NCT03899402

Triple Therapy in T1DM

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

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: State University of New York at Buffalo · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This will be a 52 week study for type 1 diabetics looking into the effect of semaglutide and dapagliflozin on HbA1c and glycemic control.

Conditions

• Type 1 Diabetes Mellitus

Interventions

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

Timeline

• Start date: 2019-05-01
• Primary completion: 2026-01-31
• Completion: 2026-03-31
• First posted: 2019-04-02
• Last updated: 2025-04-02

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study