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

Not Applicable

Recruiting

• Conditions: Mallya
• Interventions: Other: Mallya cap; Other: Standard care

• Registration Number: NCT05591391
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-28
• Status Verified: 2022-10
• Study First Submitted: 2022-10-02
• Study First Submitted QC: 2022-10-21
• Last Update Submitted: 2022-10-21
• Study First Posted: 2022-10-24
• Last Update Posted: 2022-10-24
• Primary Completion: 2025-06-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mallya	Mallya cap	Patients use Mallya cap to record the time and dosage of insulin injection
Standard care	Standard care	Patients receive standard care.

Primary Outcome Measures

Name	Time	Method
Time in range	7 days of CGM data	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Division of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan