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)
- Conditions
- Type 2 Diabetes Mellitus
- Registration Number
- NCT04665570
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 2000
Inclusion Criteria:<br><br> - Newly diagnosed T2DM (diagnosed within last 3 to 6 months) patient eligible for dual<br> therapy exhibiting HbA1c is = 7.5% to 9.0% will be enrolled after decision to<br> administer acarbose/metformin fixed dose combination for type-2 diabetes management<br> has been made by the attending physician on the basis of best clinical practice and<br> patient needs.<br><br> - Decision to initiate treatment with Acarbose/Metformin FDC was made as per<br> Investigator's routine treatment practice<br><br> - Signed informed consent<br><br> - No participation in an investigational program with interventions outside of routine<br> clinical practice<br><br> - No contra-indications according to the local prescribing information of GlucobayM<br><br>Exclusion Criteria:<br><br> - Patients receiving any other anti-diabetic medication than the study drug at the<br> time of enrollment in the study will be excluded. However, during observation<br> period, any additional anti-diabetics medication administered by the attending<br> physician will be acceptable & recorded in case record form.<br><br> - Patients with type 1 diabetes<br><br> - Patients with HbA1c > 9%<br><br> - Patients who have serious infection, or have severe trauma<br><br> - Patients who are pregnant or breast-feeding, or have the potential to become<br> pregnant and child bearing female patients who are not willing to use any birth<br> control measures<br><br> - All contra-indications according to the local marketing authorization should be<br> considered<br><br> - Patients with HbA1c with >9.0%: The target patient population is selected based on<br> the AACE guideline recommendation to use combination therapy in case of higher<br> glycaemia (HbA1c =7.5% - 9.0%) presented on diagnosis and also it is the common<br> practice observed in India of using combination therapy in this group of patient as<br> an initial therapy.
Not provided
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Mean change in HbA1c
- Secondary Outcome Measures
Name Time Method