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)

NCT ID: NCT04665570

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 2000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-12-21
• Study Completion Date: 2024-09-05

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 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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

BAY81-9783 (Acarbose/Metformin)

Intervention Type: DRUG

Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily

Interventions

BAY81-9783 (Acarbose/Metformin)

Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Many locations

Multiple Locations, , India

Countries

India

Other Identifiers

21455

Identifier Type: -

Identifier Source: org_study_id