| Trial ID: | L6462 |
| Source ID: | NCT02151461
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| Associated Drug: |
Low Metformin
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| Title: |
Dose Comparisons of Leucine-Metformin Combinations on Blood Glucose Levels In Type 2 Diabetic Patients
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02151461/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Low Metformin|DRUG: Metformin|DRUG: Mid Metformin|DRUG: High Metformin
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| Outcome Measures: |
Primary: Change From Baseline to Day 28 in Absolute Plasma Glucose Area Under the Curve (AUC) 0-3hr, The primary endpoint for NS 0100 01 was the absolute plasma glucose AUC (0-3 hr) change from Day 1 to Day 28., 0, 15min, 30min, 45min, 1hr, 1.5hrs, 2hrs, 2.5hrs and 3 hrs | Secondary: Change From Baseline to Day 28 in Incremental Plasma Glucose Area Under the Curve (AUC), The baseline incremental (baseline-subtracted) glucose AUC0-3h was evaluated for treatment differences at baseline., Baseline, Day 28|Change in Fasting Plasma Glucose, Change in fasting plasma glucose for the fixed dose leucine and metformin combination treatments A, B and C was evaluated., Baseline, Day 28|Change in Hemoglobin A1c (HbA1c), Changes in HbA1c which is a marker of long-term glucose control was assessed., Baseline, Day 28|Change in Homeostasis Model Assessment-estimated Insulin Resistance (HOMA-IR), Effect on insulin sensitivity across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment., Baseline, Day 28|Change In 7-Point Glucose Profiles, The meal induced glucose change in pre-meal and post-meal glucose were measured 7 times during the day. Subjects self-monitored blood glucose (preprandial and postprandial) concentrations at least 7 times, including before and 1 to 2 hours after breakfast, lunch, dinner, and snacks). For each study day, the pre-meal values from the 7 point test for each subject were averaged to generate a single pre-meal glucose value. Similarly, for each study day the post-meal values from the 7-point test for each subject were averaged to generate a single post-meal glucose value. The average change from baseline (i.e., \[(Mean Pre/Post-meal value at Day 28 - Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 21- Mean Pre/Post-meal value at Baseline) + (Mean Pre/Post-meal value at Day 7- Mean Pre/Post-meal value at Baseline)\]/ 3) over multiple time points listed in Time Frame. The mean pre-meal and post-meal values for baseline, day7, day 21 and day28 were used for comparison., Baseline, Day 7, Day 21, Day 28|Plasma Insulin Absolute and Incremental Meal Tolerance Test Area Under the Curve (AUC) 0-2hr, Change in meal tolerance test insulin area under the curve (0-2 hr) from Day 1 to Day 28 for fixed-dose leucine and metformin combination treatments., Baseline,Day 28|Change From Baseline to Day 28 in Fasting Plasma Insulin Concentration, Effect on fasting plasma insulin concentrations across fixed-dose leucine and metformin combination treatments or the standard metformin reference treatment was evaluated., Baseline, Day 28
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| Sponsor/Collaborators: |
Sponsor: NuSirt Biopharma
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
96
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2014-07
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| Completion Date: |
2016-01
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| Results First Posted: |
2018-02-05
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| Last Update Posted: |
2018-02-27
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| 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, 30513, 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
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| URL: |
https://clinicaltrials.gov/show/NCT02151461
|
