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

Boehringer Ingelheim

Status: Terminated

Conditions: Diabetes Mellitus, Type 2

Treatments: Drug: Linagliptin; Drug: Acarbose

Study type: Observational

Funder types: Industry

Identifiers

NCT04180813

1218-0184

Details and patient eligibility

About

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

Enrollment: 85 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

85 participants in 2 patient groups

Linagliptin Initiators

Treatment:

Drug: Linagliptin

Acarbose Initiators

Treatment:

Drug: Acarbose