Intravenous Exenatide (Byetta) for the Treatment of Perioperative Hyperglycemia: Rollover Phase I/II Trial

Registration

Registration

NCT00882050

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE1; PHASE2

Masking

DOUBLE

Status

COMPLETED

Enrollment

104

Start

2009-03

Primary completion

2016-04

Lead sponsor

Thomas Jefferson University

Conditions

Euglycemia; Hypoglycemia; Hyperglycemia

Interventions

DRUG:Exenatide 0.27 ng/kg/min; DRUG:Exenatide 0.41 ng/kg/min; DRUG:Placebo

Results posted

TRUE

Registered primary outcomes

• The Primary Objective is to Determine the Ability of Intravenous Exenatide to: Maintain Intraoperative Euglycemia in Subjects With Initial Blood Glucose < 126 mg/dL in Surgical Subjects as Compared to Placebo, [Baseline and 90 minutes after starting infusion;]