NCT03560271

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

A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Cyclo-Z in Subjects With Type 2 Diabetes

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (actual)
• Sponsor: NovMetaPharma Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Cyclo-Z	Cyclo (His-Pro) and zinc
OTHER	Placebo	Matching placebo

Timeline

• Start date: 2018-06-18
• Primary completion: 2019-06-25
• Completion: 2019-07-15
• First posted: 2018-06-18
• Last updated: 2019-11-18

Locations

20 sites across 1 country: United States

Regulatory

• FDA-regulated drug study