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

NCT02784275 | Completed Phase 2 Results

• 1 other identifier: NMP-CYZ-P2-001
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 4

Brief 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

Outcome Measures

Primary Outcomes (2)

• Change of HbA1c Level From Baseline

  Change in HbA1c from Day 1 to Week 12

  12 weeks

• Change of Body Weight From Baseline

  Change in body weight from Day 1 to Week 12

  12 weeks

Secondary Outcomes (7)

• Change of Fasting Plasma Glucose Level From Baseline

  12 weeks

• Proportion of Subjects Achieving HbA1c Goal of <7.0%

  12 weeks

• Proportion of Subjects Achieving HbA1c Goal of <6.5%

  12 weeks

• Change in Waist Circumference From Baseline

  12 weeks

• Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline

  12 weeks

Study Arms (4)

Dose A

EXPERIMENTAL

Cyclo-Z containing 23 mg zinc plus 3 mg CHP

Drug: Cyclo-Z

Dose B

EXPERIMENTAL

Cyclo-Z containing 23 mg zinc plus 9 mg CHP

Drug: Cyclo-Z

Dose C

EXPERIMENTAL

Cyclo-Z containing 23 mg zinc plus 15 mg CHP

Drug: Cyclo-Z

Dose D

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Interventions

Cyclo-Z DRUG

Dose A; Dose B; Dose C

Placebo DRUG

Dose D

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18 or older.
• Subjects diagnosed with type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria.
• Subjects treated with stable doses of insulin and/or other hypoglycemic agent(s) for type 2 diabetes mellitus for at least 2 months prior to randomization.
• Subjects whose fasting blood glucose levels are reasonably stable for at least 2 months prior to randomization and during the 2-week screening period.
• Subjects who have Hemoglobin A1c levels of 7.5 to 10.0 % at Screening.
• Subjects whose BMI is 30 or above.
• Subjects who can give written informed consent.

You may not qualify if:

• Subjects who have any DM-related end-organ damages.
• Subjects who have a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
• Subjects who have any disease likely to limit life span and/or increase risks of interventions such as:
• Carotid B-mode ultrasound test results indicating clinically significant stenosis in the common carotid arteries requiring intervention by angioplasty or resection.
• Cancer treatment in the past 5 years, with the exception of cancers which have been cured, and carry a good prognosis.
• Infectious disease: HIV positivity, active tuberculosis, or pneumonia.
• Subjects who have any of the following conditions related to cardiovascular disease:
• Hospitalization for the treatment of heart disease in the past 12 months.
• New York Heart Association Functional Class \> 2.
• Left Bundle branch block on ECG at Screening.
• Third degree atrioventricular block on ECG at Screening.
• Uncontrolled hypertension with average systolic blood pressure of \> 160 mmHg or diastolic blood pressure \> 95 mmHg at Screening and Baseline.
• Pulse rate \> 95 beats per minute at Screening and Baseline.
• Stroke or transient ischemic attack in the past 12 months.
• Subjects who have any of the following conditions related to gastrointestinal disease:

Sponsors & Collaborators

• NovMetaPharma Co., Ltd.: lead

Study Sites (4)

Unknown Facility

Los Angeles, California, 90036, United States

Location

Unknown Facility

Hialeah, Florida, 33016, United States

Location

Unknown Facility

Houston, Texas, 77095, United States

Location

Unknown Facility

Tomball, Texas, 77375, United States

Location

MeSH Terms

Interventions

Z 008

Results Point of Contact

• Title: Peter Lee
• Organization: NovMetaPharma Co., Ltd

Peter@NovMeta.com

+82 (0)2 538 1893

Study Officials

• Hugh Lee

  KCRN Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 27, 2016
• Study Start: June 9, 2016
• Primary Completion: May 3, 2017
• Study Completion: May 17, 2017
• Last Updated: July 12, 2018
• Results First Posted: June 12, 2018

Record last verified: 2018-07

Locations

US (4)