Status:
COMPLETED
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)
Lead Sponsor:
Bayer
Conditions:
Type 2 Diabetes Mellitus
Eligibility:
All Genders
18+ years
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 treat...
Eligibility Criteria
Inclusion
- Newly diagnosed T2DM (diagnosed within last 3 to 6 months) patient eligible for dual therapy exhibiting HbA1c is ≥ 7.5% to 9.0% will be enrolled after 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.
- Decision to initiate treatment with Acarbose/Metformin FDC was made as per Investigator's routine treatment practice
- Signed informed consent
- No participation in an investigational program with interventions outside of routine clinical practice
- No contra-indications according to the local prescribing information of GlucobayM
Exclusion
- Patients receiving any other anti-diabetic medication than the study drug 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 acceptable \& recorded in case record form.
- Patients with type 1 diabetes
- Patients with HbA1c \> 9%
- Patients who have serious infection, or have severe trauma
- Patients who are pregnant or breast-feeding, or have the potential to become pregnant and child bearing female patients who are not willing to use any birth control measures
- All contra-indications according to the local marketing authorization should be considered
- Patients with HbA1c with \>9.0%: The target patient population is selected based on the AACE guideline recommendation to use combination therapy in case of higher glycaemia (HbA1c ≥7.5% - 9.0%) presented on diagnosis and also it is the common practice observed in India of using combination therapy in this group of patient as an initial therapy.
Key Trial Info
Start Date :
December 21 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
September 5 2024
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT04665570
Start Date
December 21 2020
End Date
September 5 2024
Last Update
September 23 2024
Active Locations (1)
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1
Many locations
Multiple Locations, India