An observation study in everyday practice demonstrated.
LANTUS® and APIDRA®: effective in a basal-prandial regimen32
Significant BG and A1C reductions
Observational 6-month study (median: 159 days) of efficacy and safety of APIDRA®
and LANTUS® in 5695 patients with type 2 diabetes uncontrolled on LANTUS® +
orals or other insulin regimens aside from APIDRA® and LANTUS®. At study
start and follow-up, 94.8% and 95.7% of patients, respectively, injected APIDRA®
in 3 daily mealtime boluses. From data on file.32
Similar reductions were seen in noon and evening BG readings
b Total daily doses of APIDRA® and LANTUS®
(APIDRA® study start: 34.4 ± 23.0 Units; follow-up: 39.3 ± 24.1 Units) (LANTUS®
study start: 24.4 ± 13.0 Units; follow-up: 26.2 ± 14.1 Units). Mean weight change:
(study start: 90.1 ± 17.5 kg; follow-up: 88.7 ± 17.1 kg). There were fewer patients
with data available at 6 months vs the start of the trial. From data on file.32
- Prior to study, 62.7% of patients used LANTUS® as part of their overall diabetes
treatment regimen
- Changes in total daily insulin dose and weight were minimalb
Rates of AEsc from data on file.32
- Because of the observational nature of this study, the frequency of AEs must be
interpreted with caution as they may have been underreported
- Serious hypoglycemia: 2 events
- Hypoglycemiad: 41 events (27.5%)
- Most common AEs possibly related to treatment: "hypoglycemia" and "skin and subcutaneous
tissue disorders"e
c Data are based on numbers of patients
from the intent-to-treat population (all patients who received study medication)
except as indicated.
d Number of events (percentage of events).
e Includes hyperhidrosis, cold sweats, dermatosis,
erythema, and allergic pruritus.
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Please scroll down for additional Important Safety Information for APIDRA®.
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®
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