CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 124 enrolled
Drug / intervention
Liraglutide +1 moredrug
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/NCT02113332
NCT02113332Phase 2Completed

Addition of Liraglutide to Overweight Patients With Type 2 Diabetes Treated With Multiple Daily Insulin Injections (MDI) With Inadequate Glycaemic Control

Vastra Gotaland Region·interventional·Posted Apr 14, 2014·Updated Feb 3, 2015

In Brief

A Phase 2 clinical trial evaluating Liraglutide and Placebo for Type 2 Diabetes Mellitus. Completed, enrolled 124 participants across 14 sites.

Detailed Summary

Liraglutide, a GLP-1-analogue has been shown to be an effective treatment option in patients on oral anti-diabetes therapy with beneficial effects on both glycaemic control and weight. However, to date there are no clinical trials of liraglutide added to insulin therapy, a population of patients generally having worse glycaemic control and weight gain. In clinical guidelines, use of multiple daily insulin injections (MDI) is usually the final therapeutic option for type 2 diabetic patients. The primary study aim is to evaluate whether the addition of liraglutide, compared to placebo, reduces the HbA1c level for overweight and obese type 2 diabetes patients with inadequate glycaemic control treated with multiple daily insulin injections (MDI). MDI is defined as treatment with any basal insulin combined with separate meal time insulin injections before the main meals, i.e. an insulin regimen with premixed insulin is not considered as MDI. The planned study duration is 24 weeks and includes 120 patients at 15 centers in Sweden.

Study Details

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

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedApr 14, 2014
Enrollment StartJan 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 12.2 years ago

Interventions

Liraglutidedrug

Placebodrug