drugset / Trial / NCT03560271
A Phase 2 Study of Cyclo-Z in Subjects With Type 2 Diabetes
Phase 2
Completed
256 enrolled
NovMetaPharma Co., Ltd.
FGK Clinical Research GmbH · collabInClin, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment
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).
Timeline
- Start
- 2018-06-18
- Primary completion
- 2019-06-25
- Completion
- 2019-07-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclo-Z | Unknown | 6 mg | — |
| Subject | Cyclo-Z | Unknown | 15 mg | — |