A Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes

Completed · Phase 2 · Has a placebo group

Conditions studied: Diabetes Mellitus Type 2 in Obese

In brief

This is a double-blind, randomized, placebo-controlled, parallel-group comparison study to evaluate the efficacy and safety of Cyclo-Z for the treatment of subjects with obese type 2 diabetes. The study will consist of 3 phases: * Screening phase (2 weeks) * Treatment phase (12 weeks) * Follow-up phase (2 weeks) Following a 2-week screening period, subjects who meet all inclusion and exclusion criteria will be randomly assigned into one of the following treatment arms: * Dose A: Cyclo-Z containing 23 mg zinc plus 3 mg CHP - 16 subjects * Dose B: Cyclo-Z containing 23 mg zinc plus 9 mg CHP - 16 subjects * Dose C: Cyclo-Z containing 23 mg zinc plus 15 mg CHP - 16 subjects * Dose D: Placebo - 16 subjects The assigned dose will be orally administered to subjects once a day before bedtime for 12 consecutive weeks. After the randomization at Week 0 (Visit 2), subjects will visit their respective trial sites at Weeks 2, 4, 6, 8, 10, 12, and 14 (Visits 3, 4, 5, 6, 7, 8, and 9).

Key facts

Study ID

NCT02784275

Run by

NovMetaPharma Co., Ltd.

People needed

64

Starts

2016-06-09

Expected to finish

2017-05-17

Last updated by the study team

2018-07-12

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 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.
• 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.
• Subjects whose BMI is 30 or above.
• Subjects who can give written informed consent.

You may not qualify if…

• Subjects who have any 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 who have any of the following conditions related to cardiovascular disease:
• 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.
• Uncontrolled hypertension with average systolic blood pressure of > 160 mmHg or diastolic blood pressure > 95 mmHg at Screening and Baseline.
• Pulse rate > 95 beats per minute at Screening and Baseline.
• Stroke or transient ischemic attack in the past 12 months.
• Subjects who have any of the following conditions related to gastrointestinal disease:
• Chronic hepatitis or cirrhosis.
• Episode of alcoholic hepatitis or alcoholic pancreatitis in the past 2 months.
• Inflammatory bowel disease requiring treatment in the past 12 months.
• Significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months.
• Subjects who have serum creatinine > 1.5 mg/dL for male or > 1.4 mg/dL for female.
• Subjects who have chronic obstructive airway disease or asthma requiring daily therapy or home use oxygen.
• Subjects who have hematocrit < 36.0% for male or < 33.0% for female.
• 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 — Los Angeles, California, United States
• Study site — Hialeah, Florida, United States
• Study site — Houston, Texas, United States
• Study site — Tomball, Texas, United States

Full record on ClinicalTrials.gov

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