In a pivotal trial comparing the safety and efficacy of the long-acting analog insulin Lantus(R) (insulin glargine [rDNA origin] injection) with NPH (neutral protamine Hagedorn) in patients with type 2 diabetes, previously treated with insulin alone, Lantus demonstrated a 25 percent lower risk of nocturnal hypoglycemia.
The study, published in the April issue of Diabetes Care, stated that the
lower risk of nocturnal hypoglycemia may reflect the smooth, continuous
release profile of Lantus compared with the peak of NPH, which can result in
maximum concentrations of insulin at night when NPH is given at bedtime.
Severe hypoglycemia was observed in only one (0.4 percent) Lantus patient
versus six (2.3 percent) NPH insulin patients (P=0.0581). Prior to enrollment
in the study, patients had been treated with long-acting insulin with or
without short-acting insulin.
Lantus is indicated for once-daily subcutaneous administration at bedtime
in the treatment of adult patients with type 2 diabetes or adult and pediatric
patients (ages 6 and above) with type 1 diabetes who require basal
(long-acting) insulin for the control of hyperglycemia.
This 59-center, randomized, open-label comparison of Lantus and NPH,
enrolled 518 patients with type 2 diabetes, ages 40-80, who had been receiving
NPH insulin treatment (with or without regular insulin for postprandial
control) for more than three months. Because Lantus is a clear solution and
can easily be distinguished from NPH insulin visually, an open-label design
was required. In this study, patients were randomized to receive either
Lantus (n=259) once-daily or NPH insulin (n=259) once or twice daily for
28-weeks. Doses were adjusted to obtain target fasting glucose of <6.7
mmol/l. At the end of the study, the median total daily insulin dose in both
treatment groups was 0.75 IU/kg.
Lantus was associated with 25 percent reduction in nocturnal hypoglycemia
during the treatment period following the dose-titration phase (26.5 percent
vs. 35.5 percent, P=0.0136). Patients in the Lantus group also experienced
less weight gain than those in the NPH group (0.4 kg vs 1.4 kg, P=0.0007).
The treatment groups showed similar improvements in HbA1c, after patients
began with an average baseline HbA1c of approximately 8.5 percent. The
treatments also were associated with similar reductions in fasting glucose
levels and overall mild symptomatic hypoglycemia was similar in Lantus
patients (61.4 percent) and NPH patients (66.8 percent).
Lantus(R) (insulin glargine [rDNA origin] injection) Information
The adverse events commonly associated with Lantus include the following:
hypoglycemia, lipodystrophy, skin reactions (such as injection-site reaction,
pruritus, rash) and allergic reactions. Sodium retention and edema may also
occur with the use of any insulin therapy.
In clinical studies in adult patients there was a higher incidence of
treatment-emergent injection-site pain (2.7 percent Lantus versus 0.7 percent
NPH). The reports of pain at injection site were usually mild and did not
result in discontinuation of therapy.
Hypoglycemia is the most common adverse effect of insulins, including
Lantus. As with all insulins, the timing of hypoglycemia may differ among
various insulin formulations. Glucose monitoring is recommended for all
patients with diabetes. Any change of insulin should be made cautiously and
only under medical supervision.
Lantus must not be diluted or mixed with any other solution. If mixed or
diluted, the solution may become cloudy, and the onset of action/time to peak
effect may be altered in an unpredictable manner.
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