DelfaGLP-1 Atlas

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UnknownPhase NA

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

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

Asset

Lixisenatide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

40

estimated

Study population

Type 2 diabetes

Key I/E criterion

•HbA1c ≥7%

Primary endpoint

•CGM time-in-range

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05591391
Org study ID2022-07-010B

Timeline

Milestones

Study start2022-09-28actual
Study first posted2022-10-24actual
Last update posted2022-10-24actual
Primary completion2025-06-30estimated
Study completion2025-06-30estimated

Assets

Investigational agents

Lixisenatide

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
SexAll
Healthy volunteersNot accepted

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.

Endpoints (9)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Glycemic / diabetes
8
Patient-reported / QoL
1

Glycemic / diabetes

8 endpoints
Primary/protocol endpoint

Time in range

Time frame:7 days of CGM data

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Time above range (TAR)

Time frame:7 days of CGM data

CGM time-above-range

threshold achievement, improvement

Secondary/protocol endpoint

Time below range (TBR)

Time frame:7 days of CGM data

CGM time-below-range

percent change from baseline, improvement

Secondary/protocol endpoint/low confidence

Mean of glucose levels

Time frame:7 days of CGM data

descriptive, improvement

Secondary/protocol endpoint/low confidence

Standard deviation (SD) of glucose levels

Time frame:7 days of CGM data

descriptive

Secondary/protocol endpoint

Coefficient of variation (CV) of glucose levels

Time frame:7 days of CGM data

descriptive

Secondary/protocol endpoint

HbA1c

Time frame:12 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint/low confidence

Time to stable dose

Time frame:12 weeks

time to event, improvement

Patient-reported / QoL

1 endpoint
Secondary/protocol endpoint

Treatment satisfaction questionnaire

Time frame:12 weeks

descriptive, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 1, 2026
Endpoint classificationDelfa endpoint taxonomy v2 (May 13, 2026)
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.