A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes
Overview
- Phase
- Phase 2
- Intervention
- Cyclo-Z
- Conditions
- Diabetes Mellitus Type 2 in Obese
- Sponsor
- NovMetaPharma Co., Ltd.
- Enrollment
- 64
- Primary Endpoint
- Change of HbA1c Level From Baseline
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
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).
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 \>
- •Left Bundle branch block on ECG at Screening.
Arms & Interventions
Dose A
Cyclo-Z containing 23 mg zinc plus 3 mg CHP
Intervention: Cyclo-Z
Dose B
Cyclo-Z containing 23 mg zinc plus 9 mg CHP
Intervention: Cyclo-Z
Dose C
Cyclo-Z containing 23 mg zinc plus 15 mg CHP
Intervention: Cyclo-Z
Dose D
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Change of HbA1c Level From Baseline
Time Frame: 12 weeks
Change in HbA1c from Day 1 to Week 12
Change of Body Weight From Baseline
Time Frame: 12 weeks
Change in body weight from Day 1 to Week 12
Secondary Outcomes
- Change of Fasting Plasma Glucose Level From Baseline(12 weeks)
- Proportion of Subjects Achieving HbA1c Goal of <7.0%(12 weeks)
- Proportion of Subjects Achieving HbA1c Goal of <6.5%(12 weeks)
- Change in Waist Circumference From Baseline(12 weeks)
- Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline(12 weeks)
- Change of Oral Glucose Tolerance Test From Baseline(12 weeks)
- Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline(12 weeks)