NCT02784275已完成2 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 64
- 主要终点
- Change of HbA1c Level From Baseline
研究概览
简要总结
This is a double-blind, randomized, placebo-controlled, parallel-group comparison study to evaluate the efficacy and safety of Cyclo-Z for the treatment of subjects with obese type 2 diabetes.
The study will consist of 3 phases:
- Screening phase (2 weeks)
- Treatment phase (12 weeks)
- Follow-up phase (2 weeks)
Following a 2-week screening period, subjects who meet all inclusion and exclusion criteria will be randomly assigned into one of the following treatment arms:
- Dose A: Cyclo-Z containing 23 mg zinc plus 3 mg CHP - 16 subjects
- Dose B: Cyclo-Z containing 23 mg zinc plus 9 mg CHP - 16 subjects
- Dose C: Cyclo-Z containing 23 mg zinc plus 15 mg CHP - 16 subjects
- Dose D: Placebo - 16 subjects
The assigned dose will be orally administered to subjects once a day before bedtime for 12 consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their respective trial sites at Weeks 2, 4, 6, 8, 10, 12, and 14 (Visits 3, 4, 5, 6, 7, 8, and 9).
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged 18 or older.
- •Subjects diagnosed with type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria.
- •Subjects treated with stable doses of insulin and/or other hypoglycemic agent(s) for type 2 diabetes mellitus for at least 2 months prior to randomization.
- •Subjects whose fasting blood glucose levels are reasonably stable for at least 2 months prior to randomization and during the 2-week screening period.
- •Subjects who have Hemoglobin A1c levels of 7.5 to 10.0 % at Screening.
- •Subjects whose BMI is 30 or above.
- •Subjects who can give written informed consent.
排除标准
- •Subjects who have any DM-related end-organ damages.
- •Subjects who have a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
- •Subjects who have any disease likely to limit life span and/or increase risks of interventions such as:
- •Carotid B-mode ultrasound test results indicating clinically significant stenosis in the common carotid arteries requiring intervention by angioplasty or resection.
- •Cancer treatment in the past 5 years, with the exception of cancers which have been cured, and carry a good prognosis.
- •Infectious disease: HIV positivity, active tuberculosis, or pneumonia.
- •Subjects who have any of the following conditions related to cardiovascular disease:
- •Hospitalization for the treatment of heart disease in the past 12 months.
- •New York Heart Association Functional Class >
- •Left Bundle branch block on ECG at Screening.
- •Third degree atrioventricular block on ECG at Screening.
- •Uncontrolled hypertension with average systolic blood pressure of > 160 mmHg or diastolic blood pressure > 95 mmHg at Screening and Baseline.
- •Pulse rate > 95 beats per minute at Screening and Baseline.
- •Stroke or transient ischemic attack in the past 12 months.
- •Subjects who have any of the following conditions related to gastrointestinal disease:
- •Chronic hepatitis or cirrhosis.
- •Episode of alcoholic hepatitis or alcoholic pancreatitis in the past 2 months.
- •Inflammatory bowel disease requiring treatment in the past 12 months.
- •Significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months.
- •Subjects who have serum creatinine > 1.5 mg/dL for male or > 1.4 mg/dL for female.
- •Subjects who have chronic obstructive airway disease or asthma requiring daily therapy or home use oxygen.
- •Subjects who have hematocrit < 36.0% for male or < 33.0% for female.
- •Subjects who have any of the following conditions or behaviors likely to affect the conduct of the study:
- •Weight loss of > 10% in the past 6 months.
- •Unable to walk without assisted device.
- •Major psychiatric disorder which would impede conduct of the research.
- •Excessive alcohol intake (i.e., more than 2 drinks/day).
- •Subjects who take any of the following medications:
- •Psychoactive agents such as monoamine oxidase inhibitors and antidepressants (e.g., lithium, Prozac, Zoloft, Serzone, Paxil, Effexor).
- •Any other medications that may pose harm to the subject.
- •Female subjects who have a positive serum pregnancy test at Screening, plan a pregnancy during study period, or are breast feeding.
- •Female subjects who don't meet any of the following criteria:
- •Surgically sterile (i.e., have had bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 months before randomization.
- •Post-menopausal for at least 12 months prior to Screening.
- •If sexually active, they should use oral contraceptives, double barrier contraception (e.g., condom with spermicide), intrauterine device, or other methods approved by the Sponsor.
研究组 & 干预措施
Dose A
Experimental
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
干预措施: Cyclo-Z (Drug)
Dose B
Experimental
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
干预措施: Cyclo-Z (Drug)
Dose C
Experimental
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
干预措施: Cyclo-Z (Drug)
Dose D
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change of HbA1c Level From Baseline
时间窗: 12 weeks
Change in HbA1c from Day 1 to Week 12
Change of Body Weight From Baseline
时间窗: 12 weeks
Change in body weight from Day 1 to Week 12
次要结局
- Change of Fasting Plasma Glucose Level From Baseline(12 weeks)
- Proportion of Subjects Achieving HbA1c Goal of <7.0%(12 weeks)
- Proportion of Subjects Achieving HbA1c Goal of <6.5%(12 weeks)
- Change in Waist Circumference From Baseline(12 weeks)
- Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline(12 weeks)
- Change of Oral Glucose Tolerance Test From Baseline(12 weeks)
- Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline(12 weeks)
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