| Trial ID: | L6835 |
| Source ID: | NCT01386671
|
| Associated Drug: |
Metformin Glycinate
|
| Title: |
Metformin Glycinate on Metabolic Control and Inflammatory Mediators in Type 2 Diabetes
|
| Acronym: |
COMET
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes
|
| Interventions: |
DRUG: Metformin glycinate|DRUG: Metformin hydrochloride
|
| Outcome Measures: |
Primary: Glycosylated hemoglobin (HbA1c), HbA1c: Measured by electrophoresis of lacked total blood using Paragon system and Appraise reader 44800 (Beckman Instruments de Mexico). Fasting Glucose: in serum using glucose oxidase technique with BM/Hitachi 704/911 automated analyzer, 12 months | Secondary: Fasting glucose, 12 months|Total cholesterol, 12 months|High-density lipoprotein (HDL), 12 months|Low-density lipoprotein (LDL), 12 months|Triglycerides, 12 months|Tumor necrosis factor-alpha (TNF-α), 12 months|Adiponectin, 12 months|Resistin, 12 months|Interleukin-1 beta (IL-1β), 12 months|Number of Adverse Events as a Measure of Safety and Tolerability, 12 months|Malonylaldehyde, 12 months|Dismutase superoxide, 12 months
|
| Sponsor/Collaborators: |
Sponsor: Laboratorios Silanes S.A. de C.V.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
203
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2014-06
|
| Completion Date: |
2018-01
|
| Results First Posted: |
|
| Last Update Posted: |
2018-01-30
|
| Locations: |
Unidad Antidiabética Integral, Mexico City, AA, 06600, Mexico|Paracelsus S.A. de C.V., Mexico, city, AA, 03800, Mexico|Unidad de Investigacion en Epidemiologia Clinica. UMAE Hospital de Especialidades Centro Medico Nacional Siglo XXI. Instituto Mexicano del Seguro Social, Mexico City, Distrito Federal, 06720, Mexico|Instituto de terapéutica experimental y clínica (INTEC), Guadalajara, Jalisco, 44600, Mexico
|
| URL: |
https://clinicaltrials.gov/show/NCT01386671
|
