Adding One Shot of APIDRA® to LANTUS® + OADs Helped Patients Reach A1C Goal69
Adding APIDRA® once a day achieved significant A1C reductions from baseline to
endpoint—breakfast group: from 7.35% to 7.03%; main meal group: from 7.29% to 6.94%
(P<0.0001)
OPAL=Orals Plus APIDRA® and LANTUS®.
Main meal=meal producing the highest elevation of BG.
Results from a 24-week, multicenter, randomized, open-label, parallel-group study
of 316 patients with type 2 diabetes who were suboptimally controlled with LANTUS®
+ OADs. Patients were randomized to the breakfast group (n=162) or the main meal
group (n=154). One dose of APIDRA® was added to their existing therapy to assess
the relative efficacy of administering prandial insulin before breakfast or before
the main meal.
From Lankish69
- Treatment equivalence of the 2 mealtime glulisine regimens was demonstrated
Effect on weight
- Body weight was virtually unchanged from baseline to endpoint in both the breakfast
and the main meal groups
- Main meal group: + 0.9 kg
- Breakfast group: + 1.0 kg
a Hypoglycemia was confirmed by a BG measurement
of ≤60 mg/dL. Severe hypoglycemia was defined as an event with symptoms consistent
with hypoglycemia during which a person required assistance of another person and
associated with a BG ≤36 mg/dL and/or prompt recovery after oral carbohydrates,
intravenous glucose, or glucagon administration.
b(P=NS)
From data on file32 and Lankisch.69
- Hypoglycemic episodes reported as serious AEs: one patient
- AEs possibly related to treatment: weight gain (2 patients)
Adding APIDRA® Once Daily to LANTUS® + OADs Provided Significant PPG Reductions69
- APIDRA® given once daily at breakfast or the main meal significantly lowered
A1C. Doses started at a mean of 5 units per day and were individually titrated to
a 2-hour postprandial BG goal of ≤135 mg/dL and a fasting BG goal of ≤99 mg/dL,
while seeking to avoid hypoglycemia
- In another study, regardless of BG monitoring method used, adding one shot of APIDRA®
to the largest meal led to a significant A1C improvement32
- Electronic monitoring: baseline A1C: 7.9% to endpoint 7.2%; standard monitoring:
baseline A1C: 7.8% to endpoint 7.0% (P<0.0001)
- A1C goal of ≤7% was achieved in 55% of patients who measured their BG levels using
standard monitoring and 45% of patients who electronically transferred their BG
readings (P=NS)
- Serious AEs: in electronic transfer group, n=4 (2.8%); in standard monitoring group,
n=7 (4.7%)
- Severe symptomatic hypoglycemia: in electronic transfer group=0.04 events/patient-year;
in standard monitoring group=0.02 events/patient-year
- Hypoglycemia is the most common adverse reaction of insulin therapy, including LANTUS®
or APIDRA®, and may be life-threatening
- Severe life-threatening, generalized allergy, including anaphylaxis, can occur
- A reduction in the LANTUS® or APIDRA® dose may be required in patients with
renal or hepatic impairment
Adding rapid-acting insulin
to a LANTUS® regimen >
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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