LANTUS® + orals effectively lowered A1C more than 1% in patients inadequately controlled on oral agents alone
5
Supervised titration resulted in substantial fasting plasma glucose (FPG) reductions
6
*Week 0 based on a starting LANTUS® dose of 10 units. Average LANTUS® dose
at 4 weeks was 25 units.
Preliminary data from a 24-week, multicenter, randomized, parallel, open-label trial
of 756 overweight men and women that compared the abilities and associated hypoglycemic
effects of LANTUS® long-acting (basal) insulin added to prestudy oral diabetes
medications (OADs) (n=367) vs NPH insulin (n=389) added to prestudy OADs in insulin-naïve
patients with inadequate glycemic control (A1C >7.5%) on 1 or 2 oral agents (sulfonylureas,
metformin, or thiazolidinediones) and treated to a target A1C ≤7.0%.
From data on file.6
A 24-week, multicenter, randomized, parallel, open-label trial compared the
effects of LANTUS® (n=367) and NPH insulin (n=389) in insulin-naïve patients
with inadequate glycemic control on 1 or 2 oral agents (sulfonylureas, metformin,
or thiazolidinediones).
From Riddle et al.5
- The majority of patients achieved A1C goals
- 1.7% mean A1C reduction at 24 weeks
IMPORTANT SAFETY INFORMATION FOR LANTUS®
LANTUS® is indicated for once-daily subcutaneous administration, at the same
time each day, for the treatment of adult and pediatric patients (6 years and older)
with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who
require basal (long-acting) insulin for the control of hyperglycemia.
LANTUS® SoloSTAR® is a disposable prefilled insulin pen. Needles and the Lantus® SoloSTAR® pen must not be shared.
LANTUS® MUST NOT BE DILUTED OR MIXED WITH ANY OTHER INSULIN OR 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.
LANTUS® is contraindicated in patients hypersensitive to insulin glargine or
the excipients.
Hypoglycemia is the most common adverse effect of insulin, 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 type and/or regimen should be made cautiously and only under
medical supervision. Concomitant oral antidiabetes treatment may need to be adjusted.
Other adverse events commonly associated with LANTUS® include the following:
lipodystrophy, skin reactions (such as injection-site reaction, pruritus, rash),
and allergic reactions.
In clinical studies in adult patients there was a higher incidence of treatment-emergent
injection-site pain (2.7% LANTUS® vs 0.7% NPH). The reports of pain at the injection
site were usually mild and did not result in discontinuation of therapy.
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