Triple Therapy in T1DM

Part of paid clinical trials in Williamsville, New York.

Sponsor
State University of New York at Buffalo
Study ID
NCT03899402
Phase
PHASE2/PHASE3
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Insulin — DRUG
    Standard of care insulin for pump or injection and serves as a control
  • Semaglutide — DRUG
    Injectable weekly GLP-1RA given as open label experimental drug
  • Dapagliflozin — DRUG
    Oral daily SGLT2 Inhibitor given as experimental drug
  • Placebo to Dapagliflozin — DRUG
    Placebo to Dapagliflozin given as a control to the experimental drug

Study Details

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.

Key Dates

Start date
May 1, 2019
Status verified
May 2026
Primary completion
Jan 31, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
78 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control
    Standard of care insulin will be used as an active comparator arm for 1/3 of patients (38 patients) for the entire duration of the study.
  • Experimental: Dual Therapy
    Once a week injection of Semaglutide (a GLP-1 receptor agonist) in addition to standard of care insulin for the first six months in 2/3 of patients (76 patients). Semaglutide is a clear, colorless solution that contains 2 mg of semaglutide in a 1.5 mL (1.34 mg/mL) pre-filled, disposable, single-patient-use pen injector. Semaglutide will be started at the 0.25 mg dose for the first two weeks, then increased to 0.5 mg at week 2, and then yet again increased to 1.0 mg at week 4.
  • Experimental: Triple therapy
    Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of Dapagliflozin (an SGLT-2 inhibitor) added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)). Dapagliflozin will be started at 5 mg for one week, and then increased to 10 mg for the remainder of the study
  • Placebo Comparator: Triple therapy control
    Once a day oral pill (green, plain, diamond shaped film coated 5 mg tablet) of the Placebo form of Dapagliflozin added to once a week injection of semaglutide and standard of care insulin in the second 6 months of 1/2 of the dual therapy arm (1/3 of total patients (38 patients)).

Primary Outcome Measure

Change in HbA1c following dapagliflozin [ Time Frame: 6 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Diabetes and Endocrinology Research Center of WNYWilliamsvilleNew York14221-

Find similar trials in Williamsville, NY

By condition
Type 1 diabetes
By specialty
Endocrinology
By research site
Diabetes and Endocrinology Research Center of WNY· Williamsville, NY

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