MallyaNCT05591391
The Efficacy of Mallya in Type 2 Diabetes Transiting From Oral Antidiabetic Drugs to iGlarLixi
A study testing Mallya cap in people with Mallya, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Mallya
- What is being tested?
- Mallya cap
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 28 Sep 2022to 30 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 10Show fewer
- 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 locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Division of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital
Taipei
Chun-Jui Huang, PhD, 0938590679, chunjui0501@yahoo.com.tw
About this study
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
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.
- Conditions
- Mallya
- Being tested
- Mallya cap, Standard care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mallya capOther
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.
Standard careOther
Suggestions regarding dose titration and glycemic control will be communicated by weekly telephone calls.
| Study group | Role | What they receive |
|---|---|---|
| Mallya | Experimental | Patients use Mallya cap to record the time and dosage of insulin injection Receives: Other: Mallya cap |
| Standard care | Active comparator | Patients receive standard care. Receives: Other: Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days of CGM data
Secondary outcomes (8)
Time above range (TAR)
Time above range (TAR) in percent (%) of a glucose level ≥180 mg/dL
Measured: 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
Measured: 7 days of CGM data
Mean of glucose levels
Mean in mg/dL of glucose levels obtained on rt-CGM
Measured: 7 days of CGM data
Standard deviation (SD) of glucose levels
Standard deviation (SD) in mg/dL of glucose levels obtained on rt-CGM
Measured: 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
Measured: 7 days of CGM data
HbA1c
Changes in HbA1C (post-study HbA1C minus pre-study HbA1C) and percentage of patients with HbA1C ≤7.0%
Measured: 12 weeks
Time to stable dose
The time (days) for patients to achieve target fasting glucose level and stable dose of iGlarLixiThe
Measured: 12 weeks
Treatment satisfaction questionnaire
Diabetes Treatment Satisfaction Questionnaire
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2022
- Study start28 Sep 2022
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MallyaStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, vghtpe user, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05591391
- Sponsor's protocol ID
- 2022-07-010B
- Status last verified
- Oct 2022
- First submitted
- 2 Oct 2022
- Last updated
- 24 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05591391
- Acronym / sponsor ID
- 2022-07-010B
- Conditions
- Mallya
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 28 Sep 2022 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 24 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mallya | Experimental | Other: Mallya capPatients use Mallya cap to record the time and dosage of insulin injection |
| Standard care | Active comparator | Other: Standard carePatients receive standard care. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mallya capAfter 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. | Other | Mallya |
| Standard careSuggestions regarding dose titration and glycemic control will be communicated by weekly telephone calls. | Other | Standard care |
Primary outcome
Time in range
Time frame: 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.
8 secondary outcomes
Time above range (TAR)
Time frame: 7 days of CGM data
Time below range (TBR)
Time frame: 7 days of CGM data
Mean of glucose levels
Time frame: 7 days of CGM data
Standard deviation (SD) of glucose levels
Time frame: 7 days of CGM data
Coefficient of variation (CV) of glucose levels
Time frame: 7 days of CGM data
HbA1c
Time frame: 12 weeks
Time to stable dose
Time frame: 12 weeks
Treatment satisfaction questionnaire
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2022.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mallya cap in people with Mallya, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chun-Jui Huang, PhD (0938590679, cjhuang3@vghtpe.gov.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range (time frame: 7 days of CGM data). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2022.