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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
64
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Hialeah, Florida, United States
Unnamed facility
Houston, Texas, United States
Unnamed facility
Tomball, Texas, United States
Change of HbA1c Level From Baseline
Change in HbA1c from Day 1 to Week 12
Time frame: 12 weeks
Change of Body Weight From Baseline
Change in body weight from Day 1 to Week 12
Time frame: 12 weeks
Change of Fasting Plasma Glucose Level From Baseline
Change in fasting plasma glucose from Day 1 to Week 12
Time frame: 12 weeks
Proportion of Subjects Achieving HbA1c Goal of <7.0%
Percent of subjects who achieved HbA1c of \<7% at Week 12
Time frame: 12 weeks
Proportion of Subjects Achieving HbA1c Goal of <6.5%
Percent of subjects who achieved HbA1c of \<6% at Week 12
Time frame: 12 weeks
Change in Waist Circumference From Baseline
Change in waist circumference from Day 1 to Week 12
Time frame: 12 weeks
Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline
Change in postprandial (2 hours after dinner) blood glucose levels from Day 1 to Week 12
Time frame: 12 weeks
Change of Oral Glucose Tolerance Test From Baseline
Change in oral glucose tolerance test results from Day 1 to Week 12
Time frame: 12 weeks
Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline
Individual 19 domains were calculated as a weighted score (WS) for each domain. Average weighted impact score = summing of WS for each domain/19 domains. Total range possible is -9 to 3, and higher number means improvement in quality of life.
Time frame: 12 weeks
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