How can I talk to patients about beginning insulin therapy?
What data demonstrate the efficacy of LANTUS® in combination
with oral agents?
What is the appropriate dose when starting a patient on
LANTUS®?
What are some options for titrating LANTUS®?
What insulin delivery systems are available for use with
LANTUS®?
How can the LANTUS® SoloSTAR® pen benefit my patients?
How long can LANTUS® be stored?
LANTUS® has demonstrated its efficacy in clinical trials, but how has
it been shown to work in real-world clinical practice?
How can I talk to patients about beginning insulin therapy?
Inform patients about the progressive nature of the disease, and be sure that they
understand that their pancreas is no longer making enough insulin.46 Based on data from
2003-2004, about 40% of patients with diabetes nationwide were not adequately controlled,
that is to say, an A1C level of more than 7%.65 Patients may focus on blaming themselves for their
uncontrolled blood glucose, but you can help them focus on the positive aspects
of managing their diabetes.46
Inform patients that adding insulin may help improve their glycemic control. According
to the ADA, insulin is an effective way to lower blood glucose.73 Be sure to tell your patients that insulin works
as part of an overall treatment plan, along with diet, exercise, and other diabetes
medications. In a survey, about 80% of patients with type 2 diabetes taking OADs
said they would consider taking insulin based on their doctor’s recommendation.
Helping patients get their blood glucose under control earlier in the disease process
may help reduce their risk of long-term complications.
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What data demonstrate the efficacy of LANTUS® in combination with oral agents?
Adding LANTUS® to an oral regimen has been shown to be more effective at improving
and sustaining glycemic control when compared to the intensification of OADs alone.36
In a 24-week study, 405 patients with type 2 diabetes were randomized to starting
LANTUS® plus OADs or conventional therapy with physician adjustment of oral-glucose
lowering agents. At the beginning of the study, the baseline A1C for these groups
was 8.6% for LANTUS® and 8.5% for conventional OADs. Patients taking LANTUS®
with OADs were 1.68 times more likely to achieve 2 consecutive A1C levels ≤6.5%
with a P value of 0.049. Regardless of the treatment group, the primary outcome
was more likely to be achieved in participants with a diabetes duration of less
than 5 years versus 5 years or more.36
Adapted from Gerstein.
36
In the Treat-to-Target Trial, LANTUS® plus orals effectively lowered A1C more
than 1% in patients inadequately controlled on oral agents alone.33
The trial studied 756 patients taking 1 or 2 OADs with inadequate glycemic control,
defined as having an A1C level of greater than 7.5%. These patients were started
on an insulin regimen of 10 units/day and adjusted weekly to target fasting blood
glucose, or FBG ≤100 mg/dL. At 24 weeks, the mean A1C had been lowered by 1.7%.33
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What is the appropriate dose when starting a patient on LANTUS®?
When starting a type 2 diabetes patient on LANTUS®, there are certain guidelines
for effective once-daily dosing depending on the patients treatment history:
*To reduce the risk of hypoglycemia.
Adapted from LANTUS® Prescribing Information.3
- When initiating LANTUS® in insulin-naïve patients, add 10 units or 0.2 units/kg
to OADs
- When switching patients from once-daily NPH to LANTUS®, substitute 1 unit for
1 unit
- Twice-daily NPH users who switch should initiate their LANTUS® dose at 80% of
their total daily NPH dose
- When switching a premix insulin patient to LANTUS®, begin their dose at 80%
of the intermediate-acting portion of their premixed insulin
The recommended starting dose of LANTUS® in patients with type 1 diabetes should
be approximately one-third of the total daily insulin requirements. Prandial insulin
should be used at mealtime to satisfy the remainder of the daily insulin requirements.3
The starting dose should be individualized based on the type of diabetes and whether
the patient is insulin naive. Administer LANTUS® subcutaneously once daily at
any time of day, but at the same time every day. Rotate injection sites within an
injection area (abdomen, thigh, or upper arm) to reduce the risk of lipodystrophy.
Converting from other insulin therapies may require adjustment of timing and dose
of LANTUS®. Closely monitor glucose levels, especially upon converting to LANTUS®
and during the initial weeks thereafter.
To learn more about LANTUS® dosing, please visit the dosing page, or read the full Prescribing Information.
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What are some options for titrating LANTUS®?
