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Triple Therapy in T1DM
Triple Therapy for Type 1 Diabetes With Insulin, Semaglutide, and Dapagliflozin
Lead sponsor
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 ≥25•HbA1c ≥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
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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
Weight & body composition
3 endpointsbody weight assessment following dapagliflozin
Time frame:6 months
Body weight, absolute change (kg)
change from baseline, improvement
body weight assessment following semaglutide
Time frame:6 months
Body weight, absolute change (kg)
change from baseline, improvement
body weight assessment following triple therapy
Time frame:12 months
Body weight, absolute change (kg)
change from baseline, improvement
Glycemic / diabetes
11 endpointsChange in HbA1c following dapagliflozin
Time frame:6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c with triple therapy
Time frame:12 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Change in HbA1c with semaglutide
Time frame:6 months
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Assessment of hyperglycemia level 1
Time frame:12 months
CGM time-above-range
percent change from baseline, improvement
Assessment of hyperglycemia level 2
Time frame:12 months
CGM time-above-range
percent change from baseline, improvement
Assessment of percent time glucose in range
Time frame:12 months
CGM time-in-range
percent change from baseline, improvement
Fructosamine indices
Time frame:12 months
change from baseline, improvement
Weekly fasting glucose indices
Time frame:12 months
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Insulin requirement indices
Time frame:12 months
change from baseline, improvement
Level 1 hyperglycemia assessment
Time frame:12 months
CGM time-above-range
event count, improvement
Level 2 hyperglycemia assessment
Time frame:12 months
threshold achievement, event
Cardiometabolic biomarkers
3 endpointsSystolic Blood pressure assessment after triple therapy
Time frame:12 months
Systolic BP, change
change from baseline, improvement
LOINC 8480-6
Diastolic Blood pressure assessment
Time frame:12 months
Diastolic BP, change
change from baseline, improvement
LOINC 8462-4
Blood pressure medication use
Time frame:12 months
change from baseline, improvement
Safety / tolerability / PK
6 endpointsAssessment of hypoglycemia
Time frame:12 months
Documented hypoglycemia
percent change from baseline, event
Level 2 hypoglycemia assessment
Time frame:12 months
Documented hypoglycemia
event count, event
Severe (level 3) hypoglycemia assessment
Time frame:12 months
Severe hypoglycemia
event count, event
serum ketones assessment
Time frame:12 months
threshold achievement, event
Urinary ketones assessment
Time frame:12 months
threshold achievement, event
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
- Diabetes, obesity & metabolism2025 Sep (month)PMID40555701doi:10.1111/dom.16519via pubmed nct search
Provenance
Sources
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.