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Type 2 Diabetes MellitusSTART-AMNCT04665570

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)

An observational study of Type 2 Diabetes Mellitus, run by Bayer at 1 site in India.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Type 2 Diabetes Mellitus
What is being tested?
BAY81-9783 (Acarbose/Metformin)
Type of treatment
Pill or oral medicine
How many people
2,000 participants
Where
1 siteIndia
Study dates
21 Dec 2020to 5 Sep 2024
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Female and male patients ≥ 18 years or older with a diagnosis of T2DM will be enrolled after the decision for treatment with acarbose/metformin FDC has been made by the Investigator. Patients who have been prescribed acarbose/metformin FDC for a medically appropriate use will be eligible to be enrolled.

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

India1 site

  • Many locations

    Multiple Locations

Other trials in India

About this study

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

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.

Being tested
BAY81-9783 (Acarbose/Metformin)
Medical subject headings
Diabetes Mellitus, Type 2

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BAY81-9783 (Acarbose/Metformin)Drug

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

Study groups in NCT04665570
Study groupRoleWhat they receive
TreatmentThe 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.
Receives: Drug: BAY81-9783 (Acarbose/Metformin)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean change in HbA1c

    HbA1c: Glycated Hemoglobin

    Measured: From baseline to end of week 24

Secondary outcomes (21)

  1. Change in HbA1c

    Measured: From baseline to end of week 12

  2. Change in fasting blood glucose

    Measured: From baseline to end of week 6, week 12, week 24

  3. Change in postprandial glucose level

    Measured: From baseline to end of week 6, week 12, week 24

  4. Occurrence of Hypoglycemic events

    Measured: From baseline up to 24 weeks

  5. Severity of Hypoglycemic events

    Measured: From baseline up to 24 weeks

  6. Occurrence of Gastrointestinal intolerance

    Measured: From baseline up to 24 weeks

  7. Occurrence of other AEs relating to tolerability

    Measured: From baseline up to 24 weeks

  8. Change in patient tolerability to therapy

    Measured: From baseline up to 24 weeks

  9. Mean change in body weight

    Measured: From baseline to end of week 12, week 24

  10. Mean change in lipid profile

    Measured: From baseline up to 24 weeks

  11. Descriptive analysis of starting dose and final dosing

    Measured: From baseline up to 24 weeks

  12. Descriptive analysis of time taken for full dose titration

    Measured: From baseline up to 24 weeks

  13. Descriptive analysis of PPG recorded at each visit

    Measured: From baseline up to 24 weeks

  14. Descriptive analysis of FBG recorded at each visit

    Measured: From baseline up to 24 weeks

  15. Descriptive analysis of HbA1c recorded at each visit

    Measured: From baseline up to 24 weeks

  16. Descriptive analysis of body weight recorded at each visit

    Measured: 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

    Measured: From baseline up to 24 weeks

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

    Measured: From baseline up to 24 weeks

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

    Measured: From baseline up to 24 weeks

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

    Measured: From baseline up to 24 weeks

  21. Descriptive analysis of adverse events (AEs)

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

    Measured: From baseline up to 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2020
  2. Study start21 Dec 2020
  3. Primary completion9 Sep 2023
  4. Study completion5 Sep 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,000 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04665570
Sponsor's protocol ID
21455
Acronym
START-AM
Status last verified
Sep 2024
First submitted
23 Oct 2020
Last updated
23 Sep 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

Questions about this trial

What is this clinical trial studying?

An observational study of Type 2 Diabetes Mellitus, run by Bayer at 1 site in India.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean change in HbA1c (time frame: From baseline to end of week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04665570.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.

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