Glargine Vs. NPH In Combo With
Oral Treatment In Type 2’s
Glargine showed fewer episodes of nocturnal
hypoglycemia.
A European, randomized, 29-center, open-label
study compared the safety and efficacy of two
formulations of insulin glargine and neutral protamine
Hagedorn (NPH) human insulin, in combination with
oral agents, in patients with Type 2 diabetes
mellitus (DM).
Two-hundred-and-four patients with Type 2 DM,
in whom oral treatment alone was inadequate, were
randomized to insulin glargine with 30 micro g/ml
zinc [insulin glargine (30)], or insulin glargine
with 80 micro g/ml zinc [insulin glargine (80)]
or NPH insulin subcutaneously once daily. Insulin
was titrated to aim for fasting blood glucose
(FBG) values between 4 and 7 mmol/l.
All participants received oral therapy during
the 3-week titration phase and 1-week maintenance
phase of the trial. RESULTS: No differences between
treatment groups were observed in adjusted mean
fasting plasma glucose; significant decreases
of 3.4 mmol/l, 3.5 mmol/l and 3.1 mmol/l were
observed within the insulin glargine (30), insulin
glargine (80) and NPH insulin groups, respectively
(P < 0.0001 in each case).
No differences between groups, but significant
changes within groups, were observed in self-monitored
FBG, mean FBG, blood glucose profile, stability
of FBG, nocturnal blood glucose, fasting serum
C-peptide, non-esterified fatty acids, hemoglobin
A1c, fructosamine and fasting serum insulin.
A significantly greater proportion of NPH insulin
patients experienced symptomatic nocturnal hypoglycemia
(19.1 NPH group vs. 7.3% glargine groups; P =
0.0123). Both insulins were well tolerated; one
patient in each group experienced an injection
site reaction.
From the results it was concluded that insulin
glargine is as safe and effective as NPH insulin
given once daily and in this study caused fewer
episodes of nocturnal hypoglycemia. Diabet. Med.
20, 545-551 (2003)
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