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The study drug, fixed dose combination of acarbose and metformin, have already been approved to take together as a treatment for type 2 diabetes (T2D). Sometimes, researchers continue studying a treatment after it has been approved to learn more about how doctors decide which treatment to give to patients. In this study, the researchers want to learn more about how acarbose and metformin work when taken together and if the patients have any medical problems.
The study will include patients with T2D that was diagnosed in the last 3 to 6 months. These patients will also have recently started treatment with acarbose and metformin. The study will include about 2,000 men and women in India who are at least 18 years old.
All of the patients will take fixed dose combination of acarbose and metformin tablets based on their doctor's instructions. They will then visit their study site 4 times over 6 months. At these visits, their doctors will ask them questions about how they are feeling and what medications they are taking. If require, the doctors will take blood samples to measure the patients' blood sugar levels as per routine practice. The doctors will also do physical examinations and check the patients' overall health.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | The decision to prescribe Acarbose/Metformin fixed dose combination (FDC) will be solely at the discretion of the Investigator and in accordance with his/her experience. Patients can only be enrolled in the study if the decision to treat with Acarbose/Metformin fixed dose combination has been made by the treating physician in advance and independent of study inclusion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BAY81-9783 (Acarbose/Metformin) | Drug | Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change in HbA1c | HbA1c: Glycated Hemoglobin | From baseline to end of week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c | From baseline to end of week 12 | |
| Change in fasting blood glucose | From baseline to end of week 6, week 12, week 24 | |
| Change in postprandial glucose level |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male patients ≥ 18 years or older with a diagnosis of T2DM will be enrolled after the decision for treatment with acarbose/metformin FDC has been made by the Investigator. Patients who have been prescribed acarbose/metformin FDC for a medically appropriate use will be eligible to be enrolled.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Many locations | Multiple Locations | India |
Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.
Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.
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| From baseline to end of week 6, week 12, week 24 |
| Occurrence of Hypoglycemic events | From baseline up to 24 weeks |
| Severity of Hypoglycemic events | From baseline up to 24 weeks |
| Occurrence of Gastrointestinal intolerance | From baseline up to 24 weeks |
| Occurrence of other AEs relating to tolerability | From baseline up to 24 weeks |
| Change in patient tolerability to therapy | From baseline up to 24 weeks |
| Mean change in body weight | From baseline to end of week 12, week 24 |
| Mean change in lipid profile | From baseline up to 24 weeks |
| Descriptive analysis of starting dose and final dosing | From baseline up to 24 weeks |
| Descriptive analysis of time taken for full dose titration | From baseline up to 24 weeks |
| Descriptive analysis of PPG recorded at each visit | From baseline up to 24 weeks |
| Descriptive analysis of FBG recorded at each visit | From baseline up to 24 weeks |
| Descriptive analysis of HbA1c recorded at each visit | From baseline up to 24 weeks |
| Descriptive analysis of body weight recorded at each visit | From baseline up to 24 weeks |
| Descriptive analysis of actual duration of treatment with acarbose/metformin FDC before addition of other anti-diabetes drugs | From baseline up to 24 weeks |
| Descriptive analysis of time of addition of the other anti-diabetes drug | From baseline up to 24 weeks |
| Descriptive analysis of reason of addition of the other anti-diabetes drug | From baseline up to 24 weeks |
| Descriptive analysis of reason for discontinuation of acarbose/metformin FDC treatment | From baseline up to 24 weeks |
| Descriptive analysis of adverse events (AEs) | AEs assessed and recorded by the physician on the AE report form attached to the case report form | From baseline up to 24 weeks |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| 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 |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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