Active — Not RecruitingPhase 2/3

Triple Therapy in T1DM

United States78 participantsStarted 2019-05-01

Plain-language summary

To assess whether the addition of dapagliflozin to semaglutide and insulin (triple therapy) improves glycemic control in patients with type 1 diabetes compared with semaglutide and insulin (dual therapy) and insulin only (standard) treatment.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. 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.
✓. C-peptide \<0.23 nM
✓. Minimum dose of insulin in Units/kg at entry: 0.5 U/kg for MDI and 0.4 U/kg for CSII
✓. Regularly measuring blood sugars four or more times daily.
✓. HbA1c of \>7.5%.
✓. Well versed in CHO counting\*
✓. Age 18-70 years.
✓. BMI ≥25 kg/m2.

Exclusion criteria

✕. Type 1 diabetes for less than 12 months, type 2 diabetes, chronic pancreatitis, MODY
✕. Previous use of any agent other than insulin for treatment of diabetes in the last 3 months.
✕. History of diabetic ketoacidosis (DKA) requiring medical intervention (e.g., emergency room visit and/or hospitalization) within 3 month prior to the screening visit
✕. 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
✕. Symptoms of poorly controlled diabetes that would preclude participation in this trial
✕. Subjects on a commercial weight loss program with ongoing weight loss, or on an intensive exercise program
✕. History of bariatric surgery or lap-band procedure within 12 months prior to screening
✕. History of Addison's disease or chronic adrenal insufficiency

What they're measuring

Change in HbA1c following dapagliflozin

Timeframe: 6 months

Trial details

NCT IDNCT03899402

SponsorState University of New York at Buffalo

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-01-31

View on ClinicalTrials.gov More Type 1 Diabetes Mellitus trials