Multicentre Double-blind Placebo-controlled Parallel Group Randomized Clinical Trial of Efficacy and Safety of Subetta in the Treatment of Impaired Glucose Tolerance
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 538
- 试验地点
- 44
- 主要终点
- Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
研究概览
简要总结
Purpose of the study:
- to assess the efficacy of Subetta in the treatment of impaired glucose tolerance
- to assess the safety of Subetta in the treatment of impaired glucose tolerance.
详细描述
Design: a multicenter, double-blind, placebo-controlled, parallel-group randomized trial.
The study will enroll outpatients adults aged 18 to 70 years with impaired glucose tolerance (IGT) who did not receive glucose-lowering agents previously. Persons with pre-diabetes, obesity (especially with visceral or abdominal obesity), dyslipidemia (with high triglycerides and/or low-density lipoproteins), hypertension, diabetes in first-degree relatives will be considered as potential candidates to participate in the study.
After the patient's information sheet and the form of informed consent for participation in the study are signed on the screening (visit 0; day from -7 to 0), complaints and history are collected, registration of concomitant conditions and diseases, objective examination, calculation of body mass index (BMI), oral glucose tolerance test (OGTT), fasting blood glucose. Furthermore, blood samples (for testing HbA1c, chemistry and hematology, HLA genotyping) and urine sample will be collected; concomitant therapy will be recorded, diet and physical activity recommendations will be given. All women of childbearing potential will be administered pregnancy tests.
If eligibility criteria are met and there are no non-inclusion criteria on Visit 1 (Day 1), the patient is randomized to one of two groups: the Subetta group (patients will take 2 tablets twice a day for 12 weeks) or placebo group (patients will take a placebo according to the scheme of Subetta for 12 weeks).
In the course of the study, two more visits in 4 (Visit 2) and 12 (Visit 3) weeks are planned, during these weeks complaints are recorded, a patient's examination is recorded, therapy compliance and safety are assessed. On Visit 3 OGTT, fasting blood glucose, blood samples (for HbA1c, chemistry and hematology) and urinalysis will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Outpatients aged 18 to 70 years.
- •Impaired glucose tolerance (plasma glucose from 7.8 to 11.0 mmol / L 2 hours after a 75 g oral glucose consumption during an oral glucose tolerance test, while fasting plasma glucose <7.0 mmol / L).
- •HbA1c is 5.7-6.4%.
- •The body mass index is 25.0-39.9 kg / m^
- •Consent to use reliable contraceptive methods during the study (for men and women with reproductive potential).
- •The presence of the signed informed consent form to participate in the clinical trial.
排除标准
- •Type 1 or type 2 diabetes.
- •Use of any medications indicated in the section "Prohibited concomitant medications".
- •Acute or exacerbation / decompensation of a chronic disease of any etiology at the time of the examination or during the previous week.
- •Uncontrolled arterial hypertension with blood pressure: systolic blood pressure > 160 mm Hg and/or diastolic blood pressure > 110 mm Hg.
- •Acute coronary syndrome, myocardial infarction, acute impairment of cerebral circulation during the previous 6 months prior to enrollment.
- •Unstable or life-threatening arrhythmia during the previous 3 months prior to enrollment.
- •Acute and chronic heart failure with functional class III or IV (according to the classification of the New York Heart Association, 1964).
- •Respiratory failure.
- •Chronic kidney disease (classes C3-5 A3).
- •Hepatic insufficiency (class C according to Child-Pugh).
- •Presence or suspicion of oncology disease.
- •The presence of an allergy / hypersensitivity to any component of the medication administered during the treatment.
- •Alcohol consumption > 2 alcohol units for males and > 1 alcohol unit for females per day.
- •Mental illness or drug abuse in anamnesis.
- •Bariatric surgery in anamnesis, any surgery for 3 months before enrollment.
- •Pregnancy, breast-feeding; childbirth less than 3 months before enrollment.
- •Participation in other clinical trials for 3 months before enrollment in this study.
- •Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
- •Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
研究组 & 干预措施
Subetta
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
干预措施: Subetta (Drug)
Placebo
Tablet for oral use. 2 tablets twice daily. The tablets should be held in mouth until completely dissolved 15 min prior to meal.
干预措施: Placebo (Drug)
结局指标
主要结局
Change 2-hour Plasma Glucose (During Oral Glucose Tolerance Test).
时间窗: At baseline and after 12 weeks of treatment.
Based on medical records. For oral glucose tolerance test, the subject is given 75 g of oral glucose and blood sample is taken 2 hours later. All analysis will be done in a central laboratory.
次要结局
- Change in Fasting Plasma Glucose.(At baseline and after 12 weeks of treatment.)
- Change in HbA1c(At baseline and after 12 weeks of treatment.)
- Percentage of Patients With 2-hour Plasma Glucose <7.8 mmol / L.(After 12 weeks of treatment.)