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Diabetes Mellitus Type 2 in ObesePhase 2NCT02784275

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

A Phase 2 study testing Cyclo-Z in people with Diabetes Mellitus Type 2 in Obese, run by NovMetaPharma Co., Ltd. at 4 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 for the treatment of subjects with obese 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 in Obese
What is being tested?
Cyclo-Z
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
64 participants
Where
4 sitesUnited States
Study dates
9 Jun 2016to 17 May 2017
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 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.

Who cannot join

  • 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.
Show all 35Show fewer
  • 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:
  • Chronic hepatitis or cirrhosis.
  • Episode of alcoholic hepatitis or alcoholic pancreatitis in the past 2 months.
  • Inflammatory bowel disease requiring treatment in the past 12 months.
  • Significant abdominal surgery (e.g., gastrectomy, gastric bypass) in the past 2 months.
  • Subjects who have serum creatinine > 1.5 mg/dL for male or > 1.4 mg/dL for female.
  • Subjects who have chronic obstructive airway disease or asthma requiring daily therapy or home use oxygen.
  • Subjects who have hematocrit < 36.0% for male or < 33.0% for female.
  • 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).
  • 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 other medications that may pose harm to the subject.
  • Female subjects who have a positive serum pregnancy test at Screening, plan a pregnancy during study period, or are breast feeding.
  • Female subjects who don't meet any of the following criteria:
  • Surgically sterile (i.e., have had bilateral tubal ligation, hysterectomy, or bilateral oophorectomy) at least 6 months before randomization.
  • Post-menopausal for at least 12 months prior to Screening.
  • If sexually active, they should use oral contraceptives, double barrier contraception (e.g., condom with spermicide), intrauterine device, or other methods approved by the Sponsor.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Houston, Texas, 77095

  • Study site

    Los Angeles, California, 90036

  • Study site

    Tomball, Texas, 77375

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 Patients With Obese Type 2 Diabetes

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:

Read more
  • 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).

Being tested
Cyclo-Z, Placebo

What participants receive

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

  • Cyclo-ZDrug

  • PlaceboDrug

Study groups in NCT02784275
Study groupRoleWhat they receive
Dose AExperimentalCyclo-Z containing 23 mg zinc plus 3 mg CHP
Receives: Drug: Cyclo-Z
Dose BExperimentalCyclo-Z containing 23 mg zinc plus 9 mg CHP
Receives: Drug: Cyclo-Z
Dose CExperimentalCyclo-Z containing 23 mg zinc plus 15 mg CHP
Receives: Drug: Cyclo-Z
Dose DPlacebo comparatorPlacebo
Receives: Drug: Placebo

What is being measured

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

  1. Change of HbA1c Level From Baseline

    Change in HbA1c from Day 1 to Week 12

    Measured: 12 weeks

  2. Change of Body Weight From Baseline

    Change in body weight from Day 1 to Week 12

    Measured: 12 weeks

Secondary outcomes (7)

  1. Change of Fasting Plasma Glucose Level From Baseline

    Change in fasting plasma glucose from Day 1 to Week 12

    Measured: 12 weeks

  2. Proportion of Subjects Achieving HbA1c Goal of <7.0%

    Percent of subjects who achieved HbA1c of <7% at Week 12

    Measured: 12 weeks

  3. Proportion of Subjects Achieving HbA1c Goal of <6.5%

    Percent of subjects who achieved HbA1c of <6% at Week 12

    Measured: 12 weeks

  4. Change in Waist Circumference From Baseline

    Change in waist circumference from Day 1 to Week 12

    Measured: 12 weeks

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

    Change in postprandial (2 hours after dinner) blood glucose levels from Day 1 to Week 12

    Measured: 12 weeks

  6. Change of Oral Glucose Tolerance Test From Baseline

    Change in oral glucose tolerance test results from Day 1 to Week 12

    Measured: 12 weeks

  7. Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline

    Individual 19 domains were calculated as a weighted score (WS) for each domain. Average weighted impact score = summing of WS for each domain/19 domains. Total range possible is -9 to 3, and higher number means improvement in quality of life.

    Measured: 12 weeks

Timeline

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

  1. First posted27 May 2016 (estimated)
  2. Study start9 Jun 2016
  3. Primary completion3 May 2017
  4. Study completion17 May 2017

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
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
64 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02784275
Sponsor's protocol ID
NMP-CYZ-P2-001
Status last verified
Jul 2018
First submitted
24 May 2016
Last updated
12 Jul 2018
Data monitoring committee
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 in Obese, run by NovMetaPharma Co., Ltd. at 4 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 7 inclusion and 35 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 12 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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?

Yes. Results are posted in the registry (first posted 12 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 of HbA1c Level From Baseline (time frame: 12 weeks). The study lists 2 primary outcomes in all. 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 NCT02784275.

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 12 Jul 2018.

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