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

NCT03560271 | Completed Phase 2 FDA Drug

• 1 other identifier: NMP-CYZ-P2-002
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 20

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Glycosylated Hemoglobin (HbA1c) from Baseline at Week 24

  Change in HbA1c from Day 1 to Week 24

  Day 1 to 24 weeks

Secondary Outcomes (7)

• Change from Baseline in HbA1c over time

  Day 1 to 24 weeks

• Change from Baseline in fasting plasma glucose (FPG) levels over time

  Day 1 to 24 weeks

• Change from Baseline in plasma insulin over time

  Day 1 to 24 weeks

• Proportion of subjects achieving HbA1c goal of < 7.0% at Week 24

  Day 1 to 24 weeks

• Proportion of subjects achieving HbA1c goal of < 6.5% at Week 24

  Day 1 to 24 weeks

Study Arms (3)

Dose A

EXPERIMENTAL

Cyclo-Z containing 23 mg zinc plus 6 mg CHP

Drug: Cyclo-Z

Dose B

EXPERIMENTAL

Cyclo-Z containing 23 mg zinc plus 15 mg CHP

Drug: Cyclo-Z

Dose C

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Cyclo-Z DRUG

Cyclo (His-Pro) and zinc

Also known as: CHP plus zinc

Dose A; Dose B

Placebo OTHER

Matching placebo

Dose C

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 (DM) 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 and who agree to stay on stable doses of anti-diabetes agents during the study.
• 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 and a fasting plasma glucose less than 310 mg/dL.
• Subjects who can give written informed consent.
• Subjects who are willing and able to monitor their blood glucose concentrations with a home glucose monitor (before breakfast and 2 hours after dinner).
• Female subjects must be either:
• Surgically sterile (i.e., have had bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 months before randomization, or
• Post-menopausal for at least 12 months prior to Screening, or
• If of childbearing potential and sexually active, must agree to use adequate contraception from Screening to completion of the study.

You may not qualify if:

• Subjects who have any significant 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 with evidence of clinically significant cardiovascular or cerebrovascular disease, including (but not limited to):
• 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.
• Stroke or transient ischemic attack in the past 12 months.
• Subjects with uncontrolled hypertension with average systolic blood pressure of ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg at Screening and Baseline.
• Subjects with pulse rate ≥ 95 beats per minute at Screening and Baseline.
• Subjects who have or had any of the following conditions related to gastrointestinal disease:

Sponsors & Collaborators

• NovMetaPharma Co., Ltd.: lead
• InClin, Inc.: collaborator
• FGK Clinical Research GmbH: collaborator

Study Sites (20)

Study Site 29

Anniston, Alabama, 36207, United States

Location

Study Site 26

Birmingham, Alabama, 35216, United States

Location

Study Site 27

Chula Vista, California, 91911, United States

Location

Study Site 28

La Mesa, California, 91942, United States

Location

Study Site 10

Montclair, California, 91763, United States

Location

Study Site 23

North Hollywood, California, 91606, United States

Location

Study Site 13

Coral Gables, Florida, 33134, United States

Location

Study Site 19

DeLand, Florida, 32720, United States

Location

Study Site 14

Miami, Florida, 33155, United States

Location

Study Site 12

Miami Beach, Florida, 33140, United States

Location

Study Site 15

Orlando, Florida, 32806, United States

Location

Study Site 16

St. Petersburg, Florida, 33711, United States

Location

Study Site 21

Peachtree Corners, Georgia, 30071, United States

Location

Study Site 17

Snellville, Georgia, 30078, United States

Location

Study Site 20

North Dartmouth, Massachusetts, 02747, United States

Location

Study Site 30

Caro, Michigan, 48723, United States

Location

Study Site 24

Las Vegas, Nevada, 89106, United States

Location

Study Site 18

Cleveland, Ohio, 44142, United States

Location

Study Site 22

San Antonio, Texas, 78220, United States

Location

Study Site 11

San Antonio, Texas, 78249, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Z 008; somatostatin, cyclic hexapeptide(Phe-Phe-Trp-Lys-Thr-Phe)-; Zinc

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Metals, Heavy; Elements; Inorganic Chemicals; Transition Elements; Metals

Study Officials

• MiRa Huyghe

  NovMetaPharma Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigator, sponsor, and subject will be blinded to study treatment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subject will be assigned to either 6 mg Cyclo-Z, 15 mg Cyclo-Z or placebo for the duration of study treatment.

Study Record Dates

• First Submitted: June 6, 2018
• First Posted: June 18, 2018
• Study Start: June 18, 2018
• Primary Completion: June 25, 2019
• Study Completion: July 15, 2019
• Last Updated: November 18, 2019

Record last verified: 2019-11

Locations

US (20)