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TerminatedPhase 4

Comparison of Oral Semaglutide w/ Placebo- Treatment for Latino Adults w/T2 Diabetes Receiving Enhanced Lifestyle Care

Comparison of Oral Semaglutide With Matched Oral Semaglutide Placebo as an Early Treatment for Latino Adults With Type 2 Diabetes Receiving Enhanced Lifestyle Care

Asset

Semaglutide

Oral · GLP-1 agonist

Listed sites

1

Recruiting sites

-

Actual enrollment

12

Study population

Type 2 diabetes

Eligibility highlights

HbA1c 7.5-10%

Primary endpoint

HbA1c <7.0% achievement

Registered trial locations

Locations reported to ClinicalTrials.gov for this trial snapshot. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT04938388
Org study IDU1111-1238-3149

Timeline

Milestones

Study first posted2021-06-24actual
Study start2022-01-29actual
Primary completion2023-02-16actual
Study completion2023-02-16actual
Last update posted2023-05-25actual

Assets

Investigational agents

Who this study enrolls

Type 2 diabetes

Who can enroll

Minimum age18 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Individuals ≥ 18 years of age at enrollment.

2. Self-reported Hispanic/Latino heritage.

3. Established diagnosis of T2D for at least 3 months prior to enrollment date.

4. HbA1c > 7.5% and ≤ 10.0% (58-86 mmol/mol) within the previous 6 months.

5. T2D treated with lifestyle alone or lifestyle + Metformin within the past 6 months prior to screening.

6. Ability to provide informed consent before any trial-related activities. Trial-related activities are any procedure that would not have been performed during normal management of the subject.

7. Based on the research staff's judgment, participant or participant's representative must have a good understanding, ability, and willingness to adhere to the protocol, including performance of self-monitored data collection during the wearable device portion of the study.

Exclusion criteria

1. Type 1 diabetes or a history of diabetic ketoacidosis.

2. T2D treated with oral medicines other than Metformin or any injectable GLP-1 receptor agonist or insulin within the past 6 months prior to screening.

3. Life expectancy < 12 months.

4. Any active clinically significant physical or mental disease or disorder which, in the investigator's opinion, could interfere with the participation in the study.

5. History of major surgical procedures involving the stomach potentially affecting absorption of trial product (e.g., subtotal and total gastrectomy, sleeve gastrectomy, gastric bypass surgery).

6. Untreated pre-proliferative or proliferative retinopathy or maculopathy due to diabetes.

7. Renal impairment, defined as estimated glomerular filtration rate <30 mL/min/1.73 m2.

8. Personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia syndrome type 2.

9. Language barriers precluding comprehension of study activities and informed consent.

10. Participation in other research studies involving medication or device within 1 month prior to enrollment.

11. Known or suspected abuse of alcohol, narcotics, or illicit drugs.

12. Known or suspected allergy to OS, excipients, or related products.

13. Previous participation in this trial whether screened or randomized.

14. Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures.

15. The receipt of any investigational drug (within 12 months) prior to this trial.

Endpoints (14)

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
7
Weight & body composition
2
Cardiometabolic biomarkers
2
MASH / liver
1
Safety / tolerability / PK
1
Other (unclassified)
1

Weight & body composition

2 endpoints
Secondary/protocol endpoint

Weight

Time frame:At 50 weeks

change from baseline, improvement

Secondary/protocol endpoint

Waist circumference

Time frame:At 50 weeks

Waist circumference, change

change from baseline, improvement

Glycemic / diabetes

7 endpoints
Primary/protocol endpoint

HbA1c < 7.0%

Time frame:At 50 weeks

HbA1c <7.0% achievement

threshold achievement, improvement

LOINC 4548-4

Secondary/protocol endpoint

HbA1c

Time frame:At 50 weeks

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Fasting glucose levels

Time frame:At 50 weeks

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint

Fasting insulin levels

Time frame:At 50 weeks

change from baseline, improvement

Secondary/protocol endpoint

Calculation of insulin resistance (HOMA-B and HOMA-IR)

Time frame:At 50 weeks

HOMA-IR (insulin sensitivity)

change from baseline, improvement

Secondary/protocol endpoint

CGM Time In Range

Time frame:Weeks 48-49

CGM time-in-range

change from baseline, improvement

Secondary/protocol endpoint

Additional glucose-lowering medication (rescue medication)

Time frame:Comparison at 4, 8, 22, 34, and 48 weeks

categorical status, event

MASH / liver

1 endpoint
Secondary/protocol endpoint

Liver Function Test

Time frame:Comparison with baseline (-2 weeks) and at 50 weeks

change from baseline, improvement

Cardiometabolic biomarkers

2 endpoints
Secondary/protocol endpoint

Lying and standing blood pressure

Time frame:At 50 weeks

change from baseline, improvement

Secondary/protocol endpoint

Lipid Levels

Time frame:Comparison with baseline (-2 weeks) and at 50 weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint
Secondary/protocol endpoint

Number of participants with treatment-related adverse events assessed by research physician classified according to Good Clinical Practice guidelines

Time frame:Data captured at baseline

Treatment-emergent AEs (any)

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

Number of Pill Counts

Time frame:Comparison at 4, 8, 22, 34, and 48 weeks

descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 6, 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 6, 2026 snapshot.