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Active not recruitingPhase 2, PHASE3

Triple Therapy in T1DM

Triple Therapy for Type 1 Diabetes With Insulin, Semaglutide, and Dapagliflozin

Asset

Semaglutide

GLP-1 agonist

Listed sites

1

Recruiting sites

Enrollment

78

actual

Study population

Obesity / overweight, Type 1 diabetes

Key I/E criteria

BMI ≥25HbA1c ≥7.5%

Primary endpoint

HbA1c, 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 IDNCT03899402
Org study IDSTUDY00002775
Secondary ID1987Diabetes and Endocrinology Research Foundation

Timeline

Milestones

Study first posted2019-04-02actual
Study start2019-05-01actual
Primary completion2026-01-31actual
Last update posted2026-05-29actual
Study completion2026-06-30estimated

Assets

Investigational agents

Study populations

Who this study enrolls

Obesity / overweightType 1 diabetes

Eligibility

Who can enroll

Minimum age18 Years
Maximum age75 Years
SexAll
Healthy volunteersNot accepted

Inclusion criteria

1. Type 1 Diabetes for at least 1 year on staple use of continuous subcutaneous insulin infusion (CSII) or multiple daily (four or more) injections (MDI) of insulin for last 3 months.

2. C-peptide <0.23 nM

3. Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII

4. Regularly measuring blood sugars four or more times daily.

5. HbA1c of >7.5%.

6. Well versed in CHO counting*

7. Age 18-70 years.

8. BMI ≥25 kg/m2.

Exclusion criteria

1. Type 1 diabetes for less than 12 months, type 2 diabetes, chronic pancreatitis, MODY

2. Previous use of any agent other than insulin for treatment of diabetes in the last 3 months.

3. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to the screening visit

4. Frequent episodes of severe hypoglycemia as defined by more than one episode requiring medical assistance, emergency care (paramedics or emergency room care), and/or glucagon therapy administered by a third-party individual within 1 month prior to the screening visit

5. Symptoms of poorly controlled diabetes that would preclude participation in this trial

6. Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program

7. History of bariatric surgery or lap-band procedure within 12 months prior to screening

8. History of Addison's disease or chronic adrenal insufficiency

9. History of diabetes insipidus

10. Hepatic disease or cirrhosis with Aspartate Aminotransferase (AST) > 3X Upper limit of normal (ULN) and/or Alanine aminotransferase (ALT) > 3X ULN

11. Serum Total Bilirubin > 2X ULN unless exclusively caused by Gilbert's Syndrome

12. Hemoglobin < 11.0 g/dL (110 g/L) for men; hemoglobin < 10.0 g/dL (100 g/L) for women.

13. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass, surgery or coronary angioplasty) in the previous 3 months or patients with congestive heart failure.

14. ESRD on hemodialysis; and or e-GFR < 60 ml/min/1.73m2

15. HIV or Hepatitis B/C positive status

16. Any other life-threatening, noncardiac disease

17. History of pancreatitis

18. Women who are pregnant or women of childbearing potential who are not using adequate contraception or who are breast feeding

19. Inability to give informed consent

20. History of gastroparesis

21. History of medullary thyroid carcinoma or MEN 2 syndrome

22. History of serious hypersensitivity reaction to these agents

23. Painful gallstones

24. Alcoholism

25. Hypertriglyceridemia (>500 mg/dl)

26. Recurrent genital mycotic infection.

27. Hypovolemic patients or with chronic renal insufficiency.

28. Patients with any malignancy except treated in situ malignancy and basal cell carcinoma of the skin

29. Unexplained hematuria

30. Patients with a history of diabetic retinopathy

31. Use of an investigational agent or therapeutic regimen within 30 days of study

32. Participation in any other concurrent interventional clinical trial

Endpoints (23)

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
11
Safety / tolerability / PK
6
Weight & body composition
3
Cardiometabolic biomarkers
3

Weight & body composition

3 endpoints
Secondary/protocol endpoint

body weight assessment following dapagliflozin

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

body weight assessment following semaglutide

Time frame:6 months

Body weight, absolute change (kg)

change from baseline, improvement

Secondary/protocol endpoint

body weight assessment following triple therapy

Time frame:12 months

Body weight, absolute change (kg)

change from baseline, improvement

Glycemic / diabetes

11 endpoints
Primary/protocol endpoint

Change in HbA1c following dapagliflozin

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c with triple therapy

Time frame:12 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Change in HbA1c with semaglutide

Time frame:6 months

HbA1c, change

change from baseline, improvement

LOINC 4548-4

Secondary/protocol endpoint

Assessment of hyperglycemia level 1

Time frame:12 months

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Assessment of hyperglycemia level 2

Time frame:12 months

CGM time-above-range

percent change from baseline, improvement

Secondary/protocol endpoint

Assessment of percent time glucose in range

Time frame:12 months

CGM time-in-range

percent change from baseline, improvement

Secondary/protocol endpoint

Fructosamine indices

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Weekly fasting glucose indices

Time frame:12 months

Fasting glucose, change

change from baseline, improvement

LOINC 1558-6

Secondary/protocol endpoint/low confidence

Insulin requirement indices

Time frame:12 months

change from baseline, improvement

Secondary/protocol endpoint

Level 1 hyperglycemia assessment

Time frame:12 months

CGM time-above-range

event count, improvement

Secondary/protocol endpoint/low confidence

Level 2 hyperglycemia assessment

Time frame:12 months

threshold achievement, event

Cardiometabolic biomarkers

3 endpoints
Secondary/protocol endpoint

Systolic Blood pressure assessment after triple therapy

Time frame:12 months

Systolic BP, change

change from baseline, improvement

LOINC 8480-6

Secondary/protocol endpoint

Diastolic Blood pressure assessment

Time frame:12 months

Diastolic BP, change

change from baseline, improvement

LOINC 8462-4

Secondary/protocol endpoint

Blood pressure medication use

Time frame:12 months

change from baseline, improvement

Safety / tolerability / PK

6 endpoints
Secondary/protocol endpoint

Assessment of hypoglycemia

Time frame:12 months

Documented hypoglycemia

percent change from baseline, event

Secondary/protocol endpoint

Level 2 hypoglycemia assessment

Time frame:12 months

Documented hypoglycemia

event count, event

Secondary/protocol endpoint

Severe (level 3) hypoglycemia assessment

Time frame:12 months

Severe hypoglycemia

event count, event

Secondary/protocol endpoint

serum ketones assessment

Time frame:12 months

threshold achievement, event

Secondary/protocol endpoint

Urinary ketones assessment

Time frame:12 months

threshold achievement, event

Secondary/protocol endpoint

Diabetic ketoacidosis assessment

Time frame:12 months

event count, event

Publications (2)

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.