CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 273 enrolled
Drug / intervention
Liraglutide + OADs +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/NCT01919489
NCT01919489Phase 4Completed

A Randomized Controlled Trial Comparing the Safety and Efficacy of Liraglutide Versus Glargine Insulin for the Management of Patients With Type 2 Diabetes After Hospital Discharge

Emory University·interventional·Posted Aug 9, 2013·Updated Nov 3, 2021

In Brief

A Phase 4 clinical trial evaluating Liraglutide + OADs and Glargine + OADs for Type 2 Diabetes. Completed, enrolled 273 participants across 5 sites.

Detailed Summary

High blood glucose levels in hospitalized patients with diabetes are associated with increased risk of medical complications and death. Improved glucose control with insulin injections may improve clinical outcome and prevent some of the hospital complications. Increasing evidence indicates that incretin-based agents are safe and effective for the hospital management of patients with type 2 diabetes (T2D). Liraglutide is a once-daily human glucagon-like peptide (GLP-1) analogue approved for the treatment of T2D. Liraglutide has been shown to lower blood glucose, stimulate endogenous insulin secretion, decrease plasma glucagon levels, inhibit gastric emptying, reduce food intake and body weight and improve ß-cell function when administered subcutaneously. Liraglutide increases insulin secretion in a glucose-dependent manner (i.e., only when plasma glucose levels are elevated), resulting in low-risk of hypoglycemia when used as monotherapy. When compared to insulin glargine therapy, the use of GLP-1 has resulted in comparable reduction in HbA1c level, lower rates of hypoglycemia and less weight gain. No prospective studies; however, have compared the efficacy and safety of liraglutide in the hospital setting or after hospital discharge. The primary objective is to compare the safety and efficacy of liraglutide (Victoza®) versus glargine insulin in combination to oral anti-diabetic agents (OADs: metformin, sulfonylureas, nateglinide, repaglinide or pioglitazone) on glycemic control after 26 weeks of treatment in medicine patients with T2D after hospital discharge.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedAug 9, 2013
Enrollment StartMar 1, 2014
Primary CompletionAug 30, 2020
TodayJul 2, 2026
Enrollment to primary: 6.5 yearsPosted 12.9 years ago

Interventions

Liraglutide + OADsdrug

Liraglutide subcutaneously daily

Glargine + OADsdrug

Glargine once daily subcutaneously