Clinical trial 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)
Official title: Acarbose/Metformin Fixed Dose Combination: Treatment Patterns and Outcomes in Newly Diagnosed T2DM Patients in India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2020-12-11
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Mean change in HbA1c
timeFrame: From baseline to end of week 24
Secondary outcomes:
measure: Change in HbA1c
timeFrame: From baseline to end of week 12
measure: Change in fasting blood glucose
timeFrame: From baseline to end of week 6, week 12, week 24
measure: Change in postprandial glucose level
timeFrame: From baseline to end of week 6, week 12, week 24
measure: Occurrence of Hypoglycemic events
timeFrame: From baseline up to 24 weeks
measure: Severity of Hypoglycemic events
timeFrame: From baseline up to 24 weeks
measure: Occurrence of Gastrointestinal intolerance
timeFrame: From baseline up to 24 weeks
measure: Occurrence of other AEs relating to tolerability
timeFrame: From baseline up to 24 weeks
measure: Change in patient tolerability to therapy
timeFrame: From baseline up to 24 weeks
measure: Mean change in body weight
timeFrame: From baseline to end of week 12, week 24
measure: Mean change in lipid profile
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of starting dose and final dosing
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of time taken for full dose titration
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of PPG recorded at each visit
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of FBG recorded at each visit
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of HbA1c recorded at each visit
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of body weight recorded at each visit
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of actual duration of treatment with acarbose/metformin FDC before addition of other anti-diabetes drugs
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of time of addition of the other anti-diabetes drug
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of reason of addition of the other anti-diabetes drug
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of reason for discontinuation of acarbose/metformin FDC treatment
timeFrame: From baseline up to 24 weeks
measure: Descriptive analysis of adverse events (AEs)
timeFrame: From baseline up to 24 weeks
Other outcomes:
Locations:
city: Multiple Locations
country: India
facility: Many locations
Study officials:
References: