Real-world Study Comparing the Adherence and Effectiveness of Linagliptin vs. Acarbose
- Registration Number
- NCT04180813
- Lead Sponsor
- Boehringer Ingelheim
- 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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 85
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Acarbose Initiators Acarbose - Linagliptin Initiators Linagliptin -
- Primary Outcome Measures
Name Time Method Proportion of T2DM patients with high medication adherence at Week 24 24 weeks
- Secondary Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (10)
Huai'an first people's hospital
🇨🇳Huai'an, China
Dongying People's Hospital
🇨🇳Dongying, China
Zhongda Hospital Southeast University
🇨🇳Nanjing, China
Shanghai TCM-Integrated Hospital
🇨🇳Shanghai, China
Zhangjiagang First People Hospital
🇨🇳Suzhou, China
Southern Medical University Shenzhen Hospital
🇨🇳Shenzhen, China
ChongQing The Fourth Hospital
🇨🇳Chongqing, China
No.731 Hospital of China Aerospace Science & Industry Corp.
🇨🇳Beijing, China
Affiliated Hospital of Chengdu University
🇨🇳Chengdu, China
Nanjing Drum Tower Hospital
🇨🇳Nanjing, China