SAFEGUARD: Pleiotropic Effects of Incretin Based Therapies

PHASE4CompletedINTERVENTIONAL
Enrollment

70

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

August 31, 2015

Conditions
Type 2 Diabetes
Interventions
DRUG

Liraglutide

Liraglutide will be started with a titration period of 2 weeks (week 1: 0.6mg once daily and week 2: 1.2mg once daily). If liraglutide is well tolerated it will be continued for 10 more weeks in a dosage of 1.8mg once daily.

DRUG

Sitagliptin

Sitagliptin 100mg will be given once daily for 12 weeks.

DRUG

Exenatide

Exenatide will be administered intravenously with a loading dose of 50ng/min for 30 minutes, followed by a maintenance dose of 25ng/min during the rest of the tests

DRUG

Liraglutide placebo

Liraglutide-placebo will be started with a titration period of 2 weeks (week 1: 0.6mg once daily and week 2: 1.2mg once daily). It will be continued for 10 more weeks in a dosage of 1.8mg once daily.

DRUG

Sitagliptin placebo

Sitagliptin-placebo be given once daily for 12 weeks.

DRUG

Exenatide placebo

Exenatide-placebo (saline) will be administered intravenously

DRUG

L-NMMA

Trial Locations (1)

1081HV

VU University Medical Center, Amsterdam

All Listed Sponsors
collaborator

EU FP7: SAFEGUARD consortium

UNKNOWN

lead

Amsterdam UMC, location VUmc

OTHER

NCT01744236 - SAFEGUARD: Pleiotropic Effects of Incretin Based Therapies | Biotech Hunter | Biotech Hunter