Clinical trial NCT02784275: A Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus Type 2 in Obese
Lead sponsor: NovMetaPharma Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

1. Males or females aged 18 or older.
2. Subjects diagnosed with type 2 diabetes mellitus according to the American Diabetes Association (ADA) criteria.
3. 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.
4. Subjects whose fasting blood glucose levels are reasonably stable for at least 2 months prior to randomization and during the 2-week screening period.
5. Subjects who have Hemoglobin A1c levels of 7.5 to 10.0 % at Screening.
6. Subjects whose BMI is 30 or above.
7. Subjects who can give written informed consent.

Exclusion Criteria:

1. Subjects who have any DM-related end-organ damages.
2. Subjects who have a history of diabetic ketoacidosis or hyperosmolar non-ketotic coma.
3. 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.
4. 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.
5. 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.
6. Subjects who have serum creatinine \> 1.5 mg/dL for male or \> 1.4 mg/dL for female.
7. Subjects who have chronic obstructive airway disease or asthma requiring daily therapy or home use oxygen.
8. Subjects who have hematocrit \< 36.0% for male or \< 33.0% for female.
9. 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).
10. 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.
11. Female subjects who have a positive serum pregnancy test at Screening, plan a pregnancy during study period, or are breast feeding.
12. 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.

Primary outcomes:
measure: Change of HbA1c Level From Baseline
timeFrame: 12 weeks
measure: Change of Body Weight From Baseline
timeFrame: 12 weeks
Secondary outcomes:
measure: Change of Fasting Plasma Glucose Level From Baseline
timeFrame: 12 weeks
measure: Proportion of Subjects Achieving HbA1c Goal of <7.0%
timeFrame: 12 weeks
measure: Proportion of Subjects Achieving HbA1c Goal of <6.5%
timeFrame: 12 weeks
measure: Change in Waist Circumference From Baseline
timeFrame: 12 weeks
measure: Change of Postprandial (2 Hours After Dinner) Blood Glucose Level From Baseline
timeFrame: 12 weeks
measure: Change of Oral Glucose Tolerance Test From Baseline
timeFrame: 12 weeks
measure: Change of Score in Audit of Diabetes-Dependent Quality of Life Questionnaire From Baseline
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
state: California
city: Hialeah
country: United States
state: Florida
city: Houston
country: United States
state: Texas
city: Tomball
country: United States
state: Texas
Study officials:
affiliation: KCRN Research
name: Hugh Lee
role: STUDY_DIRECTOR
References: