central South University

研究负责人所在单位：

中南大学湘雅二医院

Affiliation of the Leader：

Second Xiangya Hospital of CSU

是否获伦理委员会批准：

是

Approved by ethic committee：

Yes

伦理委员会批件文号：

Approved No. of ethic committee：

 （2023）伦审【药】第（283）号

伦理委员会批件附件：

Approved file of Ethical Committee：

 查看附件View

批准本研究的伦理委员会名称：

中南大学湘雅二医院医学伦理委员会

Name of the ethic committee：

Medical Ethics Committee of the Second Xiangya Hospital of Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-08-22 00:00:00

伦理委员会联系人：

段艳

Contact Name of the ethic committee：

Duan Yan

伦理委员会联系地址：

湖南省长沙市芙蓉区人民中路139号

Contact Address of the ethic committee：

No 139 Renmin Road Furong district

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 85292476

伦理委员会联系人邮箱：

Contact email of the ethic committee：

 xy2gcpduan@163.com

研究实施负责（组长）单位：

中南大学湘雅二医院

Primary sponsor：

Second Xiangya Hospital of CSU

研究实施负责（组长）单位地址：

湖南省长沙市芙蓉区人民中路139号

Primary sponsor's address：

No 139 Renmin Road Furong district

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南

市(区县)：

Country：

China

Province：

Hunan

City：

单位(医院)：

中南大学湘雅二医院

具体地址：

湖南省长沙市芙蓉区人民中路139号

Institution
hospital：

Second Xiangya Hospital of CSU

Address：

No 139 Renmin Road Furong district

经费或物资来源：

联邦生物科技（珠海横琴）有限公司

Source(s) of funding：

Federal Biotechnology (Zhuhai Hengqin) Co., LTD

研究疾病：

2型糖尿病  

Target disease：

Type 2 diabetes

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

 I期临床试验 

Study phase：

1

研究设计：

随机平行对照 

Study design：

Parallel 

研究目的：

主要目的： 评价2型糖尿病患者多次皮下注射UBT251的安全性和耐受性（包含局部耐受性）。 次要目的： 1) 评价2型糖尿病患者多次皮下注射UBT251注射液后的PK/PD特征； 2) 评价2型糖尿病患者多次皮下注射UBT251注射液后的降糖效果； 3) 评价2型糖尿病患者多次皮下注射UBT251注射液后的免疫原性。 探索性目的： 1）探索2型糖尿病患者多次皮下注射UBT251注射液对QT/QTc间期的影响； 2）探索2型糖尿病患者多次皮下注射UBT251注射液的其它疗效。  

Objectives of Study：

Main purpose: To evaluate the safety and tolerability (including local tolerability) of multiple subcutaneous injections of UBT251 in patients with type 2 diabetes. Secondary purpose: 1) To evaluate the PK/PD characteristics of type 2 diabetes patients after multiple subcutaneous injections of UBT251 injection; 2) To evaluate the hypoglycemic effect of multiple subcutaneous injections of UBT251 in patients with type 2 diabetes; 3) To evaluate the immunogenicity of type 2 diabetes patients after multiple subcutaneous injections of UBT251 injection. Exploratory purpose: 1) To explore the effect of multiple subcutaneous UBT251 injection on QT/QTc interval in patients with type 2 diabetes mellitus; 2) To explore other therapeutic effects of multiple subcutaneous injection of UBT251 in patients with type 2 diabetes.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

1.1、签署知情同意时，18 岁≤年龄≤75 岁，性别不限； 2、确诊为2型糖尿病（根据2019年WHO诊断标准），病程3个月以上，且同时满足7.5% ≤糖化血红蛋白（HbAlc）≤11.0%； 3、筛选前2个月内生活方式干预或使用稳定剂量二甲双胍（≥1000 mg/d或个体最大耐受剂量，且个体最大耐受剂量应≥500mg/d）治疗者，且最大耐受剂量需有既往病历记录支持； 4、受试者（包括伴侣）自筛选至完成试验后6个月内无生育计划，且愿采用方案规定的避孕措施（（见附录6）），试验完成后6个月内无捐献精子、卵子计划； 5、对本研究已充分了解，自愿参加，已签署书面的知情同意书； 6、受试者能够和研究者进行良好的沟通，并且理解和遵守本研究的各项要求。；

