A Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes
Condition: Diabetes Mellitus Type 2 in Obese
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Intervention: Cyclo-Z; Placebo
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 64.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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).
    

Eligibility criteria:

        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.