A Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes

Inclusion criteria

• 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.

Exclusion criteria

• 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 > 2.
• 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.