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Diabetes Mellitus, Type 2Phase 2NCT03560271

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

A Phase 2 study testing Cyclo-Z in people with Diabetes Mellitus, Type 2, run by NovMetaPharma Co., Ltd. at 20 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Diabetes Mellitus, Type 2
What is being tested?
Cyclo-Z
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
256 participants
Where
20 sitesUnited States
Study dates
18 Jun 2018to 15 Jul 2019
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

United States20 sites

  • Study Site 29

    Anniston, Alabama, 36207

  • Study Site 26

    Birmingham, Alabama, 35216

  • Study Site 30

    Caro, Michigan, 48723

  • Study Site 27

    Chula Vista, California, 91911

  • Study Site 18

    Cleveland, Ohio, 44142

  • Study Site 13

    Coral Gables, Florida, 33134

  • Study Site 19

    DeLand, Florida, 32720

  • Study Site 28

    La Mesa, California, 91942

  • Study Site 24

    Las Vegas, Nevada, 89106

  • Study Site 14

    Miami, Florida, 33155

  • Study Site 12

    Miami Beach, Florida, 33140

  • Study Site 10

    Montclair, California, 91763

  • Study Site 20

    North Dartmouth, Massachusetts, 02747

  • Study Site 23

    North Hollywood, California, 91606

  • Study Site 15

    Orlando, Florida, 32806

  • Study Site 21

    Peachtree Corners, Georgia, 30071

  • Study Site 22

    San Antonio, Texas, 78220

  • Study Site 11

    San Antonio, Texas, 78249

  • Study Site 17

    Snellville, Georgia, 30078

  • Study Site 16

    St. Petersburg, Florida, 33711

Other trials in United States

About this study

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

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).

Read the 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.

Being tested
Cyclo-Z, Placebo
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cyclo-ZDrug

    Also called CHP plus zinc

    Cyclo (His-Pro) and zinc

  • PlaceboOther

    Matching placebo

Study groups in NCT03560271
Study groupRoleWhat they receive
Dose AExperimentalCyclo-Z containing 23 mg zinc plus 6 mg CHP
Receives: Drug: Cyclo-Z
Dose BExperimentalCyclo-Z containing 23 mg zinc plus 15 mg CHP
Receives: Drug: Cyclo-Z
Dose CPlacebo comparatorPlacebo
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Change in HbA1c from Day 1 to Week 24

    Measured: Day 1 to 24 weeks

Secondary outcomes (7)

  1. Change from Baseline in HbA1c over time

    Change in HbA1c over 24 weeks

    Measured: Day 1 to 24 weeks

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

    Change in FPG levels over 24 weeks

    Measured: Day 1 to 24 weeks

  3. Change from Baseline in plasma insulin over time

    Change in plasma insulin over 24 weeks

    Measured: Day 1 to 24 weeks

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

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

    Measured: Day 1 to 24 weeks

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

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

    Measured: Day 1 to 24 weeks

  6. Proportion of subjects with decrease in HbA1c of ≥ 0.5% from Baseline at Week 24

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

    Measured: Day 1 to 24 weeks

  7. Proportion of subjects with decrease in HbA1c of ≥ 1.0% from Baseline at Week 24

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

    Measured: Day 1 to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2018
  2. Study start18 Jun 2018
  3. Primary completion25 Jun 2019
  4. Study completion15 Jul 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Subject will be assigned to either 6 mg Cyclo-Z, 15 mg Cyclo-Z or placebo for the duration of study treatment.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
256 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03560271
Sponsor's protocol ID
NMP-CYZ-P2-002
Status last verified
Nov 2019
First submitted
6 Jun 2018
Last updated
18 Nov 2019
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Cyclo-Z in people with Diabetes Mellitus, Type 2, run by NovMetaPharma Co., Ltd. at 20 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Glycosylated Hemoglobin (HbA1c) from Baseline at Week 24 (time frame: Day 1 to 24 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03560271.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2019.

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