| Trial ID: | L5518 |
| Source ID: | NCT01677299
|
| Associated Drug: |
Efb0027 (Metformin Delayed Release)
|
| Title: |
Assessing the PK and Effect on Glucose and GI Hormone Concentrations of Metformin Delayed-Release in Subjects With T2DM
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01677299/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: EFB0027 (metformin delayed release)|DRUG: EFB0026 (metformin immediate-release)
|
| Outcome Measures: |
Primary: Area Under the Curve (0-t) of Plasma Metformin, Measures from the time of dosing (0 h) to the time of the last quantifiable concentration following dose administration. The dose of study medication was administered at t = -1 min relative to the start time of the standardized breakfast., Time points at which data were collected to create the area under the curve (0-t) for plasma metformin were: t = -0.08, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 10, and 11 h relative to the start time of the standardized breakfast.|Change in Fasting Plasma Glucose, LS mean difference from Baseline (Day 1) to Day 5, Change from Baseline (Day 1) to Day 5|Within Treatment Comparison Based on Ratios of AUCs of GLP-1, Ratio of Day 5 to Baseline|Within Treatment Comparison Based on Ratios of AUCs of PYY, Ratio of Day 5 to Baseline |
|
| Sponsor/Collaborators: |
Sponsor: Elcelyx Therapeutics, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE1|PHASE2
|
| Enrollment: |
24
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: BASIC_SCIENCE
|
| Start Date: |
2012-05
|
| Completion Date: |
2012-09
|
| Results First Posted: |
2014-06-16
|
| Last Update Posted: |
2016-09-20
|
| Locations: |
Celerion, Inc., Tempe, Arizona, 85283, United States|Celerion, Inc., Lincoln, Nebraska, 68502, United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01677299
|
