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

Inclusion Criteria:

1. Males or females aged 18 or older.

2. Subjects diagnosed with type 2 diabetes mellitus according to the American Diabetes
Association (ADA) criteria.

3. 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.

4. Subjects whose fasting blood glucose levels are reasonably stable for at least 2
months prior to randomization and during the 2-week screening period.

5. Subjects who have Hemoglobin A1c levels of 7.5 to 10.0 % at Screening.

6. Subjects whose BMI is 30 or above.

7. Subjects who can give written informed consent.

Exclusion Criteria:

1. Subjects who have any DM-related end-organ damages.

2. Subjects who have a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.

3. 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.

4. 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.

5. 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.

6. Subjects who have serum creatinine > 1.5 mg/dL for male or > 1.4 mg/dL for female.

7. Subjects who have chronic obstructive airway disease or asthma requiring daily therapy
or home use oxygen.

8. Subjects who have hematocrit < 36.0% for male or < 33.0% for female.

9. 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).

10. 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.

11. Female subjects who have a positive serum pregnancy test at Screening, plan a
pregnancy during study period, or are breast feeding.

12. 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.