Development of A Novel Anti-Hyperglycemic Agent
Condition: Diabetes
Intervention: Cyclo-Z; Placebo
Intervention description: Cyclo-Z is a cyclic dipeptide Cyclo (his-pro) plus zinc that may lower blood glucose; Placebo control
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Diabetes; Cyclo-Z

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          1. History of type 2 diabetes mellitus who are na ve to hypoglycemic treatment,
             inadequately controlled by diet and exercise alone or oral medications.

          2. 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).

          3. Fasting blood glucose levels reasonably stable for at least 2 months or during the
             two-week lead-in-period.

          4. Ethnicity: All ethnic groups.

          5. Gender: Both men and women.

          6. Female with reproductive potential must not be pregnant or lactating, and using
             reliable contraception methods.

          7. Age >18 years old.

        Exclusion Criteria:

          1. Taking insulin.

          2. History of diabetic ketoacidosis or hyper osmolar non-ketotic coma.

          3. 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

          4. 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.

          5. Cardiovascular disease:

               -  Hospitalization for treatment of heart disease in the past 12 months.

               -  New York Heart Association Functional Class > 2.

               -  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.

          6. 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).

          7. Renal disease: Serum creatinine > 1.5 mg/dL for men, and > 1.4 mg/dL for women.

          8. Lung disease:

               -  Chronic obstructive airway disease or asthma requiring daily therapy.

               -  Use of home oxygen.

          9. Anemia: Hematocrit of < 36.0% in men or < 33% in women.

         10. 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)

         11. 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.