| Trial ID: | L2814 |
| Source ID: | NCT01819272
|
| Associated Drug: |
Met Dr
|
| Title: |
Assessing the Efficacy, Safety, and Tolerability of Met DR in Subjects With T2DM Over 12 Weeks
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
YES
|
| Results: |
https://ClinicalTrials.gov/show/NCT01819272/results
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Met DR|DRUG: Met XR|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in Fasting Plasma Glucose (mg/dL) at 4 Weeks, Baseline and 4 weeks after the first dose of study medication | Secondary: AUC4-12wk of Change in Fasting Plasma Glucose (mg/dL*Week) Concentrations From Baseline to 12 Weeks, Baseline and 4 to 12 weeks after the first dose of study medication|Change in HbA1c (%) at 12 Weeks, Baseline and 12 weeks after the first dose of study medication
|
| Sponsor/Collaborators: |
Sponsor: Elcelyx Therapeutics, Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
240
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-04
|
| Completion Date: |
2013-09
|
| Results First Posted: |
2015-09-21
|
| Last Update Posted: |
2017-03-15
|
| Locations: |
|
| URL: |
https://clinicaltrials.gov/show/NCT01819272
|
