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| ID | Type | Description | Link |
|---|---|---|---|
| GB1310IN | Other Identifier | company intermal |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acarbose/Metformin (Glucobay M, BAY81-9783) | Drug | Acarbose (25/50mg) and Metformin (500mg) in fixed dose combination. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of severe hypoglycemia or documented symptomatic or asymptomatic hypoglycemic events reported as adverse events | 24 weeks |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Type 2 diabetes
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| Name | Affiliation | Role |
|---|---|---|
| Bayer Study Director | Bayer | Study Director |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D020909 | Acarbose |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D014312 | Trisaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| 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 |
| D001645 |
| Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |