Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04665570
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2020-10-23
Brief Title:
A Study to Learn More About How Acarbose and Metformin Work When Taken Together and How Safe They Are in Indian Patients Who Were Recently Diagnosed With Type 2 Diabetes T2D
Sponsor:
Bayer
Organization:
Bayer
Study Overview
Official Title:
AcarboseMetformin Fixed Dose Combination Treatment Patterns and Outcomes in Newly Diagnosed T2DM Patients in India
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
START-AM
Brief Summary:
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 2000 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 doctors 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
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 2000 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 doctors 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None