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) (START-AM)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Type 2 Diabetes Mellitus
• Intervention / Treatment: Drug: BAY81-9783 (Acarbose/Metformin)

• Study Type: Observational
• Enrollment (Actual): 2000

Contacts and Locations

• Study Contact: Name: Bayer Clinical Trials Contact; Phone Number: (+)1-888-84 22937; Email: clinical-trials-contact@bayer.com

Study Locations

• India
  • Multiple Locations, India
    • Many locations

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: BAY81-9783 (Acarbose/Metformin); Tablet (FDC of 25/50mg acarbose + 500mg metformin), three times daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean change in HbA1c	HbA1c: Glycated Hemoglobin	From baseline to end of week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1c		From baseline to end of week 12
Change in fasting blood glucose		From baseline to end of week 6, week 12, week 24
Change in postprandial glucose level		From baseline to end of week 6, week 12, week 24
Occurrence of Hypoglycemic events		From baseline up to 24 weeks
Severity of Hypoglycemic events		From baseline up to 24 weeks
Occurrence of Gastrointestinal intolerance		From baseline up to 24 weeks
Occurrence of other AEs relating to tolerability		From baseline up to 24 weeks
Change in patient tolerability to therapy		From baseline up to 24 weeks
Mean change in body weight		From baseline to end of week 12, week 24
Mean change in lipid profile		From baseline up to 24 weeks
Descriptive analysis of starting dose and final dosing		From baseline up to 24 weeks
Descriptive analysis of time taken for full dose titration		From baseline up to 24 weeks
Descriptive analysis of PPG recorded at each visit		From baseline up to 24 weeks
Descriptive analysis of FBG recorded at each visit		From baseline up to 24 weeks
Descriptive analysis of HbA1c recorded at each visit		From baseline up to 24 weeks
Descriptive analysis of body weight recorded at each visit		From baseline up to 24 weeks
Descriptive analysis of actual duration of treatment with acarbose/metformin FDC before addition of other anti-diabetes drugs		From baseline up to 24 weeks
Descriptive analysis of time of addition of the other anti-diabetes drug		From baseline up to 24 weeks
Descriptive analysis of reason of addition of the other anti-diabetes drug		From baseline up to 24 weeks
Descriptive analysis of reason for discontinuation of acarbose/metformin FDC treatment		From baseline up to 24 weeks
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

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Actual): September 9, 2023
• Study Completion (Estimated): March 29, 2024

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: December 7, 2020
• First Posted (Actual): December 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 1, 2024
• Last Update Submitted That Met QC Criteria: March 29, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Glycoside Hydrolase Inhibitors; Metformin; Acarbose
• Other Study ID Numbers: 21455 (University of California, San Francisco)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No