The Efficacy of Mallya in Type 2 Diabetes Transiting From Oral Antidiabetic Drugs to iGlarLixi
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- 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
- Time above range (TAR) [7 days of CGM data]
Time above range (TAR) in percent (%) of a glucose level ≥180 mg/dL
- 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
- Mean of glucose levels [7 days of CGM data]
Mean in mg/dL of glucose levels obtained on rt-CGM
- Standard deviation (SD) of glucose levels [7 days of CGM data]
Standard deviation (SD) in mg/dL of glucose levels obtained on rt-CGM
- 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
- 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
- Treatment satisfaction questionnaire [12 weeks]
Diabetes Treatment Satisfaction Questionnaire
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Division of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital | Taipei | Taiwan |
Sponsors and Collaborators
- Taipei Veterans General Hospital, Taiwan
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2022-07-010B