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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:
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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose A | Experimental | Cyclo-Z containing 23 mg zinc plus 3 mg CHP |
|
| Dose B | Experimental | Cyclo-Z containing 23 mg zinc plus 9 mg CHP |
|
| Dose C | Experimental | Cyclo-Z containing 23 mg zinc plus 15 mg CHP |
|
| Dose D | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cyclo-Z | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change of HbA1c Level From Baseline | Change in HbA1c from Day 1 to Week 12 | 12 weeks |
| Change of Body Weight From Baseline | Change in body weight from Day 1 to Week 12 | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change of Fasting Plasma Glucose Level From Baseline | Change in fasting plasma glucose from Day 1 to Week 12 | 12 weeks |
| Proportion of Subjects Achieving HbA1c Goal of <7.0% | Percent of subjects who achieved HbA1c of <7% at Week 12 |
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Inclusion Criteria:
Exclusion Criteria:
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:
Subjects who have any of the following conditions related to cardiovascular disease:
Subjects who have any of the following conditions related to gastrointestinal disease:
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:
Subjects who take any of the following medications:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Hugh Lee | KCRN Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Los Angeles | California | 90036 | United States | |||
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| ID | Title | Description |
|---|---|---|
| FG000 | 3 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 3 mg CHP Cyclo-Z |
| FG001 | 9 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 9 mg CHP Cyclo-Z |
| FG002 | 15 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 15 mg CHP Cyclo-Z |
| FG003 | Placebo | Placebo Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 3 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 3 mg CHP Cyclo-Z |
| BG001 | 9 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 9 mg CHP Cyclo-Z |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change of HbA1c Level From Baseline | Change in HbA1c from Day 1 to Week 12 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However only 54 subjects had Week 12 values (12, 15, 14, and 13 subjects, respectively). | Posted | Mean | Standard Deviation | (%) | 12 weeks |
|
14 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 3 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 3 mg CHP Cyclo-Z |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Angina pectoris | Cardiac disorders | MedDRA (20.0) | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blood glucose increased | Investigations | MedDRA (20.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Peter Lee | NovMetaPharma Co., Ltd | +82 (0)2 538 1893 | Peter@NovMeta.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 16, 2017 | Feb 21, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 9, 2016 | Feb 21, 2018 | Prot_001.pdf |
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| ID | Term |
|---|---|
| C087823 | Z 008 |
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|
| 12 weeks |
| Proportion of Subjects Achieving HbA1c Goal of <6.5% | Percent of subjects who achieved HbA1c of <6% at Week 12 | 12 weeks |
| Change in Waist Circumference From Baseline | Change in waist circumference from Day 1 to Week 12 | 12 weeks |
| 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 | 12 weeks |
| Change of Oral Glucose Tolerance Test From Baseline | Change in oral glucose tolerance test results from Day 1 to Week 12 | 12 weeks |
| 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. | 12 weeks |
| Hialeah |
| Florida |
| 33016 |
| United States |
| Houston | Texas | 77095 | United States |
| Tomball | Texas | 77375 | United States |
| BG002 | 15 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 15 mg CHP Cyclo-Z |
| BG003 | Placebo | Placebo Placebo |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Age of the subjects at the time of study entry. | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Cyclo-Z containing 23 mg zinc plus 15 mg CHP Cyclo-Z |
| OG003 | Placebo | Placebo Placebo |
|
|
| Primary | Change of Body Weight From Baseline | Change in body weight from Day 1 to Week 12 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values for weight (12, 15, 14, and 13, respectively). | Posted | Mean | Standard Deviation | kg | 12 weeks |
|
|
|
| Secondary | Change of Fasting Plasma Glucose Level From Baseline | Change in fasting plasma glucose from Day 1 to Week 12 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively). | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Proportion of Subjects Achieving HbA1c Goal of <7.0% | Percent of subjects who achieved HbA1c of <7% at Week 12 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13 respectively). | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Proportion of Subjects Achieving HbA1c Goal of <6.5% | Percent of subjects who achieved HbA1c of <6% at Week 12 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 54 subjects had Week 12 values (12, 15, 14, and 13, respectively). | Posted | Count of Participants | Participants | 12 weeks |
|
|
|
| Secondary | Change in Waist Circumference From Baseline | Change in waist circumference from Day 1 to Week 12 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 values (12, 14, 14, and 13 respectively). | Posted | Mean | Standard Deviation | cm | 12 weeks |
|
|
|
| Secondary | 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 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 postprandial glucose values (11, 14, 14, and 12, respectively). | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | Change of Oral Glucose Tolerance Test From Baseline | Change in oral glucose tolerance test results from Day 1 to Week 12 | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 53 subjects had Week 12 oral glucose tolerance test results (12, 15, 14, and 12, respectively). | Posted | Mean | Standard Deviation | mg/dL | 12 weeks |
|
|
|
| Secondary | 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. | Efficacy Analysis Set (N=61) was used for the efficacy analysis. However, only 51 subjects had Week 12 ADDQoL results (9, 15, 14, and 13, respectively). | Posted | Mean | Standard Deviation | Score on a scale | 12 weeks |
|
|
|
| 0 |
| 15 |
| 1 |
| 15 |
| 5 |
| 15 |
| EG001 | 9 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 9 mg CHP Cyclo-Z | 0 | 16 | 0 | 16 | 7 | 16 |
| EG002 | 15 mg CHP Plus 23 mg Zinc | Cyclo-Z containing 23 mg zinc plus 15 mg CHP Cyclo-Z | 0 | 16 | 0 | 16 | 13 | 16 |
| EG003 | Placebo | Placebo Placebo | 0 | 14 | 0 | 14 | 7 | 14 |
| Blood insulin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Glycosylated haemoglobin increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Oedema | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA (20.0) | Systematic Assessment |
|
| Blood zinc increased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Cardiac murmur | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Glucose urine present | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Viral upper respiratory tract infection | Infections and infestations | MedDRA (20.0) | Systematic Assessment |
|
| Polyuria | Renal and urinary disorders | MedDRA (20.0) | Systematic Assessment |
|
| Haemotocrit decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Haemoglobin decreased | Investigations | MedDRA (20.0) | Systematic Assessment |
|
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (20.0) | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA (20.0) | Systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA (20.0) | Systematic Assessment |
|
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