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

• Status: Completed
• Trial end date: 2019-07-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a double-blind, randomized, placebo-controlled, parallel-group comparison study to evaluate the efficacy and safety of Cyclo-Z vs. placebo in adult subjects with type 2 diabetes. Approximately 20 clinical sites may be utilized in the United States so that approximately 300 subjects (a potential 20% screening failure rate) may be screened for total 28-week study period (2 weeks for screening, 24 weeks for treatment, and 2 weeks for safety follow-up).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NovMetaPharma Co., Ltd.
• Collaborators: FGK Clinical Research GmbH; InClin, Inc.

Criteria

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.