Inclusion criteria

1.1. At the time of signing the informed consent, age ≤ 18 years old, age ≤75 years old, gender unlimited;
2.2, diagnosed with type 2 diabetes (according to the 2019 WHO diagnostic criteria), the course of disease is more than 3 months, and at the same time meet 7.5% ≤ HbAlc ≤11.0%;
3.3. Lifestyle intervention or stable dose of metformin (≥1000 mg/d or the maximum tolerated dose of the individual, and the maximum tolerated dose of the individual should be ≥500mg/d) within 2 months before screening, and the maximum tolerated dose should be supported by previous medical records;
4.4. The subjects (including their partners) have no family planning within 6 months after the completion of the test, and are willing to use the contraceptive measures specified in the program (see Appendix 6)), and have no plans to donate sperm or eggs within 6 months after the completion of the test;
5.5. Have fully understood this study, voluntarily participated in it, and have signed a written informed consent;
6.6. The subjects were able to communicate well with the researchers, and understood and complied with the requirements of the study.;

排除标准：

1.1、已知对本试验用药或其制剂辅料过敏或对其它GLP-1受体激动剂类药物过敏者，或既往有临床显著的多种或严重药物过敏史者，或现症过敏疾患者或高敏体质者； 2、体重指数（BMI）≤20.0 kg/m2； 3、既往使用以下任何一种药物或治疗者： 1) 筛选前2个月内接受二甲双胍外的其它降糖药或全身性糖皮质激素（口服或注射）治疗者，以下情况除外：筛选前2个月内曾用胰岛素短期治疗累计≤10天或糖皮质激素治疗累计≤2周，且用药结束时间距离筛选首日＞7个半衰期； 2) 筛选前3个月内使用过GLP-1受体激动剂(GLP-1R)或GLP-1R/GCGR激动剂或GLP-1R/GIPR/GCGR激动剂，或筛选前3个月以上因为缺乏疗效或不能耐受而停用上述药物的患者； 3) 筛选前3个月内使用非处方减肥药或食物抑制剂（包括中药），或筛选前3个月内使用减肥处方药（包括但不限于奥利司他、芬特明、马吲哚）或脂质溶解注射剂（例如：溶脂针）治疗； 4) 筛选时持续使用中枢神经兴奋剂(如盐酸哌甲酯)，含咖啡因饮料除外； 5) 筛选前1个月内接种过减毒活疫苗或新冠疫苗，或计划在试验期间接种疫苗者。 4、有以下任何一种疾病的病史或证据者： 1) 诊断为1型糖尿病； 2) 有甲状腺髓样癌（MTC）或2型多发性内分泌腺瘤病（MEN2）个人既往史或家族史（一级亲属内，即父母、子女或兄弟姐妹）者； 3) 筛选前6个月内有临床意义的、活动性的心脑血管疾病者，定义为：ⅰ心肌梗塞（MI）或不稳定性心绞痛；ⅱ心脏相关手术（含冠状动脉旁路移植术、经皮冠状动脉介入治疗）；ⅲ充血性心力衰竭（纽约心脏病学会[NYHA]分级为Ⅲ-IV级）；ⅳ脑血管意外（陈旧性腔隙性脑梗塞除外），包括但不限于中风/短暂性脑缺血发作；ⅴ经研究者评估其它不适合参加本实验的心脑血管疾病。 