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)

Type 2 Diabetes Mellitus Clinical Trial

— START-AM  

Official title:

Acarbose/Metformin Fixed Dose Combination: Treatment Patterns and Outcomes in Newly Diagnosed T2DM Patients in India

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04665570
• Other study ID #: 21455
• Status: Active, not recruiting
• Start date: December 21, 2020
• Est. completion date: May 31, 2024

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 2000
• Est. completion date: May 31, 2024
• Est. primary completion date: September 9, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• BAY81-9783 (Acarbose/Metformin)
Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily

Locations

Country	Name	City	State
India	Many locations	Multiple Locations

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change in HbA1c	HbA1c: Glycated Hemoglobin	From baseline to end of week 24
Secondary	Change in HbA1c		From baseline to end of week 12
Secondary	Change in fasting blood glucose		From baseline to end of week 6, week 12, week 24
Secondary	Change in postprandial glucose level		From baseline to end of week 6, week 12, week 24
Secondary	Occurrence of Hypoglycemic events		From baseline up to 24 weeks
Secondary	Severity of Hypoglycemic events		From baseline up to 24 weeks
Secondary	Occurrence of Gastrointestinal intolerance		From baseline up to 24 weeks
Secondary	Occurrence of other AEs relating to tolerability		From baseline up to 24 weeks
Secondary	Change in patient tolerability to therapy		From baseline up to 24 weeks
Secondary	Mean change in body weight		From baseline to end of week 12, week 24
Secondary	Mean change in lipid profile		From baseline up to 24 weeks
Secondary	Descriptive analysis of starting dose and final dosing		From baseline up to 24 weeks
Secondary	Descriptive analysis of time taken for full dose titration		From baseline up to 24 weeks
Secondary	Descriptive analysis of PPG recorded at each visit		From baseline up to 24 weeks
Secondary	Descriptive analysis of FBG recorded at each visit		From baseline up to 24 weeks
Secondary	Descriptive analysis of HbA1c recorded at each visit		From baseline up to 24 weeks
Secondary	Descriptive analysis of body weight recorded at each visit		From baseline up to 24 weeks
Secondary	Descriptive analysis of actual duration of treatment with acarbose/metformin FDC before addition of other anti-diabetes drugs		From baseline up to 24 weeks
Secondary	Descriptive analysis of time of addition of the other anti-diabetes drug		From baseline up to 24 weeks
Secondary	Descriptive analysis of reason of addition of the other anti-diabetes drug		From baseline up to 24 weeks
Secondary	Descriptive analysis of reason for discontinuation of acarbose/metformin FDC treatment		From baseline up to 24 weeks
Secondary	Descriptive analysis of adverse events (AEs)	AEs assessed and recorded by the physician on the AE report form attached to the case report form	From baseline up to 24 weeks