Publications by authors named "Debra Schleusener"

Background: The V-Go is a once-daily disposable device that allows coverage of basal and prandial insulin requirements over a period of 24 hours. The aim of this proof-of-concept study was to evaluate the clinical functionality, safety, and pharmacodynamics of the V-Go delivering insulin aspart and redistributing a single basal dose of insulin glargine as a constant basal infusion supplemented with prandial insulin in subjects with type 2 diabetes mellitus.

Methods: In six subjects receiving once-daily subcutaneous (SC) injections of insulin glargine (> or =15 U/day) with or without concomitant oral antidiabetic drugs, glargine was discontinued following a 3-day baseline phase.

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Objective: To evaluate the safety and efficacy of the transition from a continuous subcutaneous insulin infusion (CSII) regimen with insulin lispro to 1 of 2 dose regimens of multiple daily injections (MDI) with insulin lispro and insulin glargine in patients with type 1 diabetes.

Methods: The study group consisted of 38 patients with type 1 diabetes who had been using CSII with insulin lispro for > or =6 months. These patients were randomized to receive insulin glargine at a dose equal to (group 1:1) or 1.

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Objective: This study was designed to assess the efficacy and safety of glimepiride plus rosiglitazone for type 2 diabetes mellitus (DM) inadequately controlled with rosiglitazone monotherapy.

Methods: This was a randomized, double-blind, placebo-controlled, multicenter study Patients were assigned to a 6-week forced titration of either glimepiride or placebo in combination with rosiglitazone (4 or 8 mg/d) followed by a maintenance period of 20 weeks. The outcomes were changes in glycosylated hemoglobin (HbA(1c)), fasting plasma glucose (FPG), lipid levels, and body weight, as well as safety measures.

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Aims: To assess smoking cessation rates achieved with nicotine gum and patch in simulated over-the-counter (OTC) and actual prescription (Rx) settings.

Design: Separate open-label studies with gum and patch in OTC and Rx settings.

Participants: There were multiple samples: OTC gum: 2981 smokers; OTC patch: 2367; Rx gum: 324; Rx patch: 669.

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