4) 筛选前6个月内发生急性胰腺炎或既往有慢性胰腺炎、胰腺手术病史； 5) 筛选前6个月内出现糖尿病急性代谢紊乱（包括糖尿病酮症酸中毒、高渗高血糖综合征）者； 6) 曾有严重低血糖昏迷病史或者入组前2个月内曾有频繁低血糖（≥1次/周，指尖或静脉血＜3.9mmol/L）者； 7) 筛选期有增殖性糖尿病视网膜病变、糖尿病黄斑病变或需要急性治疗的严重非增殖性糖尿病视网膜病变者； 8) 有明显的肝脏疾病、急慢性肝炎的临床体征或症状； 9) 合并有胃轻瘫或其他胃肠排空障碍相关疾病（如幽门梗阻、肠梗阻等）、未控制的胃食管反流病、研究者评估为增加用药后风险的胃肠道疾病（如严重的活动性溃疡、炎症性肠病、胃食管反流病、急性胃肠炎、症状性慢性胃肠炎、功能性胃肠病、肠结核等）； 10) 筛查前1个月内有大中型手术、严重创伤、严重感染，经研究者判断不适合参加本研究者； 11) 筛选前5年内有恶性肿瘤病史（充分治疗的宫颈原位癌、基底细胞或鳞状上皮细胞皮肤癌、根治术后的局部前列腺癌、根治术后的乳腺导管原位癌除外）者； 12) 并发其他疾病，如神经系统、内分泌系统、精神疾病等，研究者认为影响疗效评价或依从性差者。 5、筛选时有符合下列标准的任何检查异常且经研究者判断有临床意义者： 1) 肝、肾功能损害，根据各医院实验室的参考值指标，血清ALT、AST超过参考值范围上限2.5倍。血清总胆红素超过参考值范围上限的1.5倍；肾小球滤过率估测值（eGFR）＜60ml?min-1?1.73m-2。eGFR=175×Scr-1.234（mg/dl）×年龄-0.179（女性×0.79），Scr单位换算：1mg/dl＝88.4μmol/L）； 2) 血清降钙素≥20pg/mL（即20ng/L）； 3) 甲状腺功能异常，且经临床评估和/或TSH异常证实的甲状腺功能亢进或甲状腺功能减退，研究者认为可能增加患者的风险； 4) 空腹甘油三酯≥5.6mmol/L，若接受降脂药治疗，需筛选前30天剂量稳定； 5) 血清淀粉酶或脂肪酶＞2.0×ULN； 6) 筛选时凝血酶原时间国际标准化比值(INR)大于正常范围上限； 7) 未经治疗或控制不佳的高血压（筛选时收缩压≥160 mmHg和/或舒张压≥100mmHg）； 8) 严重的心电图异常，定义为a）二度或三度房室传导阻滞；b）长QT综合征或QTcF > 450ms(计算公式见附录1)；c）PR间期< 120ms或PR间期> 220ms；d）QRS > 120ms；e)左右束支阻滞；f）预激综合征，或g)需要治疗的严重心律失常；h）心率＜50次/min或＞100次/min； 9) 体格检查、生命体征、实验室检查等显示异常有临床意义，且经研究者判断可能对受试者构成重大风险或干扰对安全性、PK或PD结果评价而不适宜参加该试验者。 6、筛选时乙型肝炎表面抗原检查阳性、丙型肝炎病毒抗体检查阳性、人免疫缺陷病毒抗体检查阳性或梅毒抗体检查阳性者； 7、筛选前接受过任何减肥手术者或筛选前6个月内接受过任何对试验评估产生影响的手术者； 8、筛选前3个月内失血或献血超过400 mL，或接受过血液或血液成份输注者；或并发血红蛋白病、溶血性贫血、镰状细胞性贫血或血红蛋白<110g/L(男性)或<100g/L(女性)； 9、筛选前3个月内参加过其它临床试验者（仅参加筛选但未入组或非干预性研究除外）； 10、既往有药物滥用史，或尿药筛查阳性者； 11、首次给药前28天内女性每周饮酒超过7杯或男性每周饮酒超过14杯（1杯=150mL（5盎司）葡萄酒=360mL（12盎司）啤酒=45mL（1.5盎司）烈酒），或首次给药前48小时内服用过任何含酒精的制品，或基线访视时酒精呼气试验为阳性者，或试验期间不能禁酒者； 12、“哺乳期女性”或“妊娠期女性”者； 13、不能耐受静脉穿刺者，有晕针或晕血史者； 14、筛选前3个月内体重变化＞5%，且试验期间不能保持规律的运动和饮食； 15、研究者认为其他不适合参加临床试验的其他情况。；

