CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 71 enrolled
Drug / intervention
Liraglutide +1 moredrug
Likely dose
Liraglutide 1.8mgfrom 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/NCT01505673
NCT01505673Phase 4Completed
CompareCT.gov

Adding Liraglutide to High Dose Insulin: Breaking the Cycle

Ildiko Lingvay·interventional·Posted Jan 6, 2012·Updated Jan 16, 2018

In Brief

A Phase 4 clinical trial evaluating Liraglutide and Saline for Type 2 Diabetes Mellitus and Obesity. Completed, enrolled 71 participants across 1 site.

Detailed Summary

The purpose of this study is to evaluate whether the addition of liraglutide 1.8 mg/day to a high-dose insulin regimen (\>1.8 units/kg/day) in patients with uncontrolled (HbA1c \>7.5%) type 2 diabetes mellitus will improve blood sugar control. It also evaluates the effect of liraglutide on liver and pancreatic fat content, explores the mechanism of blood sugar improvement by assessing weight and pancreatic hormone release, and assesses blood pressure, lipid profile, and liver function. Finally it will look at patient quality of life and safety.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus, Obesity
CountriesUnited States
CollaboratorsNovo Nordisk A/S

Timeline

Phase 4CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJan 6, 2012
Enrollment StartJan 1, 2012
Primary CompletionJun 1, 2016
TodayJul 2, 2026
Enrollment to primary: 4.4 yearsPosted 14.5 years ago

Interventions

Liraglutidedrug

Liraglutdie 1.8mg injected subcutaneously from pen device once daily for 6-months

Salinedrug

Placebo injection of 1.8mg saline once daily for 6-months