do_not_disturb_altRecruitment Complete

Type 2 Diabetes Mellitus

Bayer Identifier:

21455

ClinicalTrials.gov Identifier:

NCT04665570

EudraCT Number:

Not Available

EU CT Number:

Not Available
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)

Trial purpose

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.

Key Participants Requirements

Sex

All

Age

18 - N/A

  • - 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
  • - 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 summary

Enrollment Goal
2000
Trial Dates
December 2020 - August 2024
Phase
Phase 4
Could I Receive a placebo
No
Products
Glucobay M (Acarbose/Metformin, BAY81-9783)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Recruiting
Many locationsMany locations, India

Primary Outcome

  • Mean change in HbA1c
    HbA1c: Glycated Hemoglobin
    date_rangeTime Frame:
    From baseline to end of week 24

Secondary Outcome

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

Trial design

Acarbose/Metformin Fixed Dose Combination: Treatment patterns and Outcomes in Newly Diagnosed T2DM patients in India
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A