| Trial ID: | L5505 |
| Source ID: | NCT02784275
|
| Associated Drug: |
Cyclo-Z
|
| Title: |
A Study to Evaluate the Efficacy and Safety of Cyclo-Z in Patients With Obese Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02784275/results
|
| Conditions: |
Diabetes Mellitus Type 2 in Obese
|
| Interventions: |
DRUG: Cyclo-Z|DRUG: Placebo
|
| Outcome Measures: |
Primary: 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 | Secondary: 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, 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
|
| Sponsor/Collaborators: |
Sponsor: NovMetaPharma Co., Ltd.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
64
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2016-06-09
|
| Completion Date: |
2017-05-17
|
| Results First Posted: |
2018-06-12
|
| Last Update Posted: |
2018-07-12
|
| Locations: |
Los Angeles, California, 90036, United States|Hialeah, Florida, 33016, United States|Houston, Texas, 77095, United States|Tomball, Texas, 77375, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02784275
|
