Clinical trial NCT00878605 (phase 2, status: terminated)
Conditions: diabetes
ICD codes: E23.2, N25.1, P70.2, O24.92, Z83.3, Z86.32, E10.65
Drugs: cyclo-z, placebo
SMILES: CN1C(=O)C=C(N2CCC[C@@H](N)C2)N(CC2=C(C=CC=C2)C#N)C1=O
Reason stopped: 
    unable to reach accrual target.
  
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.