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

NCT03560271 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 256

Last updated 2019-11-18

No results posted yet for this study

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).

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Cyclo-Z

Cyclo (His-Pro) and zinc

OTHER

Placebo

Matching placebo

Sponsors & Collaborators

  • InClin, Inc.

    collaborator UNKNOWN

  • FGK Clinical Research GmbH

    collaborator INDUSTRY

  • NovMetaPharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • MiRa Huyghe · NovMetaPharma Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-18
Primary Completion
2019-06-25
Completion
2019-07-15
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03560271 on ClinicalTrials.gov