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The Efficacy of Mallya in Type 2 Diabetes Transiting From Oral Antidiabetic Drugs to iGlarLixi

NCT05591391 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-10-24

No results posted yet for this study

Summary

This is a randomized, 12-week, open-label, active-controlled, parallel group study that will collect data of real-time continuous glucose monitoring for seven days at baseline and the end of study from adults with Type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs transiting to their first injectable therapy, iGlarLixi. A total of 40 patients will be recruited in Taipei Veterans General Hospital and randomized to use Mallya or receive standard care. The study is designed to demonstrate the efficacy of Mallya compared to standard care in terms of time in range (glucose level of 70-180 mg/dL), time above range (glucose level ≥180 mg/dL), time below range (glucose level \<70 mg/dL), glycemic variability indices, changes in HbA1c and percentage of patients with HbA1c ≤7.0% at endpoint, time to stable dose, and diabetes treatment satisfaction. The result of the current study will provide insights into the utility of Mallya as a treatment monitoring solution to improve glycemic control.

Conditions

  • Mallya

Interventions

OTHER

Mallya cap

After Mallya cap is correctly attached to the insulin pen, it will automatically record treatment information (dose, time and date of injection) and send in real time to the Health2Sync's platform by Bluetooth transmission. Suggestions regarding dose titration and glycemic control will be communicated on the Health2Sync's platform.

OTHER

Standard care

Suggestions regarding dose titration and glycemic control will be communicated by weekly telephone calls.

Sponsors & Collaborators

  • Taipei Veterans General Hospital, Taiwan

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-28
Primary Completion
2025-06-30
Completion
2025-06-30

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05591391 on ClinicalTrials.gov