| Trial ID: | L3714 |
| Source ID: | NCT02597101
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| Associated Drug: |
Metformin
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| Title: |
Anti-Inflammatory Small Drug Adjunctive Therapy for Type 2 Diabetes
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT02597101/results
|
| Conditions: |
Type 2 Diabetes Mellitus|Insulin Resistance
|
| Interventions: |
DRUG: Metformin|DRUG: saxagliptin|DRUG: AZD9668|DRUG: placebo
|
| Outcome Measures: |
Primary: Insulin Sensitivity at 6 Months From Baseline, The primary outcome measure is the insulin sensitivity at 6 months from baseline, assessed by the hyperinsulinemic-euglycemic clamp method. This is calculated as the M/LBM. M/LBM = whole-body insulin sensitivity adjusted for lean body mass. M/LBM is calculated as the steady-state glucose disposal (in mL) per kilogram lean body mass divided by steady-state insulin concentrations (micro IU/mL)., 6 months | Secondary: Severity of All Adverse Events Including Hypoglycemia, Severity of all adverse events including hypoglycemia based on the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 severity grade score (0-4). Higher scores indicate a worse severity., 12 months|Severity of Known AEs of AZD9668, Attribution score of AE to known AEs of AZD9668 in terms of an atribution scale of 0-4. The scale is defined as: Score 0=Unrelated; Score 1=The AE is unlikely related; Score 2=The AE has a reasonable possibility to be related; Score 3=The AE is likely related; Score 4=The AE is clearly related, 12 months|Severity of Known AEs of Saxagliptin, Attribution score of AE to known AEs of saxagliptin in terms of an atribution scale of 0-4. The scale is defined as: Score 0=Unrelated; Score 1=The AE is unlikely related; Score 2=The AE has a reasonable possibility to be related; Score 3=The AE is likely related; Score 4=The AE is clearly related, 12 months|Severity of Known AEs of Metformin, Attribution score of AE to known AEs of metformin in terms of an atribution scale of 0-4. The scale is defined as: Score 0=Unrelated; Score 1=The AE is unlikely related; Score 2=The AE has a reasonable possibility to be related; Score 3=The AE is likely related; Score 4=The AE is clearly related, 12 months|Change in Glycated HbA1c Levels Compared to Baseline, Difference in the value of HbA1c study end (12 months) compared to baseline value (time 0), 12 months|Change in OGTT From Baseline, The difference of the calculated area under the curve of the 2 hour OGTT test (AUC is the value of the area under the glucose concentration time curve) at 12 months minus the AUC at baseline (time zero). This AUC is calculated as the concentration of glucose versus time curve and the reporting units are mcg\*dL/hour. The trapezoid rule was applied to the curve to obtain the AUC., 12 months|Change in OGTT-derived Insulinogenic Index Using C-peptide, The change from baseline at 12 months where the insulinogenic index = ratio of fasting C-peptide concentration (ng/mL)/fasting glucose (ng/mL) at the time of the OGTT test., 12 months|Change From Baseline in the Serum Levels of Inflammatory Markers, Serum levels refers to the concentration in serum of each of the analytes in the multi-analyte assay (Luminex) in terms of pg/mL depending on the analyte measured. We are reporting the difference in these values between 12 months and baseline., 12 months
|
| Sponsor/Collaborators: |
Sponsor: Nick Giannoukakis, PhD | Collaborators: National Institutes of Health (NIH)|University of Pittsburgh|University of South Florida|AstraZeneca
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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: |
14
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
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| Start Date: |
2015-11
|
| Completion Date: |
2019-06-15
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| Results First Posted: |
2021-05-13
|
| Last Update Posted: |
2021-05-13
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| Locations: |
Allegheny Health Network, Pittsburgh, Pennsylvania, 15224, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02597101
|
