Profiles that Mimic Physiologic Insulin Secretion3,61
Steady, 24-hour basal coverage with LANTUS®3,62
- LANTUS® significantly lowered fasting blood glucose using a basal-prandial regimen3
- No pronounced peak—patients do not need to eat at a specific time to balance a peak
- Lantus and a rapid-acting insulin helped many patients achieve A1C goal63
- Flexible premeal or postmeal dosing may accommodate changing appetites and schedules61
LANTUS® and APIDRA®: An Effective Basal-Prandial Regimen
LANTUS® and APIDRA® demonstrated significant A1C and postprandial BG reductions70
a At week 24, both groups reached the ADA
and AACE goals for PPG at all time points measured.
b Baseline postprandial BG levels for simplified
and carb-counting groups were: 212.0 and 190.9 mg/dL (postbreakfast), 203.0 and
184.7 mg/dL (postlunch), and 220.5 and 203.3 mg/dL (postdinner), respectively.
In a 24-week, controlled, open-label, randomized, parallel-group study of patients
with type 2 diabetes not controlled on insulin therapy (≥2 injections per day),
with or without metformin, for at least 3 months, patients were started on 1 injection
of LANTUS® per day and APIDRA® 3 times daily, using 2 different dosing algorithms
to determine APIDRA® dose.
From Bergenstal.70
- A majority of patients in both groups achieved A1C <7%: 73% with the simplified
algorithm vs 69% with the carb-counting algorithm
- Mean FPG was significantly reduced from baseline: 40-mg/dL reduction with the simplified
algorithm vs 51-mg/dL reduction with the carb-counting algorithm
- Mean postprandial BG levels were reduced from baseline (postbreakfast, postlunch,
and postdinner)
- Simplified algorithm: 79.1-, 75.0-, and 85.2-mg/dL reductions, respectively
- Carb-counting algorithm: 62.7-, 56.0-, and 68.5-mg/dL reductions, respectively
Effect on weight
- Weight gain was not significantly different between the simplified (3.6 kg) and
carb-counting (2.4 kg) groups
c Severe hypoglycemia was defined as requiring
assistance and involved either self-monitored blood glucose (SMBG) <36 mg/dL or
treatment with oral carbohydrates, intravenous glucose, or glucagon, with a prompt
response to that therapy.
Data are based on numbers of patients from the safety population experiencing specified
AEs.
From data on file32 and Bergenstal70
- Hypoglycemic episodes reported as serious AEs: 2 events (simplified arm) and 7 events
(carbohydrate-counting arm)
- AE possibly related to treatment, reported in more than one patient: hypoglycemia
APIDRA® vs RHI in patients with type 2 diabetes71
- A1C reductions from baseline were similar between both treatment groups: 0.46% reduction
for APIDRA® vs 0.30% reduction for regular human insulin (RHI) (P=0.0029)
- Postprandial BG values were similar between treatment groups at baseline
- Postprandial BG values were significantly lowered 2 hours postbreakfast and 2 hours
postdinner
- BG values of APIDRA® and RHI
- Postbreakfast: 156 vs 162 mg/dL, respectively (P<0.05)
- Postdinner: 154 vs 163 mg/dL, respectively (P<0.05)
- The clinical relevance of the differences in postprandial BG and A1C reductions
between RHI and APIDRA® is unknown
- Efficacy was maintained regardless of whether oral agents were used
- Improved glycemic control in everyday practice in patients with type 1 diabetes
and patients with type 2 diabetes poorly controlled on prior insulin and/or oral
regimens63
See Real-World Type 2 Study results >
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.
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.
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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