Evaluating Mallya for managing Type 2 Diabetes with injectable therapy

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 study is testing if a new monitoring tool called Mallya can help adults with Type 2 diabetes manage their blood sugar better when switching from pills to an injectable treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 20 Years and up
• Sex: All
• Sponsor: Taipei Veterans General Hospital, Taiwan (Government)
• Locations: 1 site (Taipei)
• Trial ID: NCT05591391 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of Mallya, a treatment monitoring solution, in adults with Type 2 diabetes who are transitioning from oral antidiabetic drugs to the injectable therapy iGlarLixi. It is a randomized, 12-week, open-label, active-controlled study that will monitor glucose levels continuously for seven days at both the beginning and end of the study. A total of 40 patients will be recruited and assigned to either Mallya or standard care, with outcomes measured in terms of glucose control, glycemic variability, and patient satisfaction. The goal is to determine if Mallya can improve diabetes management compared to standard care.

Who should consider this trial

Good fit: Ideal candidates are adults aged 20 and older with Type 2 diabetes inadequately controlled on oral medications and who are insulin naïve.

Not a fit: Patients with severe gastrointestinal disorders, severe renal dysfunction, or those currently using continuous glucose monitoring may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new tool for better glucose management in patients with Type 2 diabetes transitioning to injectable therapies.

How similar studies have performed: While the specific use of Mallya is novel, similar studies have shown that effective monitoring can significantly improve diabetes management outcomes.

Eligibility criteria

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.

Where this trial is running

Taipei

• Division of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital — Taipei, Taiwan (Recruiting)

Study contacts

• Study coordinator: Chun-Jui Huang, PhD

Conditions Mallya