CTRI/2023/01/048723进行中（未招募）3 期
A Randomized, Double-Blinded, Placebo-Controlled, Parallel Study to Assess the Effects of Deglusterol on Fasting Glucose and Other Cardiometabolic Risk Factors.
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 4
- 主要终点
- Fasting plasma glucose will be assessed at baseline (Day 0), Day 14 and Day 28
研究概览
简要总结
The clinicaltrial is a randomized, double-blinded, placebo-controlled, parallel,multi-center study. A total of 70 male and female subjects, diagnosed withprediabetes (ages 20 to 75 years, inclusive), will be enrolled.
On the first dayof the 4-week screening period3 (Day -28), subjects will be screened according tothe study inclusion and exclusion criteria. Male subjects can be screenedwithin 4 weeks prior to randomization (Day 0). Subjects meeting all theinclusion criteria and none of the exclusion criteria will be invited toparticipate in the study. Subjects who provide written informed consent toparticipate in the study will be randomized either to the Deglusterol group orthe placebo group in a 1:1 ratio. Each group will consist of 35 subjects.
On the day ofrandomization (Day 0), blood samples for the assessment of primary and secondaryoutcomes will be collected (i.e., as baseline measures) and an OGTT will be conducted.Subjects will be asked to return 2 and 4 weeks after the baseline visit.Therefore, each subject will be required to make a total of 4 visits to theclinical research site (i.e., Days -28, 0, 14, and 28).
The study willcommence only after obtaining written approval from the site InstitutionalEthics Committee.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects will be considered eligible to participate in the study if they meet all the following inclusion criteria
- •Males and females between 20 to 75 years of age (inclusive) of any ethnicity.
- •One who satisfies at least one of the following prediabetic criteria a.
- •IFG A fasting blood glucose of 100 mg per dL and 125 mg per dL b.
- •Prediabetes HbA1c between 5.7 percent and 6.4 percent
- •Body mass index less than35 kg per m
- •Vital signs are normal, or deemed abnormal but clinically insignificant by the Investigator.
- •Clinical laboratory evaluations including clinical chemistry, hematology, and UA are normal or deemed clinically insignificant by the Investigator.
- •Males who are sterile or agree to use an approved method of contraception, with an approved method of contraception considered a barrier method (diaphragm, cervical cap, or condom) plus a contraceptive jelly spermicidal foam, gel, film, cream, or suppository.
- •If the female sexual partner of the male is using an approved form of contraception (see inclusion criterion 8) or is not of childbearing potential, the male is not required to be sterile or if not sterile, to use an approved form of contraception.
- •Female subjects who are postmenopausal (absence of menses for 1 year or more), women who are surgically sterilized, or women of child-bearing potential who are nonlactating and have been using an effective form of birth control for a minimum of 6 months prior to screening and agree to continue using the effective form of birth control during the study and for 30 days after the treatment period (effective forms of birth control include oral pills with concentration of at least 50 µg of the estrogenic component of a biphasic or triphasic pill; transdermal, injectable, or implantable contraceptive intrauterine device per intrauterine system or double-barrier method (for example diaphragm and condom).
- •WOCBP who are using low dose oral birth control must also use a barrier method of contraception for the duration of the study.
- •Subjects who, during the investigative period, are willing to a.
- •Consume the prescribed test products.
- •Avoid physical activity for at least 12 hours prior to each clinic visit.
- •Maintain their habitual diet and level of physical activity.
- •Fast for a minimum of 12 hours prior to each clinic visit.
- •Subjects who, during the investigative period, are not planning to participate in intense physical activity (for example marathon).
- •Subjects who are capable of providing informed consent and complying with all study procedures per requirements.
排除标准
- •Subjects will be considered ineligible to participate in the study if they meet one or more of the following exclusion criteria:
- •A diagnosis of diabetes.
- •Use of hypoglycemic agents (e.g., sulfonylurea, non-sulfonylurea, biguanide, a-glucosidase inhibitor, thiazolidinedione, GLP-1 agonist, DPP4 inhibitor, insulin) or other therapies, such as medicinal herbs, that may aid in the reduction of blood glucose or insulin.
- •Use of frequent systemic glucocorticoids (>4 courses), or growth hormone, or had a transplant of any type or cystic fibrosis or any other therapy or current use of any medication which causes rise in plasma glucose level.
- •A creatinine level >2X the normal upper limit of the testing institution.
- •Uncontrolled thyroid disease or hypertension (i.e., systolic blood pressure 160 mmHg and/or diastolic blood pressure greater than or equal to100 mmHg).
- •Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease (angina pectoris, myocardial infarction, heart failure, arrhythmia in need of treatment) within 6 months of the test or any other disease.
- •Current use of medication or medical device treatment for schizophrenia, depression, drug addiction, or alcoholism.
- •Participation in clinical trials/human studies within 1 month of the start of this study and received other medicines or has applied other medical devices.
- •Person who is expected to receive other medicines or applied medical devices by participating in other clinical trials/human studies during the participation period in this study.
- •Women who plan to become pregnant during the study, are pregnant or lactating, or were pregnant or nursing within the past year.
- •Subject who resides in the same household as another subject already participating in the study.
- •Subjects who test positive at screening for recreational drugs/alcohol.
- •Subjects who have any condition or showing symptoms of a condition that would make them, in the opinion of the Investigator, unsuitable for the study.
结局指标
主要结局
Fasting plasma glucose will be assessed at baseline (Day 0), Day 14 and Day 28
时间窗: Day 0, 14 & 28.
次要结局
- The secondary endpoints will be assessed at baseline (Day 0), Day 14 and Day 28 and OGTT will be assessed only at Day 0 and Day 28(Fasting plasma insulin;)
研究者
研究点 (4)
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