Exclusion criteria：

1.1. People who are known to be allergic to the drug used in this study or its adjuvants or to other GLP-1 receptor agonists, or who have a clinically significant history of multiple or severe drug allergies, or who have current allergic disorders or hypersensitive constitution;
2.2. Body mass index (BMI) ≤20.0 kg/m2;
3.3. Past use of any of the following drugs or treatments 1) Patients who received other hypoglycemic agents other than metformin or systemic glucocorticoids (oral or injection) within 2 months before screening, except for the following conditions: short-term insulin treatment accumulated ≤10 days or glucocorticoid treatment accumulated ≤2 weeks within 2 months before screening, and the end time of medication from the first day of screening > 7 half-lives； 2) Patients who have used GLP-1 receptor agonists (GLP-1R) or GLP-1R/GCGR agonists or GLP-1R/GIPR/GCGR agonists within 3 months prior to screening, or who have stopped using these drugs more than 3 months prior to screening due to lack of efficacy or intolerance； 3) Use of over-the-counter weight loss drugs or food inhibitors (including Chinese medicines) within 3 months prior to screening, or use of weight loss prescription drugs (including but not limited to orlistat, phentermine, marindole) or lipidolytic injections (e.g., lipidolytic needles) within 3 months prior to screening； 4) Continuous use of central nervous stimulants (such as methylphenidate hydrochloride) during screening, except caffeinated beverages； 5) Those who had received live attenuated vaccine or COVID-19 vaccine within 1 month prior to screening, or planned to receive vaccine during the trial.;
4.4, have a history or evidence of any of the following diseases: 1) diagnosed with type 1 diabetes； 2) Previous personal or family history of medullary thyroid cancer (MTC) or multiple type 2 (MEN2) (within a first-degree relatiendocrine adenomatosisve, i.e. parents, children or siblings)； 3) Patients with clinically significant and active cardiovascular and cerebrovascular diseases within 6 months before screening were defined as myocardial infarction (MI) or unstable angina pectoris； ⅱ Heart-related surgery (including coronary artery bypass grafting, percutaneous coronary intervention)； ⅲ Congestive heart failure (New York College of Cardiology [NYHA] grade III-IV)； Cerebrovascular accidents (excluding old lacunar infarction), including but not limited to stroke/transient ischemic attack, 4, 4； ⅴ Other cardiovascular and cerebrovascular diseases that are not suitable for participation in the experiment shall be evaluated by researchers. 4) Acute pancreatitis or a history of chronic pancreatitis or pancreatic surgery within 6 months before screening； 5) Diabetic acute metabolic disorders (including diabetic ketoacidosis and hyperosmolar hyperglycemia syndrome) occurred within 6 months before screening； 6) Had a history of severe hypoglycemia coma or had frequent hypoglycemia (≥ once/week, fingertip or venous blood < 3.9mmol/L) within 2 months before enrollment； 7) Patients with proliferative diabetic retinopathy, diabetic macular degeneration or severe non-proliferative diabetic retinopathy requiring acute treatment during the screening period； 8) Have obvious clinical signs or symptoms of liver disease, acute and chronic hepatitis； 9) Patients with gastroparesis or other gastroenterovoid-related disorders (e.g., pyloric obstruction, intestinal obstruction, etc.), uncontrolled gastroesophageal reflux disease, or gastrointestinal diseases (e.g., severe active ulcers, inflammatory bowel disease, gastroesophageal reflux disease, acute gastroenteritis, symptomatic chronic gastroenteritis, functional gastroenteropathy, intestinal tuberculosis, etc.) assessed by researchers as increasing the risk of medication； 10) Patients with large and medium-sized operations, severe trauma, and serious infection within 1 month before screening are judged not to be eligible to participate in this study by the researcher； 11) Patients with a history of malignant tumors within 5 years prior to screening (except for fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery)； 12) Complicated with other diseases, such as nervous system, endocrine system, mental diseases, etc., which researchers believe affect the efficacy evaluation or poor compliance.;
5.5. Patients with any abnormal examination meeting the following criteria and judged by the researchers to have clinical significance during screening: 1) liver and kidney function damage, serum ALT and AST exceeded the upper limit of the reference value range by 2.5 times according to the reference value indexes of the laboratory in various hospitals. Serum total bilirubin exceeding 1.5 times the upper limit of the reference value range1） The estimated glomerular filtration rate (eGFR) was < 60ml?min-1?1.73m-2. eGFR=175× SCR-1.234 (mg/dl) × age-0.179 (female ×0.79), Scr unit conversion: 1mg/dl = 88.4μmol/L)； 2) Serum calcitonin ≥20pg/mL (i.e. 20ng/L)； 3) Abnormal thyroid function, hyperthyroidism or hypothyroidism confirmed by clinical evaluation and/or abnormal TSH, which the investigator believes may increase the risk of the patient； 4) Fasting triglyceride ≥5.6mmol/L, if receiving lipid-lowering drug treatment, the dose should be stable 30 days before screening； 5) Serum amylase or lipase > 2.0×ULN； 6) The International normalized ratio of prothrombin time (INR) during screening was greater than the upper limit of the normal range； 7) Untreated or poorly controlled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100mmHg at screening)； 8) Severe electrocardiogram abnormalities, defined as a) second or third degree atrioventricular block； b) Long QT syndrome or QTcF > 450ms(see Appendix 1 for the calculation formula) c) PR interval < 120ms or PR interval > 220ms d) QRS > 120ms e) Left and right bundle branch block f) pre-excitation syndrome, or g) severe arrhythmia requiring treatment h) Heart rate < 50 beats /min or > 100 beats /min 9) Physical examination, vital signs, laboratory examination, etc., showed abnormalities of clinical significance, and the investigator judged that it may pose a major risk to the subjects or interfere with the evaluation of safety, PK or PD results, so the participants were not suitable to participate in the trial.;
6.6, screening hepatitis B surface antigen test positive, hepatitis C virus antibody test positive, human immunodeficiency virus antibody test positive or syphilis antibody test positive;
7.7. Patients who had undergone any bariatric surgery prior to screening or had undergone any surgery within 6 months prior to screening that had an impact on the trial evaluation;
8.8, blood loss or blood donation more than 400 mL within 3 months before screening, or received blood or blood component infusion Or complicated with hemoglobinopathy, hemolytic anemia, sickle cell anemia, or hemoglobin <110g/L(male) or <100g/L(female);
9.9. Participants who participated in other clinical trials within 3 months prior to screening (except for screening but not enrolled or non-interventional studies);
10.10, have a history of drug abuse, or urine drug screening positive;
11.11. Drank more than 7 drinks per week for women or 14 drinks per week for men (1 drink =150 ml (5 oz) wine =360mL (12 oz) beer =45mL (1.5 oz) spirits) in the 28 days prior to first dosing, or consumed any alcoholic product in the 48 hours prior to first dosing, Or who had a positive alcohol breath test at baseline visit, or who could not abstain during the test;
12.12. "lactating women" or "pregnant women";
13.13. Patients who cannot tolerate venipunction, have a history of needle fainting or blood fainting;
14.14. Weight change > 5% in the 3 months before screening, and regular exercise and diet cannot be maintained during the trial;
15.15. Other conditions deemed unsuitable for participation in clinical trials by the investigator.;

