Many locations
Multiple Locations, India
NCT Number: NCT04665570
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.
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Multiple Locations, India
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily
Time frame: From baseline to end of week 24
HbA1c: Glycated Hemoglobin
Time frame: From baseline to end of week 12
Time frame: From baseline to end of week 6, week 12, week 24
Time frame: From baseline to end of week 6, week 12, week 24
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline to end of week 12, week 24
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
Time frame: From baseline up to 24 weeks
AEs assessed and recorded by the physician on the AE report form attached to the case report form
Bayer
Industry
Acarbose/Metformin Fixed Dose Combination: Treatment Patterns and Outcomes in Newly Diagnosed T2DM Patients in India
Acronym: START-AM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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