Development of A Novel Anti-Hyperglycemic Agent
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- Hemoglobin A1C
研究概览
简要总结
The purpose of this clinical trial is to test the effectiveness and safety of a new anti-diabetes drug (Cyclo-Z) for the prevention and treatment of Type 2 diabetes. This study will determine dose-dependent efficacy and safety of this new drug for the treatment of human diabetes. The Food and Drug Administration has granted approval for the use of this investigational product to be used in a study [FDA approval (Investigational New Drug) IND #: 61,897]. This new drug is thought to work by increasing the amount of zinc in your body, which in turn should improve your sugar metabolism. If this study successfully proves that Cyclo-Z is effective for the treatment of diabetes and is without significant side effects, a large, multi-center study of diabetic patients will then be performed.
详细描述
We have demonstrated that a cyclic dipeptide Cyclo (his-pro) plus zinc (Cyclo-Z) treatment improved clinical conditions of diabetes in various animal models and a phase 1 clinical trial. The main objective of this study is to demonstrate that this product is safe and effective for the treatment of human diabetes.
Research Plan This is a randomized, double blinded, placebo-controlled, and parallel study. In this study, we will recruit 120 hypoglycemic drug na ve type 2 diabetic patients and randomize them into 4 groups of 30 subjects each to compare the effects of a Cyclo-Z capsule containing Cyclo-His Pro (CHP) 0 (placebo), 3 mg (minimally effective), 9 mg (optimally effective), or 15 mg (no-additional effect) plus 20 mg zinc on diabetic symptoms in a 12-week trial period. The primary outcome of this study is improvement of hemoglobin A1c; secondary outcomes are fasting blood glucose, 2 hours postprandial glucose and glucose tolerance test. Safety will be assessed by the presence of severe adverse events (SAEs), adverse events (AEs), any changes of vital signs, physical exams, blood hematology, chemistry, liver, renal, thyroid function tests, urine analysis and zinc, copper levels.
Clinical Significance The proposed study has a direct impact on veteran's healthcare service. The applicant has obtained two types of US and international patent approvals for preventing and treating human diabetes and obesity with Cyclo-Z. One patent application for Alzheimer's disease treatment has just been approved. These patent rights are now assigned to the DVA. Based on our background studies and observation we anticipate the proposed Phase 2a clinical trials will prove that Cyclo-Z treatment is safe and effective for the treatment of human diabetes and we will be able to present a new class of anti-diabetes drug to improve healthcare of both the VA diabetic patients and the general public.
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
- Double (Participant, Investigator)
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
- •History of type 2 diabetes mellitus who are na ve to hypoglycemic treatment, inadequately controlled by diet and exercise alone or oral medications.
- •Hemoglobin A1c level of 6.5 % to 8.0 % inclusive. Subjects not taking hypoglycemic drugs with HgbA1c of 6.0% to 6.5% must have a diagnosis of Diabetes Mellitus (DM).
- •Fasting blood glucose levels reasonably stable for at least 2 months or during the two-week lead-in-period.
- •Ethnicity: All ethnic groups.
- •Gender: Both men and women.
- •Female with reproductive potential must not be pregnant or lactating, and using reliable contraception methods.
- •Age >18 years old.
排除标准
- •Taking insulin.
- •History of diabetic ketoacidosis or hyper osmolar non-ketotic coma.
- •Diabetes Mellitus related end-organ damage:
- •Evidence of diabetic autonomic and peripheral neuropathy
- •Diabetic proliferative retinopathy, based on eye exam by ophthalmologist
- •Diabetes nephropathy defined by > 500 mg/24 hour urinary albumin excretion
- •Any disease likely to limit life span and/or increase risks of interventions:
- •Screening carotid B-mode ultrasound indicating clinically significant stenos in the common carotid arteries requiring intervention by angioplasty or resection.
- •Cancer treatment in the past 5 years, with the exception of cancers that have been cured, and carry a good prognosis.
- •Infectious disease: HIV positivity, active tuberculosis, or pneumonia.
- •Cardiovascular disease:
- •Hospitalization for treatment of heart disease in the past 12 months.
- •New York Heart Association Functional Class >
- •Left Bundle branch block on EKG.
- •Third degree atrioventricular block on EKG.
- •Uncontrolled hypertension with average systolic blood pressure of > 160 mmHg on two screening visits and diastolic blood pressure > 95 mmHg on two screening visit.
- •Pulse rate > 95 beats per minute on both screening visits.
- •Stroke or transient ischemic attack in the past 12 months.
- •Gastrointestinal disease:
- •Chronic hepatitis or cirrhosis.
- •Episode of alcoholic hepatitis or alcoholic pancreatitis.
- •Inflammatory bowel disease requiring treatment in the past 12 months.
- •Recent or significant abdominal surgery (e.g. gastrectomy, gastric bypass).
- •Renal disease: Serum creatinine > 1.5 mg/dL for men, and > 1.4 mg/dL for women.
- •Lung disease:
- •Chronic obstructive airway disease or asthma requiring daily therapy.
- •Use of home oxygen.
- •Anemia: Hematocrit of < 36.0% in men or < 33% in women.
- •Conditions or behaviors likely to affect the conduct of the study
- •Unable or unwilling to give informed consent.
- •Unable to communicate with the clinic staff.
- •Unwilling to accept treatment assignment by randomization.
- •Weight loss of > 10% in the past 6 months.
- •Unable to walk without any assisted device.
- •Major psychiatric disorder which would impede conduct of the research.
- •Excessive alcohol intake (more than 2 drinks/day)
- •Medications
- •Psychoactive agents such as Monoamine oxidase inhibitors and Antidepressive agents (lithium, prozac, zoloft, serzone, paxil, effexor)
- •Systemic use of glucocorticoids steroids within previous 6 weeks.
研究组 & 干预措施
Cyclo-Z (minimally effective)
3mg CHP plus 20mg zinc containing gel capsule;
干预措施: Cyclo-Z (Drug)
Cyclo-Z (maximally effective)
9mg CHP plus 20mg zinc containing gel capsule;
干预措施: Cyclo-Z (Drug)
Cyclo-Z (not additionally effective)
15mg CHP plus 20mg zinc containing gel capsule
干预措施: Cyclo-Z (Drug)
Placebo (for CHP)
Placebo capsules containing no zinc or CHP
干预措施: Placebo (Drug)
结局指标
主要结局
Hemoglobin A1C
时间窗: Baseline and Week 12
% change HgbA1c from baseline to 12 weeks.
次要结局
未报告次要终点