研究实施时间：

Study execute time：

从 From 2023-10-08 00:00:00至 To 2025-09-30 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2024-07-01 00:00:00 至 To 2025-09-30 00:00:00

干预措施：

Interventions：

组别：

A1或B1

样本量：

 12

Group：

A1 or B1

Sample size：

干预措施：

10:2比例随机皮下注射UBT251或安慰剂。

干预措施代码：

Intervention：

A ratio of 10:2 was randomly injected subcutaneously with UBT251 or placebo.

Intervention code：

组别：

A3或B3

样本量：

 12

Group：

A3 or B3

Sample size：

干预措施：

10:2比例随机皮下注射UBT251或安慰剂。

干预措施代码：

Intervention：

A ratio of 10:2 was randomly injected subcutaneously with UBT251 or placebo.

Intervention code：

组别：

A2或B2

样本量：

 12

Group：

A2 or B2

Sample size：

干预措施：

10:2比例随机皮下注射UBT251或安慰剂。

干预措施代码：

Intervention：

A ratio of 10:2 was randomly injected subcutaneously with UBT251 or placebo.

Intervention code：

组别：

A4或B4

样本量：

 12

Group：

A4 or B4

Sample size：

干预措施：

10:2比例随机皮下注射UBT251或安慰剂。

干预措施代码：

Intervention：

A ratio of 10:2 was randomly injected subcutaneously with UBT251 or placebo.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 中南大学湘雅二医院 

单位级别：

 三级甲等 

Institution
hospital：

Second Xiangya Hospital of CSU

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 岳阳市人民医院 

单位级别：

 三级甲等 

Institution
hospital：

People's hospital of YueYang

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三级甲等 

Institution
hospital：

The Third Xiangya Hospital Central South University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 益阳市中心医院 

单位级别：

 三级甲等 

Institution
hospital：

Yiyang Central Hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 江西 

市(区县)：

  

Country：

China

Province：

Jiangxi

City：

单位(医院)：

 萍乡市人民医院 

单位级别：

 三级甲等 

Institution
hospital：

pingxiang people's hospital

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 河北医科大学第一医院 

单位级别：

 三级甲等 

Institution
hospital：

the first hospital of hebei medical university

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河北 

市(区县)：

  

Country：

China

Province：

Hebei

City：

单位(医院)：

 河北医科大学第四医院 

单位级别：

 三级甲等 

Institution
hospital：

The Fourth Hospital of Hebei Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

  

Country：

China

Province：

Henan

City：

单位(医院)：

 河南科技大学第一附属医院 

单位级别：

 三级甲等 

Institution
hospital：

The first affiliated Hospital of henan university of science & technology

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 河南 

市(区县)：

  

