| Trial ID: | L3295 |
| Source ID: | NCT01951235
|
| Associated Drug: |
Imeglimin
|
| Title: |
A Study of the Efficacy and Safety of 4 Doses of Imeglimin After 24 Weeks of Treatment in Subjects With Type 2 Diabetes
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Imeglimin|DRUG: Placebo
|
| Outcome Measures: |
Primary: Change in HbA1c, Baseline and week 24 | Secondary: Safety will be assessed by the incidence of adverse events (AEs), physical examination, relevant changes on laboratory tests, vital signs, and 12-lead electrocardiograms (ECG), Baseline to week 24
|
| Sponsor/Collaborators: |
Sponsor: Poxel SA
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2
|
| Enrollment: |
315
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2013-01
|
| Completion Date: |
2014-07
|
| Results First Posted: |
|
| Last Update Posted: |
2015-08-13
|
| Locations: |
Pauls Stradins Clinical University Hospital, Riga, Latvia
|
| URL: |
https://clinicaltrials.gov/show/NCT01951235
|
