GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice (GLORY)
- Conditions
- Health Condition 1: null- Type-2 Diabetes
- Registration Number
- CTRI/2013/12/004227
- Lead Sponsor
- Bayer Zydus Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 10000
Patient will be enrolled after the decision to administer acarbose/metformin fixed dose combination for type-2 diabetes management has been made by the attending physician on the basis of best clinical practice and patient needs.
Willing to give informed consent for participating in this study
Patients receiving anti-diabetic medication other than acarbose, or metformin monotherapy at the time of enrollment in the study will be excluded. However, during observation period, any additional anti-diabetics medication administered by the attending physician will be allowed & recorded in case record form.
Patient receiving acarbose/metformin fixed dose combination during 3-months prior to enrollment.
Exclusion criteria should be read in conjunction with local product information
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse eventsTimepoint: 24 weeks
- Secondary Outcome Measures
Name Time Method Incidence of adverse events other than hypoglycemia reported <br/ ><br> <br/ ><br>Timepoint: 24 weeks <br/ ><br>Mean change in HbA1c level <br/ ><br>Mean change in fasting blood sugar <br/ ><br>Mean change in postprandial blood sugar <br/ ><br>Mean change in body weight <br/ ><br>Mean change in serum LDL(lowâ??density lipoprotein) cholesterol <br/ ><br>Mean change in serum triglyceride <br/ ><br>Mean change in serum HDL (High density lipoproteins) cholesterol <br/ ><br>Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale <br/ ><br>Number of patient with adverse event (Tolerability) <br/ ><br>