Real Results in Patients Who Added LANTUS® to their Existing Oral Regimens
The Schreiber Study is a large real-world study of diabetes patients who added LANTUS®,
a long-acting (basal) insulin, to their existing oral regimens. The results are
presented below. In a large-scale observational study1,2:
Mean baseline characteristics of 12,216 patients
- A1C: 8.7% (±1.4%)
- BMI: 29.0 (±4.7%) kg/m2
11
- Age: 63.9 (±11.3) years
TZD=Thiazolidinedione
aPercentages total >100% because of combination
therapy.
LANTUS® + OADs Improved Sustained Glycemic Control for up to 32 Months
1,
2
Sustained glycemic control: fasting blood glucose (FBG) reductions at 32 months1
- Average 71.8-mg/dL drop in FBG through 32 months (n=1710)b
- Mean reduction in A1C through 32 months was 1.6% from a mean baseline of 8.6% (n=1602)b
Neutral effect on weight and BMI at 32 months1
- Mean patient weight (n=1369)b:
baseline=83.0 (±14.8) kg; 32 months=82.2 (±14.6) kg
- Mean patient BMI (n=1351)b:
baseline=28.9 (±4.6) kg/m2; 32 months=28.6
(±4.7) kg/m2
b=number of patients with data available at baseline and 32 months.
Safety at 9 and 32 months1,2
- Because of the observational nature of this study with no stringent emphasis on
reporting or documenting these events, these results must be interpreted with caution
as it is possible that adverse events (AEs) may have been underreported
- Hypoglycemia occurred in 0.1% of patients at 9 months
- During the 32-month observation period, there was a total of 2 hypoglycemic events;
1915 patients were enrolled in the 32-month follow-up
- Patients with any AEs: 9 months=142 (1.2%); 32-month observation period=54
- Patients with adverse drug reactions: 9 months=26 (0.2%); 32-month observation period=4
Administration options >
CONTRAINDICATIONS
Lantus® is contraindicated in patients hypersensitive to insulin glargine or
one of its excipients.
WARNINGS AND PRECAUTIONS
Monitor blood glucose in all patients treated with insulin. Insulin regimens should
be modified cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type, or method of administration may result in the need for a change
in insulin dose or an adjustment in concomitant oral antidiabetic treatment.
Do not dilute or mix Lantus® 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. Do not administer Lantus® via an
insulin pump or intravenously because severe hypoglycemia can occur. Insulin devices
and needles must not be shared between patients.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Lantus®,
and may be life-threatening.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur.
A reduction in the Lantus® dose may be required in patients with renal or hepatic
impairment.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and
close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients
taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and
reserpine).
ADVERSE REACTIONS
Other adverse reactions commonly associated with Lantus® are injection site
reaction, lipodystrophy, pruritus, and rash.
Lantus® SoloSTAR® is a disposable prefilled insulin pen. To help ensure
an accurate dose each time, patients should follow all steps in the Instruction
Leaflet accompanying the pen; otherwise they may not get the correct amount of insulin,
which may affect their blood glucose.
Lantus® is a long-acting insulin analog indicated to improve glycemic control
in adults and children (6 years and older) with type 1 diabetes mellitus and in
adults with type 2 diabetes mellitus. Lantus® should be administered once a
day at the same time every day.
Important Limitations of Use: Lantus® is not recommended for the treatment of
diabetic ketoacidosis. Use intravenous short-acting insulin instead.
Lantus® SoloSTAR® is a disposable prefilled insulin pen.
Please click here for full prescribing information.
CONTRAINDICATIONS
Apidra® is contraindicated during episodes of hypoglycemia and in patients hypersensitive
to Apidra® or any of its excipients.
WARNINGS AND PRECAUTIONS
Closely monitor blood glucose in all patients treated with insulin. Change insulin
regimens cautiously and only under medical supervision. Changes in insulin strength,
manufacturer, type, or method of administration may result in the need for a change
in insulin dose or an adjustment in concomitant oral antidiabetic treatment. As
with all insulin preparations, the time course of Apidra® action may vary by
individual or at different times in the same individual and is dependent on many
conditions, including the site of injection, local blood supply, or local temperature.
Hypoglycemia is the most common adverse reaction of insulin therapy, including Apidra®,
which may be serious.
Severe life-threatening, generalized allergy, including anaphylaxis, can occur.
All insulins, including Apidra®, can cause hypokalemia, which if untreated,
may be serious.
A reduction in the Apidra® dose may be required in patients with renal or hepatic
impairment.
Apidra® for subcutaneous injection should not be mixed with insulins other than
NPH. Do not mix Apidra® with any insulin when used in the pump or for intravenous
administration. Insulin devices and needles must not be shared between patients.
DRUG INTERACTIONS
Certain drugs may affect glucose metabolism, requiring insulin dose adjustment and
close monitoring of blood glucose. The signs of hypoglycemia may be reduced in patients
taking anti-adrenergic drugs (e.g., beta-blockers, clonidine, guanethidine, and
reserpine).
ADVERSE REACTIONS
Other adverse reactions commonly associated with Apidra® include injection site
reactions, lipodystrophy, pruritus, and rash.
Apidra® is a rapid-acting insulin analog indicated to improve glycemic control
in adults with type 2 diabetes or adults and children (4 years and older) with type
1 diabetes.
When used as a mealtime insulin, the dose of Apidra® should be given within 15 minutes
before or within 20 minutes after starting a meal. Apidra® given by subcutaneous injection
should normally be used in regimens that include a longer-acting insulin.
Please click here for full prescribing information for Apidra®
Click herefor information on Sharps Medical Waste
Disposal.