Renal Effects of Treatment With Empagliflozin Alone or in Combination With Semaglutide in Patients With Type 2 Diabetes and Albuminuria

PHASE4UnknownINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

November 1, 2019

Primary Completion Date

July 1, 2021

Study Completion Date

August 1, 2021

Conditions
Type 2 Diabetes With Renal Manifestations
Interventions
DRUG

Semaglutide, 1.34 mg/mL

After informed consent, subjects will be initiated on open-label empagliflozin 25 mg or maximal tolerated dosis once daily during a run-in period of 26 weeks. Participants will be randomized and up titrated to semaglutide 1.34 mg/ml or matching placebo once weekly during the following 26 weeks in a 1:1 ratio.

OTHER

Placebo, 1,34 mg/mL

Participants will be randomised to either semaglutide or placebo as an add on treatment after 26 weeks of intervention with empagliflozin 25 mg.

DRUG

Empagliflozin 25 MG

After informed consent, subjects will be initiated on open-label empagliflozin 25 mg or maximal tolerated dosis once daily during a run-in period of 26 weeks.

Trial Locations (1)

2820

Steno Diabetes Center Copenhagen, Gentofte Municipality

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novo Nordisk A/S

INDUSTRY

lead

Steno Diabetes Center Copenhagen

OTHER