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

Study Overview
=================
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.

Official Title
-----------------
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

Conditions
-----------------
Mallya

Intervention / Treatment
-----------------
* Other: Mallya cap
* Other: Standard care


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

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

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 |