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

NCT05591391 | Unknown

• 1 other identifier: 2022-07-010B
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Mallya

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Time above range (TAR)

  7 days of CGM data

• Time below range (TBR)

  7 days of CGM data

• Mean of glucose levels

  7 days of CGM data

• Standard deviation (SD) of glucose levels

  7 days of CGM data

• Coefficient of variation (CV) of glucose levels

  7 days of CGM data

Study Arms (2)

Mallya

EXPERIMENTAL

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

Other: Mallya cap

Standard care

ACTIVE COMPARATOR

Patients receive standard care.

Other: Standard care

Interventions

Mallya cap OTHER

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.

Mallya

Standard care OTHER

Suggestions regarding dose titration and glycemic control will be communicated by weekly telephone calls.

Standard care

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Division of Endocrinology and Metabolism, Department of Medicine, Taipei Veterans General Hospital

Taipei, Taiwan

RECRUITING

MeSH Terms

Interventions

Standard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Chun-Jui Huang, PhD

CONTACT

0938590679; cjhuang3@vghtpe.gov.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attetnding Physician, Department of Endocrinology and Metabolism, Principal Investigator, Doctor of Philosophy, Associate Professor

Study Record Dates

• First Submitted: October 2, 2022
• First Posted: October 24, 2022
• Study Start: September 28, 2022
• Primary Completion: June 30, 2025
• Study Completion: June 30, 2025
• Last Updated: October 24, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)