CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 11 enrolled
Drug / intervention
Liraglutide or Placebodrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02299388
NCT02299388Phase 4Completed

To Evaluate the Effect of Liraglutide on Ambulatory Blood Pressure-A Pilot Study

Tulane University School of Medicine·interventional·Posted Nov 24, 2014·Updated Jan 27, 2021

In Brief

A Phase 4 clinical trial evaluating Liraglutide or Placebo for Diabetes Mellitus, Non-Insulin-Dependent and Hypertensive Disease. Completed, enrolled 11 participants across 1 site.

Detailed Summary

The investigators are conducting this research to study the effect of Liraglutide on blood pressure. Several studies have shown increased cardiovascular complications and deaths in diabetics with hypertension. The importance of blood pressure control in diabetes has been shown in many clinical trials. No drug already approved for treating Type 2 Diabetes Mellitus is known to reduce blood pressure along with improving diabetes. However, prior research studies with liraglutide have suggested that treatment with liraglutide improves blood pressure. This effect is seen very quickly and even prior to any weight loss. The mechanism behind this effect is yet to be determined.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 4CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 24, 2014
Enrollment StartOct 1, 2014
Primary CompletionNov 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 11.6 years ago

Interventions

Liraglutide or Placebodrug

All subjects will be advised a low sodium diet. Eligible patients will have ABPM measurements and laboratory blood collection at baseline (prior to initiation of Liraglutide or Placebo), at 4 and 8 weeks of therapy. Patients will return 24 hours following ABPM placement for device and data retrieval.