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Clinical Trial Details

Trial ID: L7144
Source ID: NCT02435277
Associated Drug: Low Metformin
Title: An Extension Protocol to Evaluate Dose Comparisons of Leucine-Metformin Combinations in Type 2 Diabetic Patients
Acronym:
Status: COMPLETED
Study Results: YES
Results: https://ClinicalTrials.gov/show/NCT02435277/results
Conditions: Type 2 Diabetes Mellitus
Interventions: DRUG: Low Metformin|DRUG: Mid Metformin|DRUG: High Metformin|DRUG: Metformin
Outcome Measures: Primary: Change in HbA1c Levels in Patient Receiving the Various Doses of Leucine and Metformin Combinations, Change in HbA1c from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E) in subjects receiving various fixed-dose combinations of leucine and metformin compared to standard metformin monotherapy., Baseline and 12 weeks | Secondary: Change in Fasting Plasma Glucose, Change in fasting plasma glucose from Baseline (Day 1/Visit 1) of Study NS-0100-01 to Week 12 (Day 84/Visit 3E). Based on the pre-specified mixed model inferential statistical analysis, there was an apparent dose-dependent relationship for the mean decrease from baseline in fasting plasma glucose for the fixed dose leucine amd metformin combination treatments A, B and C., Baseline and 12 weeks
Sponsor/Collaborators: Sponsor: NuSirt Biopharma
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE2
Enrollment: 50
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2014-10
Completion Date: 2016-01
Results First Posted: 2017-12-18
Last Update Posted: 2018-01-17
Locations: Catalina Research Institute, Chino, California, 91710, United States|Palm Beach Research, Palm Beach, Florida, 33409, United States|Meridien Research, Tampa, Florida, 33606, United States|River Birch Research Alliance, Blue Ridge, Georgia, 3051313, United States|Meridian Research, Savannah, Georgia, 31406, United States|Streling Research Group, Cincinnati, Ohio, 45219, United States|Medical Research South, Charleston, South Carolina, 29407, United States|Meharry Medical College, Nashville, Tennessee, 37208, United States|Vanderbilt University Medical Center, Diabetes, Endocrinology, and Metabolism, Nashville, Tennessee, 37232, United States
URL: https://clinicaltrials.gov/show/NCT02435277

Drug ID Drug Name Type DrugBank ID Targets Category Latest Progress
D089 Metformin small molecule DB00331 Details