The study is designed as non interventional to collect data on the safety especially, severe hypoglycemia or documented symptomatic hypoglycemic episodes and effectiveness of acarbose/metformin fixed-dose combination under real-life treatment condition in large sample of type-2 diabetes patients in India. The study objective is to evaluate severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events. The study will begin after the study approval by ethics committee. All patients with type 2 diabetes on acarbose or metformin monotherapy and prescribed Glucobay M will be included in study after taking the informed consent. Patients will be observed for up to 24 weeks (2 weeks).The study involves general examination of patients, collection of data like history of disease, concomitant medication, drug dose etc. The study is planned to enroll 10000 subjects from multiple study centers spread across India. The study data will be analyzed with appropriate statistical methods.
Study Type
OBSERVATIONAL
Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.
Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events
Time frame: 24 weeks
Incidence of adverse events other than hypoglycemia reported
Time frame: 24 weeks
Mean change in HbA1c level
Time frame: baseline and 24 weeks
Mean change in fasting blood sugar
Time frame: baseline and 24 weeks
Mean change in postprandial blood sugar
Time frame: baseline and 24 weeks
Mean change in body weight
Time frame: baseline and 24 weeks
Mean change in serum LDL(low-density lipoprotein) cholesterol
Time frame: baseline and 24 weeks
Mean change in serum triglyceride
Time frame: baseline and 24 weeks
Mean change in serum HDL (High density lipoproteins) cholesterol
Time frame: baseline and 24 weeks
Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale
Time frame: baseline and 24 weeks
Number of patient with adverse event (Tolerability)
Time frame: Baseline and 24 weeks
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