| Trial ID: | L3826 |
| Source ID: | NCT02444910
|
| Associated Drug: |
Kdt501
|
| Title: |
Effects of KDT501 on Metabolic Features in Insulin Resistant Subjects
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: KDT501
|
| Outcome Measures: |
Primary: Change from baseline of the 2 hour oral glucose tolerance test (OGTT) at day 28., The change in serum glucose 2 hours following the administration of 75gm of oral glucose (2 hour oral glucose tolerance test (OGTT)) will be calculated as the difference in 2 hour OGTT at Day 28 (±2 days) vs. baseline., 28 days (± 2 days) | Secondary: Change in Resting Metabolic Rate (RMR), The change in RMR will be calculated as the difference in RMR at Day 27 (±4 days) vs. baseline., 27 days (±4 days)|Change in Lipid Tolerance Test, The change in lipid tolerance test parameters will be calculated as the difference at Day 27 (±4 days) vs. baseline., 27 days (±4 days)|Change in HbA1c, fructosamine, and glycated albumin, The change in each of these assay results will be calculated as the difference at Day 27 (±4 days) vs. baseline., 27 days (±4 days)|Change in Fasting Plasma Glucose, The change in fasting plasma glucose will be calculated as the difference at Day 27 (±4 days) vs. baseline., 27 days (±4 days)|Change in Insulin Sensitivity Based on Euglycemic Clamp Study, The change in insulin sensitivity will be calculated as the difference at Day 27 (±4 days) vs. baseline., 27 days (±4 days)
|
| Sponsor/Collaborators: |
Sponsor: KinDex Pharmaceuticals, Inc. | Collaborators: University of Kentucky
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
9
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
|
| Start Date: |
2015-04
|
| Completion Date: |
2015-11
|
| Results First Posted: |
|
| Last Update Posted: |
2017-10-20
|
| Locations: |
University of Kentucky's Center for Clinical and Translational Science (CCTS), Lexington, Kentucky, 40536-0298, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT02444910
|
