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Completed

NCT Number: NCT04665570

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)

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many locations

Multiple Locations, India

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BAY81-9783 (Acarbose/Metformin)

Drug

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

Primary outcomes

  1. Mean change in HbA1c

    Time frame: From baseline to end of week 24

    HbA1c: Glycated Hemoglobin

Secondary outcomes

  1. Change in HbA1c

    Time frame: From baseline to end of week 12

  2. Change in fasting blood glucose

    Time frame: From baseline to end of week 6, week 12, week 24

  3. Change in postprandial glucose level

    Time frame: From baseline to end of week 6, week 12, week 24

  4. Occurrence of Hypoglycemic events

    Time frame: From baseline up to 24 weeks

  5. Severity of Hypoglycemic events

    Time frame: From baseline up to 24 weeks

  6. Occurrence of Gastrointestinal intolerance

    Time frame: From baseline up to 24 weeks

  7. Occurrence of other AEs relating to tolerability

    Time frame: From baseline up to 24 weeks

  8. Change in patient tolerability to therapy

    Time frame: From baseline up to 24 weeks

  9. Mean change in body weight

    Time frame: From baseline to end of week 12, week 24

  10. Mean change in lipid profile

    Time frame: From baseline up to 24 weeks

  11. Descriptive analysis of starting dose and final dosing

    Time frame: From baseline up to 24 weeks

  12. Descriptive analysis of time taken for full dose titration

    Time frame: From baseline up to 24 weeks

  13. Descriptive analysis of PPG recorded at each visit

    Time frame: From baseline up to 24 weeks

  14. Descriptive analysis of FBG recorded at each visit

    Time frame: From baseline up to 24 weeks

  15. Descriptive analysis of HbA1c recorded at each visit

    Time frame: From baseline up to 24 weeks

  16. Descriptive analysis of body weight recorded at each visit

    Time frame: From baseline up to 24 weeks

  17. Descriptive analysis of actual duration of treatment with acarbose/metformin FDC before addition of other anti-diabetes drugs

    Time frame: From baseline up to 24 weeks

  18. Descriptive analysis of time of addition of the other anti-diabetes drug

    Time frame: From baseline up to 24 weeks

  19. Descriptive analysis of reason of addition of the other anti-diabetes drug

    Time frame: From baseline up to 24 weeks

  20. Descriptive analysis of reason for discontinuation of acarbose/metformin FDC treatment

    Time frame: From baseline up to 24 weeks

  21. Descriptive analysis of adverse events (AEs)

    Time frame: From baseline up to 24 weeks

    AEs assessed and recorded by the physician on the AE report form attached to the case report form

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: START-AM

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Dec 11, 2020
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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