A Phase 2 Study of Cyclo-Z in Subjects With Type 2 Diabetes

Inclusion Criteria: * Males or females aged 18 or older. * Subjects diagnosed with type 2 diabetes mellitus (DM) 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 and who agree to stay on stable doses of anti-diabetes agents during the study. * 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 and a fasting plasma glucose less than 310 mg/dL. * Subjects who can give written informed consent. * Subjects who are willing and able to monitor their blood glucose concentrations with a home glucose monitor (before breakfast and 2 hours after dinner). * Female subjects must be either: * Surgically sterile (i.e., have had bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 months before randomization, or * Post-menopausal for at least 12 months prior to Screening, or * If of childbearing potential and sexually active, must agree to use adequate contraception from Screening to completion of the study. Exclusion Criteria: * Subjects who have any significant 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 with evidence of clinically significant cardiovascular or cerebrovascular disease, including (but not limited to): * 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. * Stroke or transient ischemic attack in the past 12 months. * Subjects with uncontrolled hypertension with average systolic blood pressure of ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg at Screening and Baseline. * Subjects with pulse rate ≥ 95 beats per minute at Screening and Baseline. * Subjects who have or had any of the following conditions related to gastrointestinal disease: * Chronic hepatitis or cirrhosis. * Episode of alcoholic hepatitis or pancreatitis. * Inflammatory bowel disease or irritable bowel syndrome. * Significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months. * Serum creatinine ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females. * Hemoglobin ≤ 12 g/dL for males or ≤ 10 g/dL for females. * Subjects who have chronic obstructive airway disease or asthma requiring daily inhaled corticosteroid therapy or home use oxygen. * 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). * Use of illicit drugs or drugs of abuse. * 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 insulin sensitizers (thiazolidinediones - TZDs) such as Avandia, Actos or Duvie, etc. * Subjects with any other clinically significant and/or unexplained abnormalities that, in the opinion of the Investigator, could impact the subject's ability to fully participate in or complete the study. * Female subjects who have a positive serum pregnancy test at Screening, plan a pregnancy during study period, or are breast feeding.

Reproduced word-for-word from the public registry record — the study team can answer questions about it.