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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

85 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-03-04

Study Completion Date

2021-07-11

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

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Detailed Description

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Conditions

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Diabetes Mellitus, Type 2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Linagliptin Initiators

Linagliptin

Intervention Type DRUG

drug

Acarbose Initiators

Acarbose

Intervention Type DRUG

drug

Interventions

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Linagliptin

drug

Intervention Type DRUG

Acarbose

drug

Intervention Type DRUG

Other Intervention Names

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Trajenta®

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No