DelfaGLP-1 Atlas

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CompletedPhase 4

Post-Marketing Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of Ipragliflozin in Combination With GLP-1 Receptor Agonists in Japanese Patients With Type 2 Diabetes Mellitus (T2DM)

Postmarketing Clinical Study of Ipragliflozin - Long-term Study in Combination With GLP-1 Receptor Agonists in Patients With Type 2 Diabetes Mellitus

Asset

GLP-1 / incretin class catch-all

Listed sites

6

Recruiting sites

—

Enrollment

100

actual

Study population

Type 2 diabetes

Key I/E criteria

•BMI ≥20•HbA1c ≥7.5%

Primary endpoints

•HbA1c, change•Fasting glucose, change

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 IDNCT02291874
Org study ID1941-CL-0132

Timeline

Milestones

Study start2014-10-08actual
Study first posted2014-11-17estimated
Primary completion2016-07-07actual
Study completion2016-07-07actual
Last update posted2024-11-08actual

Assets

Investigational agents

GLP-1 / incretin class catch-all

Study populations

Who this study enrolls

Type 2 diabetes

Eligibility

Who can enroll

Minimum age20 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

•The subject has a diagnosis of T2DM that was determined at least 12 weeks (84 days) before providing informed consent.
•The subject has been receiving the same GLP-1 receptor agonist at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit 1.
•If on therapy with a concomitant SU, the subject has been receiving the same SU at a fixed dose and mode of administration for at least 6 weeks (42 days) prior to Visit 1.
•The subject has HbA1c levels of ≥7.5% but ≤10.5% at Visit 2, and the difference in HbA1c levels between Visit 1 and Visit 2 is within ±1.0%.
•The subject has a BMI of ≥20.0 kg/m2 but ≤45.0 kg/m2 at Visit 2.
•If on therapy with a concomitant SU, the subject has fasting plasma glucose levels of ≥126 mg/dL at Visit 2.

Exclusion criteria

•The subject has T1DM.
•The subject has symptoms of dysuria, anuria, oliguria, or urinary retention.
•The subject has proliferative retinopathy.
•The subject has a history of clinically significant renal diseases such as renovascular occlusive disease, nephrectomy, or renal transplant.
•The subject has a history of pancreatitis.
•The subject has a history of recurrent urinary tract infections (≥3 episodes within 24 weeks before providing informed consent).
•The subject has a symptomatic urinary tract infection or symptomatic genital infection.
•The subject has a chronic disease that requires the continuous use of adrenocortical steroids and immunosuppressants (oral, injectable, or inhalational medications).
•The subject has a history of cerebral vascular attack, unstable angina, myocardial infarction, vascular intervention, or serious heart disease (NYHA Class III-IV) within 1 year (52 weeks) prior to Visit 1, or the subject has heart disease or cerebral vascular disease that, as per the judgment of the investigator or sub-investigator, may interfere with the treatment with ipragliflozin or safety evaluation of this study.
•The subject has an unstable psychiatric disorder.
•The subject is a female who is currently pregnant or lactating or could be pregnant.
•The subject is unable or unwilling to practice an appropriate contraception method during the study.
•The subject has severe infection, perioperative or serious trauma.
•The subject has drug addiction or abuses alcohol.
•The subject has a history of malignant tumors (except when he/she has been free from treatment for at least 5 years before providing informed consent and is not considered to have any recurrence).
•The subject has a history of allergy to ipragliflozin or similar drugs that have an SGLT2 inhibitory action.
•The subject has participated in a clinical study of an investigational product or medical device or post-marketing study within 12 weeks (84 days) before providing informed consent or is currently participating in any of these studies.
•The subject is unable or unwilling, or does not agree, to comply with the study requirements, including the hospital visits, dose instructions, and the subject's responsibilities.

Endpoints (11)

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
5
Weight & body composition
2
Cardiometabolic biomarkers
2
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Body weight

Time frame:0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

5 endpoints
Primary/protocol endpoint

HbA1c

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Primary/protocol endpoint

Fasting plasma glucose

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting serum insulin

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

concentration, descriptive

Secondary/protocol endpoint

Serum glycoalbumin

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

change from baseline, improvement

Secondary/protocol endpoint/low confidence

Self-measured blood glucose

Time frame:at 0, 20, 52-week

descriptive

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Serum leptin

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

Leptin, change

change from baseline, improvement

Secondary/protocol endpoint

Serum adiponectin

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

Adiponectin, change

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Adverse events (AEs), vital signs, and laboratory tests

Time frame:All treatment period

descriptive

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Serum glucagon

Time frame:at 0, 2, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52-week

descriptive

Publications (1)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

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.