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

NCT04180813 | Terminated

• 1 other identifier: 1218-0184
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 10

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

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Proportion of T2DM patients with high medication adherence at Week 24

  24 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Linagliptin Initiators

Drug: Linagliptin

Acarbose Initiators

Drug: Acarbose

Interventions

Linagliptin DRUG

drug

Also known as: Trajenta®

Linagliptin Initiators

Acarbose DRUG

drug

Acarbose Initiators

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (10)

No.731 Hospital of China Aerospace Science & Industry Corp.

Beijing, 100074, China

Location

Affiliated Hospital of Chengdu University

Chengdu, 610081, China

Location

ChongQing The Fourth Hospital

Chongqing, 400014, China

Location

Dongying People's Hospital

Dongying, 257000, China

Location

Huai'an first people's hospital

Huai'an, 223300, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Zhongda Hospital Southeast University

Nanjing, 210009, China

Location

Shanghai TCM-Integrated Hospital

Shanghai, 200000, China

Location

Southern Medical University Shenzhen Hospital

Shenzhen, 518110, China

Location

Zhangjiagang First People Hospital

Suzhou, 215699, China

Location

Related Links

• Related Info

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Linagliptin; Acarbose

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Quinazolines; Trisaccharides; Oligosaccharides; Polysaccharides; Carbohydrates

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2019
• First Posted: November 29, 2019
• Study Start: March 4, 2020
• Primary Completion: July 11, 2021
• Study Completion: July 11, 2021
• Last Updated: June 23, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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'.

Locations

CN (10)