A Phase 2 Study of Cyclo-Z in Subjects With Type 2 Diabetes

This is an interventional treatment trial for Diabetes Mellitus, Type 2 Read More

Inclusion Criteria:

• Males or females aged 18 or older.
• Subjects diagnosed with type 2 diabetes mellitus (DM) 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 and who agree to stay on stable doses of anti-diabetes agents during the study.
• 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 and a fasting plasma glucose less than 310 mg/dL.
• Subjects who can give written informed consent.
• Subjects who are willing and able to monitor their blood glucose concentrations with a home glucose monitor (before breakfast and 2 hours after dinner).

• Female subjects must be either:

  • Surgically sterile (i.e., have had bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 months before randomization, or
  • Post-menopausal for at least 12 months prior to Screening, or
  • If of childbearing potential and sexually active, must agree to use adequate contraception from Screening to completion of the study.

Exclusion Criteria:

• Subjects who have any significant 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 with evidence of clinically significant cardiovascular or cerebrovascular disease, including (but not limited to):

  • Hospitalization for the treatment of heart disease in the past 12 months.
  • New York Heart Association Functional Class > 2.
  • Left bundle branch block on ECG at Screening.
  • Third degree atrioventricular block on ECG at Screening.
  • Stroke or transient ischemic attack in the past 12 months.
• Subjects with uncontrolled hypertension with average systolic blood pressure of ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg at Screening and Baseline.
• Subjects with pulse rate ≥ 95 beats per minute at Screening and Baseline.

• Subjects who have or had any of the following conditions related to gastrointestinal disease:

  • Chronic hepatitis or cirrhosis.
  • Episode of alcoholic hepatitis or pancreatitis.
  • Inflammatory bowel disease or irritable bowel syndrome.
  • Significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months.
• Serum creatinine ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females.
• Hemoglobin ≤ 12 g/dL for males or ≤ 10 g/dL for females.
• Subjects who have chronic obstructive airway disease or asthma requiring daily inhaled corticosteroid therapy or home use oxygen.

• 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).
  • Use of illicit drugs or drugs of abuse.

• 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 insulin sensitizers (thiazolidinediones - TZDs) such as Avandia, Actos or Duvie, etc.
• Subjects with any other clinically significant and/or unexplained abnormalities that, in the opinion of the Investigator, could impact the subject's ability to fully participate in or complete the study.
• Female subjects who have a positive serum pregnancy test at Screening, plan a pregnancy during study period, or are breast feeding.