| Trial ID: | L6435 |
| Source ID: | NCT01316861
|
| Associated Drug: |
Ems Acarbose
|
| Title: |
Efficacy and Safety of Oral Acarbose Treatment in Patients With Type 2 Diabetes Mellitus
|
| Acronym: |
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: EMS Acarbose|DRUG: Bayer Acarbose
|
| Outcome Measures: |
Primary: Glycosylated hemoglobin (HbA1c), Change from baseline to day 98 | Secondary: Decrease in mean Fasting Plasma Glucose (FPG), Change from baseline to day 14, 28, 42, 70 and 98|Safety will be evaluated by the Adverse events occurence, Adverse events will be collected and followed in order to evaluate safety and tolerability, Day 105
|
| Sponsor/Collaborators: |
Sponsor: EMS
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE3
|
| Enrollment: |
79
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2012-09
|
| Completion Date: |
2013-05
|
| Results First Posted: |
|
| Last Update Posted: |
2013-09-25
|
| Locations: |
Marcio Antonio Pereira Clinica, Sao Jose Dos Campos, SP, 12.245-000, Brazil
|
| URL: |
https://clinicaltrials.gov/show/NCT01316861
|
