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Clinical Trial Details

Trial ID: L3232
Source ID: NCT03279263
Associated Drug: Mlr-1023
Title: An Add-on Study of MLR-1023 in Adults With Uncontrolled Type 2 Diabetes on Metformin Therapy
Acronym:
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: MLR-1023|OTHER: Placebo
Outcome Measures: Primary: Changes in HbA1c between active treatment groups and placebo at Week 12, Change in HbA1c from Baseline to Week 12, 12 Weeks | Secondary: HbA1c of < 7.0% at Week 12, Proportion of Subjects with HbA1c of \< 7.0% at Week 12, 12 Weeks|HbA1c of < 6.5% at Week 12, Proportion of Subjects with HbA1c of \< 6.5% at Week 12, 12 Weeks|Changes in Fasting Plasma Glucose (FPG) from Baseline to Week 12 between active treatment groups and placebo, Changes in FPG from Baseline to Week 12, 12 Weeks|Changes in fasting insulin, insulin sensitivities (HOMA IR), Changes in fasting insulin, insulin sensitivities (HOMA IR) from Baseline to Week 12, 12 Weeks|Changes in lipid profile (low density lipoprotein cholesterol [LDL-C], high density lipoprotein cholesterol [HDL-C], triglycerides), Changes in lipid profile (low density lipoprotein cholesterol \[LDL-C\], high density lipoprotein cholesterol \[HDL-C\], triglycerides) from Baseline to Week 12, 12 Weeks|Changes in Body Weight, Changes in Body Weight from Baseline to Week 12, 12 Weeks
Sponsor/Collaborators: Sponsor: Melior Pharmaceuticals | Collaborators: Bukwang Pharmaceutical, Co., Ltd.
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 400
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2017-09-01
Completion Date: 2019-09
Results First Posted:
Last Update Posted: 2019-01-09
Locations: National Research Institute, Los Angeles, California, 90057, United States
URL: https://clinicaltrials.gov/show/NCT03279263