NCT02784275

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 64 (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 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).

Conditions

• Diabetes Mellitus Type 2 in Obese

Interventions

Type	Name	Description
DRUG	Cyclo-Z
DRUG	Placebo

Timeline

• Start date: 2016-06-09
• Primary completion: 2017-05-03
• Completion: 2017-05-17
• First posted: 2016-05-27
• Last updated: 2018-07-12
• Results posted: 2018-06-12

Locations

4 sites across 1 country: United States