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

Sponsor
Boehringer Ingelheim (Industry)
Overall Status
Terminated
CT.gov ID
NCT04180813
Collaborator
(none)
85
Enrollment
10
Locations
16.2
Actual Duration (Months)
8.5
Patients Per Site
0.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Actual Enrollment :
85 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Mar 4, 2020
Actual Primary Completion Date :
Jul 11, 2021
Actual Study Completion Date :
Jul 11, 2021

Arms and Interventions

Arm Intervention/Treatment
Linagliptin Initiators

Drug: Linagliptin
drug
Other Names:
  • Trajenta®

    		•
    Acarbose Initiators

    Drug: Acarbose
    drug

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of T2DM patients with high medication adherence at Week 24 [24 weeks]

    Secondary Outcome Measures

    1. The effectiveness of linagliptin and acarbose on glycemic control evaluated by reducing HbA1c during a 24 week follow-up in two groups [24 weeks]

    2. Proportion of T2DM patients achieving a therapeutic glycemic response defined as HbA1c < 7.0% or a lowering of HbA1c ≥ 0.5% [24 weeks]

    3. 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]

    4. 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]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 No.731 Hospital of China Aerospace Science & Industry Corp. Beijing China 100074
    2 Affiliated Hospital of Chengdu University Chengdu China 610081
    3 ChongQing The Fourth Hospital Chongqing China 400014
    4 Dongying People's Hospital Dongying China 257000
    5 Huai'an first people's hospital Huai'an China 223300
    6 Nanjing Drum Tower Hospital Nanjing China 210008
    7 Zhongda Hospital Southeast University Nanjing China 210009
    8 Shanghai TCM-Integrated Hospital Shanghai China 200000
    9 Southern Medical University Shenzhen Hospital Shenzhen China 518110
    10 Zhangjiagang First People Hospital Suzhou China 215699

    Sponsors and Collaborators

    • Boehringer Ingelheim

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Boehringer Ingelheim
    ClinicalTrials.gov Identifier:
    NCT04180813
    Other Study ID Numbers:
    • 1218-0184
    First Posted:
    Nov 29, 2019
    Last Update Posted:
    Jun 23, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Diabetes Mellitus, Type 2
    Linagliptin
    Acarbose

    Study Results

    No Results Posted as of Jun 23, 2022