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

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus, Type 2

In brief

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).

Key facts

Study ID

NCT03560271

Run by

NovMetaPharma Co., Ltd.

People needed

256

Starts

2018-06-18

Expected to finish

2019-07-15

Last updated by the study team

2019-11-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Study Site 29 — Anniston, Alabama, United States
• Study Site 26 — Birmingham, Alabama, United States
• Study Site 27 — Chula Vista, California, United States
• Study Site 28 — La Mesa, California, United States
• Study Site 10 — Montclair, California, United States
• Study Site 23 — North Hollywood, California, United States
• Study Site 13 — Coral Gables, Florida, United States
• Study Site 19 — DeLand, Florida, United States
• Study Site 14 — Miami, Florida, United States
• Study Site 12 — Miami Beach, Florida, United States
• Study Site 15 — Orlando, Florida, United States
• Study Site 16 — St. Petersburg, Florida, United States
• Study Site 21 — Peachtree Corners, Georgia, United States
• Study Site 17 — Snellville, Georgia, United States
• Study Site 20 — North Dartmouth, Massachusetts, United States
• Study Site 30 — Caro, Michigan, United States
• Study Site 24 — Las Vegas, Nevada, United States
• Study Site 18 — Cleveland, Ohio, United States
• Study Site 22 — San Antonio, Texas, United States
• Study Site 11 — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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