Comparison of the pharmacokinetic and pharmacodynamic profiles of biphasic insulin aspart 50 and 30 in patients with type 2 diabetes mellitus: a single-center, randomized, double-blind, two-period, crossover trial in Japan

What Was Tested

The paper reports a study of Insulin Aspart, published as a randomized controlled trial.

To overcome the complicated mixing procedures required in the use of insulin formulations, premixed formulations consisting of rapid-acting and intermediate-type insulin in various mixing proportions have been developed.

Biphasic insulin aspart 50 (BIAsp50) and 30 (BlAsp30) are 2 premixed formulations containing the active ingredient insulin aspart (IAsp) and consisting of a rapid-acting component soluble IAsp) and intermediate-acting component (protamine-crystallized protracted IAsp) in ratios of 50/50 and 30/70, respectively.

Who Took Part

By PubMed's age tags, the people studied were middle-aged adults, both men and women.

Male and female patients aged > or = 20 years with a > or = 1 year history of type 2 diabetes were eligible.

Patients were randomly assigned to 1 of 2 treatment sequences: group A received BIAsp30 in period 1 and BIAsp50 in period 2; group B received BIAsp50 in period 1 and BIAsp30 in period 2.

How the Study Was Run

The researchers set it up as a randomized, double-blind and crossover study.

Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Blinding on both sides kept the participants and researchers unaware of who received Insulin Aspart.

In the crossover set-up each of the participants took both Insulin Aspart and the comparison in turn, acting as their own control.

This single-center, randomized, doubleblind, 2-period, crossover trial was conducted at the H.E.C.

The study periods were separated by a washout period of 4 to 21 days.

For PK analysis of IAsp (maximum serum IAsp concentration [C(max,IAsp); primary end point], AUC of serum IAsp 0 to 120, 240, and 480 minutes after administration [AUC(0-120 min,IAspl), AUC(0-240 min,IAsp), and AUC(0-480 min,IAsp5) respectively], and time to (Cmax,IAsp) [T(max,IAsp)] ), blood samples were drawn immediately before (baseline) and at prespecified time points over 480 minutes after administration.

The PD profiles of BIAsp50 and BIAsp30 were also examined by comparing the time course of the glucose infusion rate (GIR) using the euglycemic clamp technique.

The PD end points were AUC of GIR 0 to 120 minutes after administration (AUC(0-120 min,GIR)), maximum GIR (GIR(max)), and time to GIRmax (T(max,GIR)).

What Was Measured

Tolerability was assessed using physical examination, including vital sign measurement, electrocardiography, body weight, adverse events (AEs), and clinical laboratory analysis (hematology and serum biochemistry).

Topics PubMed links to this paper include Area Under Curve, Biphasic Insulins, Diabetes Mellitus, Type 2, Glucose Clamp Technique, Hypoglycemic Agents, Insulin and Insulin Aspart.

What This Means in Plain Language

The paper is a randomized, double-blind and crossover study of Insulin Aspart.

Results are reported in around 6 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2007 (Clinical therapeutics), a journal based in United States.

More context: the Insulin Aspart compound page.