Mallya
Conditions
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.
Interventions
OTHERMallya 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.
OTHERStandard care
Suggestions regarding dose titration and glycemic control will be communicated by weekly telephone calls.
Sponsors
Taipei Veterans General Hospital, Taiwan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Time above range (TAR) | 7 days of CGM data | Time above range (TAR) in percent (%) of a glucose level ≥180 mg/dL |
| 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 |
| 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 |
Countries
Taiwan
Contacts
Primary ContactChun-Jui Huang, PhD
Outcome results
None listed