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

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

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

Study Overview

• Status: Terminated
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Linagliptin; Drug: Acarbose

• Study Type: Observational
• Enrollment (Actual): 85

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100074
    • No.731 Hospital of China Aerospace Science & Industry Corp.
  • Chengdu, China, 610081
    • Affiliated Hospital of Chengdu University
  • Chongqing, China, 400014
    • ChongQing The Fourth Hospital
  • Dongying, China, 257000
    • Dongying People's Hospital
  • Huai'an, China, 223300
    • Huai'an First People's Hospital
  • Nanjing, China, 210008
    • Nanjing Drum Tower Hospital
  • Nanjing, China, 210009
    • Zhongda Hospital Southeast University
  • Shanghai, China, 200000
    • Shanghai TCM-Integrated Hospital
  • Shenzhen, China, 518110
    • Southern Medical University Shenzhen Hospital
  • Suzhou, China, 215699
    • Zhangjiagang First People Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

A total of 500 outpatients with T2DM from 16 sites distributed in different regions in mainland China.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Linagliptin Initiators	Drug: Linagliptin; drug; Other Names: Trajenta®
Acarbose Initiators	Drug: Acarbose; drug

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of T2DM patients with high medication adherence at Week 24	24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 4, 2020
• Primary Completion (Actual): July 11, 2021
• Study Completion (Actual): July 11, 2021

Study Registration Dates

• First Submitted: November 26, 2019
• First Submitted That Met QC Criteria: November 26, 2019
• First Posted (Actual): November 29, 2019

Study Record Updates

• Last Update Posted (Actual): June 23, 2022
• Last Update Submitted That Met QC Criteria: June 20, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Protease Inhibitors; Incretins; Dipeptidyl-Peptidase IV Inhibitors; Glycoside Hydrolase Inhibitors; Linagliptin; Acarbose
• Other Study ID Numbers: 1218-0184

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No