Country：

China

Province：

Henan

City：

单位(医院)：

 郑州人民医院 

单位级别：

 三级甲等 

Institution
hospital：

PEOPLE'S HOSPITAL OF ZHENGZHOU

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

空腹血糖

指标类型：

次要指标

Outcome：

Fasting blood glucose

Type：

Secondary indicator

测量时间点：

D1、D29、D57、D78给药前及D1给药后48h

测量方法：

葡萄糖氧化酶方法

Measure time point of outcome：

Before administration of D1, D29, D57, D78 and 48h after administration of D1

Measure method：

Glucose oxidase method

指标中文名：

原形药物的药物浓度

指标类型：

次要指标

Outcome：

The drug concentration of the original drug

Type：

Secondary indicator

测量时间点：

D1、D29、D57、D78空腹给药前及给药后12h、24h、48h、72h以及D8、D15、D22、D36、D43、D50、D64、D71空腹给药前及D85

测量方法：

LC-MS/MS

Measure time point of outcome：

D1, D29, D57, D78 before fasting and 12h, 24h, 48h, 72h after administration; D8, D15, D22, D36, D43

Measure method：

LC-MS/MS

指标中文名：

安全性评价

指标类型：

主要指标

Outcome：

Safety evaluation

Type：

Primary indicator

测量时间点：

全程

测量方法：

不良事件、不良反应、严重不良事件等及发生率

Measure time point of outcome：

Whole course

Measure method：

Adverse events, adverse reactions, serious adverse events and their incidence

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血浆

组织：

Sample Name：

plasma

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

标本中文名：

血液

组织：

Sample Name：

blood

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

标本中文名：

血清

组织：

Sample Name：

Serum

Tissue：

人体标本去向

 其它  

说明

Fate of sample：

0thers  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 75 岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

统计单位使用SAS 9.4（或以上版本）统计软件

Randomization Procedure (please state who generates the random number sequence and by what method)：

Statistical units use SAS 9.4 (or later) statistical software

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：

双盲。本研究采用双盲的设计，试验药和安慰剂外观，气味等一致，每个剂量组试验用药品均使用相同的外包装盒，每名受试者者使用相同编号的试验用药品。药物现场编盲由统计单位人员和申办方与本试验无关人员参加，随机号即作为药物盲法实施的药物号，将已形成的随机号（药物号）填写（或粘贴）在标签上。编盲过程形成编盲记录保存。 本研究采用的是纸质应急信件，每位受试者一份应急信件。信件内密封有随机号对应的组别，应急信件随对应的试验用药品发往研究中心。 紧急情况下，研究者认为知晓受试者所服用试验用药品有利于不良事件的处理时，可拆阅应急信件紧急揭盲。同时在拆阅的应急信件上也应由拆阅的研究者注明紧急破盲的原因、日期并签字。 本研究揭盲于统计分析计划书、数据审核报告定稿并数据库锁定后进行，揭晓随机号所对应的治疗，以便对全部数据进行分组后的统计分析。揭盲文件由主要研究者、申办方、统计人员共同签署。

Blinding：

Double blind. In this study, a double-blind design was adopted. The appearance and smell of the test drug were the same as that of the placebo. The test drug in each dose group was packaged in the same box, and the test drug with the same number was used for each subject.The personnel of the statistical unit and the sponsor who have nothing to do with this experiment participated in the drug field blinding. The random number is the drug number implemented as the drug blinding method, and the formed random number (drug number) is filled in (or pasted) on the label.The blind process forms blind record keeping. Paper emergency letters were used in this study, one emergency letter for each subject.The letters are sealed with the corresponding group of random numbers, and the emergency letters are sent to the research center with the corresponding experimental drugs. In emergency situations, when the investigator believes that knowing the experimental drug taken by the subject is conducive to the management of adverse events, the emergency letter can be opened and the blind can be urgently uncovered.At the same time, on the emergency letter opened, the researcher should also indicate the reason for the emergency breaking of blindness, the date and sign. This study was carried out after the statistical analysis plan and data review report were finalized and the database was locked, and the treatment corresponding to the random number was revealed for statistical analysis after grouping all the data.The Braille document shall be jointly signed by the principal investigator, sponsor and statistician.

是否共享原始数据：

IPD sharing

否No

共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：

NA

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

NA

数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：

电子采集和管理系统

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

EDC

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2024-06-12 14:35:16