Abstract
Intensive insulin therapy (IIT) based on multiple daily injections of long plus rapid-acting
insulin has been demonstrated to reduce mortality and morbidity associated with chronic
hyperglycemia in T1DM patients. The objective of this study was to assess and compare
the postprandial glycemic profile over a diurnal 12 h-period produced by the administration
of a new NPH plus regular human DNA recombinant IIT (test regimen) relative to the
reference IIT in T1DM patients. A phase IV, single-center, open-label, randomized,
multiple-dose, balanced, cross-over study in 12 T1DM patients was conducted. Patients
were assigned to receive either the test (Densulin® N (NPH) plus Densulin® R (regular),100 UI/ml, Denver Farma, Argentina) followed by the reference (InsulatardHM® (NPH) plus ActrapidHM® ,100 UI/ml, Novo Nordisk Pharma Argentina) regimens or viceversa, according to a random
sequence. Each treatment regimen consisted of 2 phases of an ambulatory run-in period
of 7 days followed by 12 h confinement period. Blood glucose levels were measured.
Glycemic profile was evaluated through glycemic plasma-concentration time curves,
area under the time-concentration glycemic curves from basal to 2 h (GlyAUC0–2) and
to 12 h (GlyAUC0–12) postprandial, and maximum glycemic postprandial concentration
(GlyCmax). 12 hour glycemic concentration-time curves were similar for both test and
reference regimens. Geometric least square means ratios Test/ref regimens and their
90% confidence interval for GlyAUC0–2, GlyAUC0–12 and GlyCmax were 94.33 (81.13–125.09),
107.75 (94.05–123.45) and 105 (92.89–118.68), respectively. Both regimens presented
similar safety profile. This study demonstrated that the new human DNA recombinant
NPH and regular insulin is equally effective to the reference regimen for postprandial
diurnal glycemic profile.
Key words glycemic profile - NPH plus regular insulins - Type 1 Diabetes Mellitus
