Clinical trial NCT04180813: Real-world Study Comparing the Adherence and Effectiveness of Linagliptin vs. Acarbose
Official title: 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
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2019-11-29
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: A total of 500 outpatients with T2DM from 16 sites distributed in different regions in mainland China.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Proportion of T2DM patients with high medication adherence at Week 24
timeFrame: 24 weeks
Secondary outcomes:
measure: The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups
timeFrame: 24 weeks
measure: Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c ≥ 0.5%
timeFrame: 24 weeks
measure: To compare the composite endpoint (proportion of achieving HbA1c < 7.0% without gastrointestinal adverse events (GI AEs) and without an investigator defined hypoglycaemic event)
timeFrame: 24 weeks
measure: 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
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: No.731 Hospital of China Aerospace Science & Industry Corp.
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University
city: Chongqing
country: China
facility: ChongQing The Fourth Hospital
city: Dongying
country: China
facility: Dongying People's Hospital
city: Huai'an
country: China
facility: Huai'an first people's hospital
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Nanjing
country: China
facility: Zhongda Hospital Southeast University
city: Shanghai
country: China
facility: Shanghai TCM-Integrated Hospital
city: Shenzhen
country: China
facility: Southern Medical University Shenzhen Hospital
city: Suzhou
country: China
facility: Zhangjiagang First People Hospital
Study officials:
References: