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SAFEGUARD: Pleiotropic Effects of Incretin Based Therapies

NCT01744236 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2015-12-09

No results posted yet for this study

Summary

The aim of this study is to detail the (mechanisms underlying the) actions of the GLP-1 receptor agonists and DPP-4 inhibitors on the cardiovascular, renal and gastrointestinal systems in patients with Type 2 Diabetes Mellitus.

Conditions

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

Sponsors & Collaborators

  • EU FP7: SAFEGUARD consortium

    collaborator UNKNOWN

  • Amsterdam UMC, location VUmc

    lead OTHER

Principal Investigators

  • M.H.H. Kramer, MD PhD · Amsterdam UMC, location VUmc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-04-30
Primary Completion
2015-08-31
Completion
2015-08-31

Countries

  • Netherlands

Study Locations

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Entities

Drugs
Diseases

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 NCT01744236 on ClinicalTrials.gov