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Clinical Trial Details

Trial ID: L6515
Source ID: NCT03560271
Associated Drug: Cyclo-Z
Title: A Phase 2 Study of Cyclo-Z in Subjects With Type 2 Diabetes
Acronym:
Status: COMPLETED
Study Results: NO
Results:
Conditions: Diabetes Mellitus, Type 2
Interventions: DRUG: Cyclo-Z|OTHER: Placebo
Outcome Measures: Primary: Change in Glycosylated Hemoglobin (HbA1c) from Baseline at Week 24, Change in HbA1c from Day 1 to Week 24, Day 1 to 24 weeks | Secondary: Change from Baseline in HbA1c over time, Change in HbA1c over 24 weeks, Day 1 to 24 weeks|Change from Baseline in fasting plasma glucose (FPG) levels over time, Change in FPG levels over 24 weeks, Day 1 to 24 weeks|Change from Baseline in plasma insulin over time, Change in plasma insulin over 24 weeks, Day 1 to 24 weeks|Proportion of subjects achieving HbA1c goal of < 7.0% at Week 24, Percent of subjects who achieved HbA1c of \<7% at Week 24, Day 1 to 24 weeks|Proportion of subjects achieving HbA1c goal of < 6.5% at Week 24, Percent of subjects who achieved HbA1c of \<6.5% at Week 24, Day 1 to 24 weeks|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, Day 1 to 24 weeks|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, Day 1 to 24 weeks
Sponsor/Collaborators: Sponsor: NovMetaPharma Co., Ltd. | Collaborators: InClin, Inc.|FGK Clinical Research GmbH
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 256
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2018-06-18
Completion Date: 2019-07-15
Results First Posted:
Last Update Posted: 2019-11-18
Locations: Study Site 29, Anniston, Alabama, 36207, United States|Study Site 26, Birmingham, Alabama, 35216, United States|Study Site 27, Chula Vista, California, 91911, United States|Study Site 28, La Mesa, California, 91942, United States|Study Site 10, Montclair, California, 91763, United States|Study Site 23, North Hollywood, California, 91606, United States|Study Site 13, Coral Gables, Florida, 33134, United States|Study Site 19, DeLand, Florida, 32720, United States|Study Site 12, Miami Beach, Florida, 33140, United States|Study Site 14, Miami, Florida, 33155, United States|Study Site 15, Orlando, Florida, 32806, United States|Study Site 16, Saint Petersburg, Florida, 33711, United States|Study Site 21, Peachtree Corners, Georgia, 30071, United States|Study Site 17, Snellville, Georgia, 30078, United States|Study Site 20, North Dartmouth, Massachusetts, 02747, United States|Study Site 30, Caro, Michigan, 48723, United States|Study Site 24, Las Vegas, Nevada, 89106, United States|Study Site 18, Cleveland, Ohio, 44142, United States|Study Site 22, San Antonio, Texas, 78220, United States|Study Site 11, San Antonio, Texas, 78249, United States
URL: https://clinicaltrials.gov/show/NCT03560271

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress