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).
Insulin degrading enzyme (IDE) is a zinc-containing enzyme that regulates degradation of internalized insulin and the maintenance of insulin sensitivity. Diabetic animals and humans are zinc deficient due to impaired intestinal zinc absorption and hyperzincuria. If endosomal IDE levels are inadequate, undigested insulin will remain in the cytosol and prevent insulin signal transduction. Cyclo-Z enhances IDE synthesis and stimulates insulin degradation. Although Cyclo (his-pro) (CHP) or zinc alone are somewhat effective in the control of blood glucose metabolism, based on the available literature and previous background studies, it is hypothesized that the combination of CHP and zinc in Cyclo-Z work synergistically to ameliorate insulin resistance in diabetic and obese subjects mainly by stimulating IDE synthesis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
256
Study Site 29
Anniston, Alabama, United States
Study Site 26
Birmingham, Alabama, United States
Change in Glycosylated Hemoglobin (HbA1c) from Baseline at Week 24
Change in HbA1c from Day 1 to Week 24
Time frame: Day 1 to 24 weeks
Change from Baseline in HbA1c over time
Change in HbA1c over 24 weeks
Time frame: Day 1 to 24 weeks
Change from Baseline in fasting plasma glucose (FPG) levels over time
Change in FPG levels over 24 weeks
Time frame: Day 1 to 24 weeks
Change from Baseline in plasma insulin over time
Change in plasma insulin over 24 weeks
Time frame: Day 1 to 24 weeks
Proportion of subjects achieving HbA1c goal of < 7.0% at Week 24
Percent of subjects who achieved HbA1c of \<7% at Week 24
Time frame: Day 1 to 24 weeks
Proportion of subjects achieving HbA1c goal of < 6.5% at Week 24
Percent of subjects who achieved HbA1c of \<6.5% at Week 24
Time frame: Day 1 to 24 weeks
Proportion of subjects with decrease in HbA1c of ≥ 0.5% from Baseline at Week 24
Percent of subjects who achieved HbA1c decrease at Week 24 of ≥ 0.5% from Day 1
Time frame: Day 1 to 24 weeks
Proportion of subjects with decrease in HbA1c of ≥ 1.0% from Baseline at Week 24
Percent of subjects who achieved HbA1c decrease at Week 24 of ≥ 1.0% from Day 1
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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
...and 10 more locations
Time frame: Day 1 to 24 weeks