Type 2 Diabetes Mellitus
Conditions
Brief summary
The Purpose of This Study is to Evaluate the Efficacy and Safety of Acarbose in Type 2 Diabetic Patients Using Two Different Formulations of Acarbose 50mg.
Detailed description
Study Design: * Multicenter * Phase III * Randomized * Double Blind * Prospective and Comparative * Experiment duration: 105 days * 5 visits * Efficacy * Adverse event
Interventions
DRUGEMS Acarbose
EMS Acarbose 50 mg 3 times a day
DRUGBayer Acarbose
Bayer Acarbose 50 mg 3 times a day
Sponsors
EMS
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients must be able to understand the study procedures agree to participate and give written consent. * Diagnosed with type 2 diabetes mellitus (t2dm)b * Female patients of childbearing potential (i.e., ovulating, pre-menopausal, not surgically sterile) which agree to use a medically accepted contraceptive regimen for the duration of the study.
Exclusion criteria
* Pregnancy or risk of pregnancy. * Lactation * Any pathology or past medical condition that can interfere with this protocol * Other conditions deemed reasonable by the medical investigator as to the disqualification of the individual from study participation. * Known hypersensitivity / intolerance to acarbose or any of its excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Glycosylated hemoglobin (HbA1c) | Change from baseline to day 98 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Day 105 | Adverse events will be collected and followed in order to evaluate safety and tolerability |
Countries
Brazil
Outcome results
None listed