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

Sponsor
NovMetaPharma Co., Ltd. (Industry)
Overall Status
Completed
CT.gov ID
NCT03560271
Collaborator
InClin, Inc. (Other), FGK Clinical Research GmbH (Industry)
256
Enrollment
20
Locations
3
Arms
12.9
Actual Duration (Months)
12.8
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
Phase 2

Detailed Description

Insulin degrading enzyme (IDE) is a zinc-containing enzyme that regulates degradation of internalized insulin and the maintenance of insulin sensitivity. Diabetic animals and humans are zinc deficient due to impaired intestinal zinc absorption and hyperzincuria. If endosomal IDE levels are inadequate, undigested insulin will remain in the cytosol and prevent insulin signal transduction. Cyclo-Z enhances IDE synthesis and stimulates insulin degradation. Although Cyclo (his-pro) (CHP) or zinc alone are somewhat effective in the control of blood glucose metabolism, based on the available literature and previous background studies, it is hypothesized that the combination of CHP and zinc in Cyclo-Z work synergistically to ameliorate insulin resistance in diabetic and obese subjects mainly by stimulating IDE synthesis.

Study Design

Study Type:
Interventional
Actual Enrollment :
256 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Subject will be assigned to either 6 mg Cyclo-Z, 15 mg Cyclo-Z or placebo for the duration of study treatment.Subject will be assigned to either 6 mg Cyclo-Z, 15 mg Cyclo-Z or placebo for the duration of study treatment.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
The investigator, sponsor, and subject will be blinded to study treatment.
Primary Purpose:
Treatment
Official Title:
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase 2 Study to Evaluate the Efficacy and Safety of Cyclo-Z in Subjects With Type 2 Diabetes
Actual Study Start Date :
Jun 18, 2018
Actual Primary Completion Date :
Jun 25, 2019
Actual Study Completion Date :
Jul 15, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Dose A

Cyclo-Z containing 23 mg zinc plus 6 mg CHP

Drug: Cyclo-Z
Cyclo (His-Pro) and zinc
Other Names:
  • CHP plus zinc

    		•
    Experimental: Dose B

    Cyclo-Z containing 23 mg zinc plus 15 mg CHP

    Drug: Cyclo-Z
    Cyclo (His-Pro) and zinc
    Other Names:
  • CHP plus zinc

    		•
    Placebo Comparator: Dose C

    Placebo

    Other: Placebo
    Matching placebo

    Outcome Measures

    Primary Outcome Measures

    1. Change in Glycosylated Hemoglobin (HbA1c) from Baseline at Week 24 [Day 1 to 24 weeks]

      Change in HbA1c from Day 1 to Week 24

    Secondary Outcome Measures

    1. Change from Baseline in HbA1c over time [Day 1 to 24 weeks]

      Change in HbA1c over 24 weeks

    2. Change from Baseline in fasting plasma glucose (FPG) levels over time [Day 1 to 24 weeks]

      Change in FPG levels over 24 weeks

    3. Change from Baseline in plasma insulin over time [Day 1 to 24 weeks]

      Change in plasma insulin over 24 weeks

    4. Proportion of subjects achieving HbA1c goal of < 7.0% at Week 24 [Day 1 to 24 weeks]

      Percent of subjects who achieved HbA1c of <7% at Week 24

    5. Proportion of subjects achieving HbA1c goal of < 6.5% at Week 24 [Day 1 to 24 weeks]

      Percent of subjects who achieved HbA1c of <6.5% at Week 24

    6. Proportion of subjects with decrease in HbA1c of ≥ 0.5% from Baseline at Week 24 [Day 1 to 24 weeks]

      Percent of subjects who achieved HbA1c decrease at Week 24 of ≥ 0.5% from Day 1

    7. Proportion of subjects with decrease in HbA1c of ≥ 1.0% from Baseline at Week 24 [Day 1 to 24 weeks]

      Percent of subjects who achieved HbA1c decrease at Week 24 of ≥ 1.0% from Day 1

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • 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.

    Exclusion Criteria:

    • 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:

    • Chronic hepatitis or cirrhosis.

    • Episode of alcoholic hepatitis or pancreatitis.

    • Inflammatory bowel disease or irritable bowel syndrome.

    • Significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months.

    • Serum creatinine ≥ 1.5 mg/dL for males or ≥ 1.4 mg/dL for females.

    • Hemoglobin ≤ 12 g/dL for males or ≤ 10 g/dL for females.

    • Subjects who have chronic obstructive airway disease or asthma requiring daily inhaled corticosteroid therapy or home use oxygen.

    • Subjects who have any of the following conditions or behaviors likely to affect the conduct of the study:

    • Weight loss of > 10% in the past 6 months.

    • Unable to walk without assisted device.

    • Major psychiatric disorder which would impede conduct of the research.

    • Excessive alcohol intake (i.e., more than 2 drinks/day).

    • Use of illicit drugs or drugs of abuse.

    • Subjects who take any of the following medications:

    • Psychoactive agents such as monoamine oxidase inhibitors and antidepressants (e.g., lithium, Prozac, Zoloft, Serzone, Paxil, Effexor).

    • Any insulin sensitizers (thiazolidinediones - TZDs) such as Avandia, Actos or Duvie, etc.

    • Subjects with any other clinically significant and/or unexplained abnormalities that, in the opinion of the Investigator, could impact the subject's ability to fully participate in or complete the study.

    • Female subjects who have a positive serum pregnancy test at Screening, plan a pregnancy during study period, or are breast feeding.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Study Site 29 Anniston Alabama United States 36207
    2 Study Site 26 Birmingham Alabama United States 35216
    3 Study Site 27 Chula Vista California United States 91911
    4 Study Site 28 La Mesa California United States 91942
    5 Study Site 10 Montclair California United States 91763
    6 Study Site 23 North Hollywood California United States 91606
    7 Study Site 13 Coral Gables Florida United States 33134
    8 Study Site 19 DeLand Florida United States 32720
    9 Study Site 12 Miami Beach Florida United States 33140
    10 Study Site 14 Miami Florida United States 33155
    11 Study Site 15 Orlando Florida United States 32806
    12 Study Site 16 Saint Petersburg Florida United States 33711
    13 Study Site 21 Peachtree Corners Georgia United States 30071
    14 Study Site 17 Snellville Georgia United States 30078
    15 Study Site 20 North Dartmouth Massachusetts United States 02747
    16 Study Site 30 Caro Michigan United States 48723
    17 Study Site 24 Las Vegas Nevada United States 89106
    18 Study Site 18 Cleveland Ohio United States 44142
    19 Study Site 22 San Antonio Texas United States 78220
    20 Study Site 11 San Antonio Texas United States 78249

    Sponsors and Collaborators

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

    Investigators

    • Study Director: MiRa Huyghe, NovMetaPharma Co., Ltd.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    NovMetaPharma Co., Ltd.
    ClinicalTrials.gov Identifier:
    NCT03560271
    Other Study ID Numbers:
    • NMP-CYZ-P2-002
    First Posted:
    Jun 18, 2018
    Last Update Posted:
    Nov 18, 2019
    Last Verified:
    Nov 1, 2019
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2

    Study Results

    No Results Posted as of Nov 18, 2019