Real-world Study Comparing the Adherence and Effectiveness of Linagliptin vs. Acarbose

Study Overview
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Brief Summary
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Non-interventional cohort study based on newly collected data under routine medical practice of a total of 500 Diabetes Mellitus, Type 2 patients

Official Title
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A Non-interventional Study of Patient Medication Adherence and Treatment Effectiveness Among New Users of Linagliptin and Acarbose in the Real-world Clinical Setting in China

Conditions
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Diabetes Mellitus, Type 2

Intervention / Treatment
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* Drug: Linagliptin
* Drug: Acarbose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient should fully know and understand the content of consent form, and the patient is willing and able to sign an informed consent form Chinese outpatients with confirmed T2DM Patients of ≥ 18, < 80 years old Patients currently use metformin monotherapy ≥ 1500 mg/day or maximum tolerable dose and whose glucose levels are not adequately controlled HbA1c ≥ 7% and < 12% New user* linagliptin or acarbose as combination therapy with metformin ≥ 1500 mg/day or maximum tolerable dose *New user defined as a T2DM patient initiating linagliptin or acarbose as an add-on therapy. These are patients who are on metformin and whose glucose levels are not adequately controlled. Exclusion Criteria: Type 2 diabetes mellitus patients who previously used any DPP-4 inhibitor/ GLP-1 receptor agonist at index date or any AGI at index date, are not eligible to participate. Also excluded are patients who currently using any glucose-lowering agent as monotherapy other than metformin. Patients with clinically significant acute major organ or systemic disease or other condition judged by the investigator that would create difficulty for the 24-week follow-up. Patients who participated in a clinical trial within 2 months prior to study enrolment date. Patients diagnosed with Type 1 diabetes mellitus, secondary diabetes or gestational diabetes. Current treatment with systemic steroids at time of informed consent or within 6 weeks prior to informed consent. Patients with known significant GI disease as judged by the study physician.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Linagliptin Initiators<br> | Drug: Linagliptin<br>* drug<br>* Other names: Trajenta®;|
| Acarbose Initiators<br> | Drug: Acarbose<br>* drug<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of T2DM patients with high medication adherence at Week 24 |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups |  | 24 weeks | 
| Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c ≥ 0.5% |  | 24 weeks | 
| To compare the composite endpoint (proportion of achieving HbA1c < 7.0% without gastrointestinal adverse events (GI AEs) and without an investigator defined hypoglycaemic event) |  | 24 weeks | 
| Patient satisfaction by Diabetes Treatment Satisfaction Questionnaire (DTSQ) among linagliptin and acarbose initiators. The DTSQ would be completed at routine physician visits since initiation of the drug |  | 24 weeks |