Evaluation of a novel continuous glucose measurement device in patients with diabetes mellitus across the glycemic range.

Background: This glucose clamp study assessed the performance of an electrochemical continuous glucose monitoring (CGM) system for monitoring levels of interstitial glucose. This novel system does not require use of a trocar or needle for sensor insertion.

Method: Continuous glucose monitoring sensors were inserted subcutaneously into the abdominal tissue of 14 adults with type 1 or type 2 diabetes.

Reduction in intrasubject variability in the pharmacokinetic response to insulin after subcutaneous co-administration with recombinant human hyaluronidase in healthy volunteers.

Background: This study was designed to test the hypothesis that co-administration of recombinant human hyaluronidase (rHuPH20) with regular insulin or insulin lispro will reduce intrasubject variability in pharmacokinetic end points compared with lispro alone.

Methods: Healthy adult volunteers (18-55 years old) were enrolled in this phase 1, randomized, double-blind, crossover study. Subjects were administered two injections, each on a separate occasion, of three treatments during six euglycemic clamps.

Accelerated insulin pharmacokinetics and improved postprandial glycemic control in patients with type 1 diabetes after coadministration of prandial insulins with hyaluronidase.

Objective: To compare the pharmacokinetics, pharmacodynamics, and safety of insulin lispro or regular human insulin (RHI) with or without recombinant human hyaluronidase (rHuPH20) administered before a standardized meal.

Research Design And Methods: In this four-way, crossover study, 22 patients with type 1 diabetes received injections of individually optimized doses of lispro or RHI with and without rHuPH20 before a liquid meal.

Results: With rHuPH20 coadministration, early insulin exposure (0-60 min) increased by 54% (P = 0.

Co-administration of liraglutide with insulin detemir demonstrates additive pharmacodynamic effects with no pharmacokinetic interaction.

Aim: To compare the pharmacokinetic (PK) [area under the curve (AUC₀(-)₂₄ (h), C(max))] and pharmacodynamic (PD) (AUC(GIR) ₀(-)₂₄ (h), GIR(max)) properties of single-dose insulin detemir in the presence or absence of steady-state liraglutide (1.8 mg dose) in subjects with type 2 diabetes to determine whether co-administration affected the PK and PD profiles of either therapeutic agent.

Methods: Following a 3-week washout of oral antidiabetic agents (OADs) other than metformin, PK and PD assessments during three euglycaemia clamps were conducted: day 1 following a single dose of insulin detemir alone (0.

Analysis of the Nova Stat Strip® glucose meter for real-time blood glucose determinations during glucose clamp studies: "don't swap horses in midstream".

Proper performance of glucose clamps is critically dependent on reliable blood glucose (BG) measurements. A number of requirements have to be fulfilled by a system that aims to replace the laboratory devices that are currently in use. Many more aspects need to be taken into account besides the accuracy of BG measurement.

Pharmacokinetics and pharmacodynamics of insulin lispro protamine suspension compared with insulin glargine and insulin detemir in type 2 diabetes.

Objective: The primary aim was to evaluate duration of action of a single 0.8 U/kg dose of insulin lispro protamine suspension (ILPS) in type 2 diabetes (T2DM) patients; secondarily to compare onset and duration of action of ILPS, glargine (G), and detemir (D) (0.8 U/kg) and evaluate pharmacokinetic (PK) and pharmacodynamic (PD) dose responses of ILPS.

Glycemic exposure is affected favorably by inhaled human insulin (Exubera) as compared with subcutaneous insulin glargine (Lantus) in patients with type 2 diabetes.

Background: The objective was to compare the effects on glycemia of adding either inhaled human insulin (Exubera [EXU] [insulin human (recombinant DNA origin) inhalational powder]) or subcutaneous insulin glargine (GLA) to the treatment regimens of patients with type 2 diabetes uncontrolled with oral antidiabetic drugs.

Methods: Forty patients were randomized to receive either EXU three times daily prior to meals or subcutaneous GLA once daily in a crossover design. Interstitial glucose concentrations were monitored using a continuous glucose monitoring system (CGMS) for the final 72-h period of 8 treatment days.

An analysis of how to measure glucose during glucose clamps: are glucose meters ready for research?

This article provides a perspective on the challenges of appropriate glucose measurement in the context of glucose clamp experiments. In a first step, the core outcome parameters of a clamp experiment, the blood glucose target level, and the glucose infusion rate will be identified. The relation of these core parameters to glucose measurement are discussed.

Intra-individual variability of the metabolic effect of a novel rapid-acting insulin (VIAject) in comparison to regular human insulin.

Background: The variability of the metabolic action of insulin after subcutaneous (sc) injection hampers optimal insulin therapy. Insulin formulations with a reduced tendency to form hexamers might exhibit a reduced variability of absorption from the sc insulin depot into the blood stream.

Methods: We investigated the within-subject variability of pharmacodynamic and pharmacokinetic properties of an ultra-fast insulin (UFI) formulation and regular human insulin (RHI) in patients with type 1 diabetes.

Time-action profile of insulin detemir and NPH insulin in patients with type 2 diabetes from different ethnic groups.

Aim: To evaluate the time-action profiles and the dose-response relationship of the long-acting insulin analogues insulin detemir (IDet) and NPH insulin (NPH) in type 2 diabetic patients belonging to different ethnic groups.

Methods: Forty-eight type 2 diabetic patients belonging to different ethnic groups (three groups of 16 African Americans (AA), 16 Hispanics/Latinos (HL) and 16 Caucasians) participated in this double-blind crossover trial. Each patient took part in six 16-h isoglycaemic glucose clamps (clamp target 7.