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

The Efficacy of Mallya in Type 2 Diabetes Transiting From Oral Antidiabetic Drugs to iGlarLixi: a Randomized Controlled Trial Using Real-time Continuous Glucose Monitoring

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.

Study Overview

• Status: Recruiting
• Conditions: Mallya
• Intervention / Treatment: Other: Mallya cap; Other: Standard care

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Chun-Jui Huang, PhD; Phone Number: 0938590679; Email: cjhuang3@vghtpe.gov.tw

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Division of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital
    • Contact: Chun-Jui Huang, PhD; Phone Number: 0938590679; Email: chunjui0501@yahoo.com.tw

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥20 years-old
• T2DM ≥ 180 days
• HbA1c ≥ 7.0% at screening
• Under stable doses of OADs for ≥12 weeks prior to screening
• Insulin naïve (except short term insulin treatment for a maximum of 14 days before screening and/or prior insulin treatment for gestational diabetes)
• Not currently using real time continuous or flash glucose monitoring
• Not currently using Mallya

Exclusion Criteria:

• Known or suspected hypersensitivity to randomized treatment or related products
• Previous participation in this study (Participation is defined as signed informed consent);
• Participation (i.e., signed informed consent) in any interventional, clinical study within 90 days before screening (except for COVID-19 study);
• Female who is pregnant, breast-feeding or intends to become pregnant
• Presence of severe gastrointestinal disorders, such as severe gastroparesis;
• Presence of severe renal dysfunction (eGFR <30 ml/min/1.73 m2) or end-stage renal disease on dialysis;
• Presence of severe hepatic dysfunction (AST or ALT level ≥ 200 U/L);
• Patients with a history of pancreatitis;
• Patients receiving systemic corticosteroids
• Patients with active cancer within the past six months.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mallya; Patients use Mallya cap to record the time and dosage of insulin injection	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.
Active Comparator: Standard care; Patients receive standard care.	Other: Standard care; Suggestions regarding dose titration and glycemic control will be communicated by weekly telephone calls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range	The time in range (TIR) in percent (%) of a glucose level of 70-180 mg/dL obtained by real-time continuous glucose monitoring (rt-CGM) at the end of the study in both groups.	7 days of CGM data

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time above range (TAR)	Time above range (TAR) in percent (%) of a glucose level ≥180 mg/dL	7 days of CGM data
Time below range (TBR)	Time below range (TBR) in percent (%) of a glucose level <70 mg/dL and nocturnal (00.00-06.00 hours) TBR	7 days of CGM data
Mean of glucose levels	Mean in mg/dL of glucose levels obtained on rt-CGM	7 days of CGM data
Standard deviation (SD) of glucose levels	Standard deviation (SD) in mg/dL of glucose levels obtained on rt-CGM	7 days of CGM data
Coefficient of variation (CV) of glucose levels	Coefficient of variation (CV) in mg/dL of glucose levels obtained on rt-CGM	7 days of CGM data
HbA1c	Changes in HbA1C (post-study HbA1C minus pre-study HbA1C) and percentage of patients with HbA1C ≤7.0%	12 weeks
Time to stable dose	The time (days) for patients to achieve target fasting glucose level and stable dose of iGlarLixiThe	12 weeks
Treatment satisfaction questionnaire	Diabetes Treatment Satisfaction Questionnaire	12 weeks

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 28, 2022
• Primary Completion (Anticipated): June 30, 2025
• Study Completion (Anticipated): June 30, 2025

Study Registration Dates

• First Submitted: October 2, 2022
• First Submitted That Met QC Criteria: October 21, 2022
• First Posted (Actual): October 24, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2022
• Last Update Submitted That Met QC Criteria: October 21, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 2022-07-010B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No