| Trial ID: | L3870 |
| Source ID: | NCT02064881
|
| Associated Drug: |
Metformin Glycinate
|
| Title: |
Efficacy Study of Metformin Glycinate on Postprandial Lipemia
|
| Acronym: |
|
| Status: |
UNKNOWN
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Metformin glycinate|DRUG: Metformin Hydrochloride
|
| Outcome Measures: |
Primary: Change in postprandial lipemia at 4 months, baseline, 4 months | Secondary: Change in oxidized LDL at 4 months, baseline, 4 months|Change in FGF-21 levels at 4 months, baseline, 4 months|Change in A1C at 4 months, baseline, 4 months|Change in alanine aminotransferase at 4 months, baseline, 4 months|Change in uric acid at 4 months, baseline, 4 months|Number of Participants with Serious and Non-Serious Adverse Events, up to 4 months
|
| Sponsor/Collaborators: |
Sponsor: Laboratorios Silanes S.A. de C.V. | Collaborators: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE2|PHASE3
|
| Enrollment: |
72
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2015-10
|
| Completion Date: |
2020-08
|
| Results First Posted: |
|
| Last Update Posted: |
2018-01-30
|
| Locations: |
Instituto Nacional de Ciencias Médicas Y Nutrición Salvador Zubirán, México, Distrito Federal, 14000, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT02064881
|
