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

Taipei Veterans General Hospital

Status: Enrolling

Conditions: Mallya

Treatments: Other: Mallya cap; Other: Standard care

Study type: Interventional

Funder types: Other

Identifiers

NCT05591391

2022-07-010B

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Mallya

Experimental group

Description:

Patients use Mallya cap to record the time and dosage of insulin injection

Treatment:

Other: Mallya cap

Standard care

Active Comparator group

Description:

Patients receive standard care.

Treatment:

Other: Standard care