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

NCT02784275 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-07-12

Study results available
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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

DRUG

Cyclo-Z

DRUG

Placebo

Sponsors & Collaborators

  • NovMetaPharma Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hugh Lee · KCRN Research

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-09
Primary Completion
2017-05-03
Completion
2017-05-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02784275 on ClinicalTrials.gov