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

Diabetes Mellitus, Type 2 Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04180813
• Other study ID #: 1218-0184
• Status: Terminated
• Start date: March 4, 2020
• Est. completion date: July 11, 2021

Study information

• Verified date: June 2022
• Source: Boehringer Ingelheim
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 85
• Est. completion date: July 11, 2021
• Est. primary completion date: July 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2

Intervention

Drug:
• Linagliptin
drug
• Acarbose
drug

Locations

Country	Name	City	State
China	No.731 Hospital of China Aerospace Science & Industry Corp.	Beijing
China	Affiliated Hospital of Chengdu University	Chengdu
China	ChongQing The Fourth Hospital	Chongqing
China	Dongying People's Hospital	Dongying
China	Huai'an first people's hospital	Huai'an
China	Nanjing Drum Tower Hospital	Nanjing
China	Zhongda Hospital Southeast University	Nanjing
China	Shanghai TCM-Integrated Hospital	Shanghai
China	Southern Medical University Shenzhen Hospital	Shenzhen
China	Zhangjiagang First People Hospital	Suzhou

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of T2DM patients with high medication adherence at Week 24		24 weeks
Secondary	The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups		24 weeks
Secondary	Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c = 0.5%		24 weeks
Secondary	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
Secondary	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

External Links

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