DelfaGLP-1 Atlas

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SEMPA

RecruitingPhase 3

A Clinical Trial to Evaluate The Effects of Semaglutide and Empagliflozin Combined to Automated Insulin Delivery on Diabetes Control in Adults Living With Type 1 Diabetes

Semaglutide And Empagliflozin Combination Therapy Added To Automated Insulin Delivery In Adults With Type 1 Diabetes (SEMPA)

Asset

Semaglutide

Subcutaneous · GLP-1 agonist

Listed sites

1

Recruiting sites

1

Enrollment

36

estimated

Study population

Type 1 diabetes

Key I/E criterion

•BMI ≥23

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 IDNCT06894784
Org study ID2025-10723

Timeline

Milestones

Study first posted2025-03-25actual
Last update posted2025-03-30actual
Study start2025-04estimated (month precision)
Primary completion2027-01estimated (month precision)
Study completion2027-01estimated (month precision)

Assets

Investigational agents

Semaglutide

Study populations

Who this study enrolls

Type 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Eligibility criteria

The inclusion criteria at the time of enrollment are:

•Males and females aged 18 or older.
•Clinical diagnosis of T1D for at least one year.
•Use of AID system for at least three months.
•Body Mass Index (BMI) ≥ 23 kg/m2.

The exclusion criteria are:

•Use of GLP1-RA within one month of admission.
•Use of SGLT2i within two weeks of admission.
•Planned or ongoing pregnancy.
•Breastfeeding.
•Severe hypoglycemic episode within three months of admission (defined as an event where blood glucose levels were < 4.0 mmol/L, resulting in seizure, loss of consciousness, or the need to present to the emergency department).
•Diabetic ketoacidosis episode within six months of admission.
•History of acute pancreatitis, chronic pancreatitis, or gallbladder disease.
•Personal or family history of medullary thyroid cancer or multiple endocrine neoplasia type 2.
•Severe impairment of renal function with an eGFR < 30 mL/min/1.73 m2 within four months of admission. eGFR will be computed using the CKD-EPI method.
•Clinically significant diabetic retinopathy or gastroparesis, as per the investigator's judgement.
•Bariatric surgery within six months of admission.
•A serious medical or psychiatric illness that would likely interfere with participation in this study, as per the investigator's judgement.
•Inability or unwillingness to comply with safe diabetes management practices, as per the investigator's judgment.

Endpoints (13)

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
10
Patient-reported / QoL
2
Other (unclassified)
1

Glycemic / diabetes

10 endpoints
Primary/protocol endpoint

Time-in-Range

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Overall Time In Range

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Optimal Time In Range

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

CGM time-in-range

descriptive, improvement

Secondary/protocol endpoint

Time In Hypoglycemia

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

CGM time-below-range

descriptive, improvement

Secondary/protocol endpoint

Time In Mild Hyperglycemia

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Time Above Range

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

CGM time-above-range

descriptive, improvement

Secondary/protocol endpoint

Time In Severe Hyperglycemia

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Total Insulin dose

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

descriptive

Secondary/protocol endpoint

Basal insulin dose

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

descriptive

Secondary/protocol endpoint

Bolus insulin dose

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

descriptive

Patient-reported / QoL

2 endpoints
Secondary/protocol endpoint

Patient-reported outcomes

Time frame:At the end of each intervention at weeks 16, 21, 29, 34

descriptive, improvement

Secondary/protocol endpoint

Patient-reported outcomes

Time frame:At the end of each intervention at weeks 16, 21, 29, 34

descriptive, improvement

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Carbohydrate intake

Time frame:At days 7, 35, 63 of the titration period and days 3 and 7 of each intervention.

descriptive

Publications (33)

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.