GLucobay M - Evaluation Of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice

Study Overview
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Brief Summary
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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.

Official Title
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Glucobay M - Evaluation of Safety and Effectiveness in Type 2 Diabetes Not Well Controlled on Monotherapy in Real Life Practice

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Acarbose/Metformin (Glucobay M, BAY81-9783)<br>* Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events other than hypoglycemia reported |  | 24 weeks | 
| Mean change in HbA1c level |  | baseline and 24 weeks | 
| Mean change in fasting blood sugar |  | baseline and 24 weeks | 
| Mean change in postprandial blood sugar |  | baseline and 24 weeks | 
| Mean change in body weight |  | baseline and 24 weeks | 
| Mean change in serum LDL(low-density lipoprotein) cholesterol |  | baseline and 24 weeks | 
| Mean change in serum triglyceride |  | baseline and 24 weeks | 
| Mean change in serum HDL (High density lipoproteins) cholesterol |  | baseline and 24 weeks | 
| Change in percent satisfaction to the therapy from baseline as measured by 5 point satisfaction scale |  | baseline and 24 weeks | 
| Number of patient with adverse event (Tolerability) |  | Baseline and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetes Mellitus, Type 2 Diabetes, Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination