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Triple Therapy in T1DM

NCT03899402 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 78

Last updated 2025-04-02

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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

Sponsors & Collaborators

  • University of Glasgow

    collaborator OTHER

  • Juvenile Diabetes Research Foundation

    collaborator OTHER

  • State University of New York at Buffalo

    lead OTHER

Principal Investigators

  • Husam Ghanim, PhD · State University of NY at Buffalo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-01
Primary Completion
2026-01-31
Completion
2026-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03899402 on ClinicalTrials.gov