Liraglutide Hospital Discharge Trial

Part of paid clinical trials in Miami, Florida.

Sponsor
Emory University
Study ID
NCT01919489
Phase
PHASE4
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Liraglutide + OADs — DRUG
    Liraglutide subcutaneously daily
  • Glargine + OADs — DRUG
    Glargine once daily subcutaneously

Study Details

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.

Key Dates

Start date
Mar 31, 2014
Status verified
Aug 2021
Primary completion
Aug 30, 2020
Completion
Aug 30, 2020

Study Design

Enrollment
273 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Liraglutide + OADs
    Liraglutide once daily in combination to oral anti-diabetic agents (OADs)
  • Active Comparator: Glargine + OADs
    Glargine once daily in combination to oral anti-diabetic agents (OADs)

Primary Outcome Measure

Glycemic Control at Hospital Discharge and 6 Months Follow up [ Time Frame: Hospital discharge, 6 months (26 weeks) ]

Locations (5)

FacilityCityStateZIPSite coordinators
University of MiamiMiamiFlorida--
Emory University HospitalAtlantaGeorgia30324-
Emory Universtiy Hospital at MIdtownAtlantaGeorgia--
Grady Memorial HospitalAtlantaGeorgia30303-
State University of NY at BuffaloNew YorkNew York--

Find similar trials in Miami, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
University of Miami· Miami, FLEmory University Hospital· Atlanta, GAEmory Universtiy Hospital at MIdtown· Atlanta, GAGrady Memorial Hospital· Atlanta, GAState University of NY at Buffalo· New York, NY

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