There are two suggested options for LANTUS® titration to help patients reach
their target fasting blood glucose, or FPG, levels. The first is to start the patient
on 10 units or 0.2 units/kg, then increase the dose by 1 unit every day until the
FPG is less than or equal to 100 mg/dL.36
The second option you may consider is to start the patient on 10 units per day of
LANTUS® and adjust the dose weekly to reflect the patient’s need. Take the mean
of the patient’s self-monitored FPG from the preceding 2 days. As you can see from
this chart, the LANTUS® dose should be increased in doses of 2, 4, 6, or 8 depending
on the FPG value. Continue to adjust the dose weekly until the target FPG is less
than or equal to 100 mg/dL.
33
b Adjust dose subsequent to patient’s need.
c Dosage was not increased that week if there were any episodes of documented
hypoglycemia (<72 mg/dL) during the preceding week.
Adapted from Riddle.33
The starting dose should be individualized based on the type of diabetes and whether
the patient is insulin naive. Administer LANTUS® subcutaneously once daily at
any time of day, but at the same time every day. Rotate injection sites within an
injection area (abdomen, thigh, or upper arm) to reduce the risk of lipodystrophy.
Converting from other insulin therapies may require adjustment of timing and dose
of LANTUS®. Closely monitor glucose levels, especially upon converting to LANTUS®
and during the initial weeks thereafter.
To learn more about LANTUS® titration, please visit the titration page or read the full Prescribing Information.
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What insulin delivery systems are available for use with LANTUS®?
LANTUS® long-acting insulin is a solution for injection, and is available in
the following delivery systems:
3
- 10 mL Vial (1000 Units/10 mL)
- 3 mL Cartridge systems for use only in OptiClik® (300 Units/3 mL)
- 3 mL LANTUS® SoloSTAR® prefilled disposable insulin pen (300 Units/3 mL)
LANTUS® SoloSTAR® is an easy-to-use pen for administering LANTUS®. It
is a prefilled, disposable insulin pen delivery system. It is easy to teach, and
easy to use. The LANTUS® SoloSTAR® can be set from 1 to 80 units in 1-unit
steps, dialed both up and down. Once opened, LANTUS® SoloSTAR® may be used
for up to 28 days without refrigeration.
Patients should be instructed on proper injection technique and to closely follow
the instructions in the instruction leaflet that accompanies the LANTUS® SoloSTAR®
pen. If instructions are not followed, the patient may get too much or too little
insulin, which can affect blood glucose levels.
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How can the LANTUS® SoloSTAR® pen help my patients?74
Prefilled, disposable pens like the LANTUS® SoloSTAR® are easy-to-use devices
for administering insulin. LANTUS® SoloSTAR® is the only insulin pen in
which the dose can be set from 1-80 units in 1-unit steps, dialed both up and down.
Once opened, LANTUS® SoloSTAR® can be used for up to 28 days without refrigeration.74
A vial of LANTUS® contains 10 mL, while the same prescription for the LANTUS®
SoloSTAR® pen has 5 pens with 3 mL each. A patient can get 50% more LANTUS® units
for the same copay as the vial on most insurance plans.
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How long can LANTUS® be stored?
Each LANTUS® SoloSTAR® pen contains 300 units of insulin and may be used
up to 28 days after the first injection.
Before being used, the LANTUS® SoloSTAR® pen should be stored in the refrigerator.
Do not store it in the freezer, nor should it be used if it has accidentally been
frozen. Once opened, pen should not be refrigerated, but kept at room temperature,
up to 86°F. Instruct your patients to keep the LANTUS® SoloSTAR® pen away
from direct sunlight.
Vials must also be discarded 28 days after being opened. Unlike the LANTUS®
SoloSTAR® pen, vials should be refrigerated when not in use. If refrigeration
is not possible, the open vial can be kept unrefrigerated for up to 28 days away
from direct heat and light, as long as the temperature is not greater than 86°F.3
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LANTUS® has demonstrated its efficacy in clinical trials, but how has has it
been shown to work in real-world clinical practice?
In a real-world observational study of 12,216 patients, LANTUS® plus OADs provided
sustained glycemic control, with a neutral effect on weight for patients uncontrolled
on oral therapy alone.
1,2
Mean baseline characteristics of 12,216 patients
A1C: 8.7% (±1.4%)
BMI: 29.0 (±4.7) kg/m2
Age: 63.9 (±11.3) years
LANTUS® + OADs Improved and Sustained Glycemic Control for up to 32 Months1,2
In 2 extension studies—one at 20 months and one at 32 months—of a 9-month, uncontrolled,
observational study of the use of LANTUS® in everyday practice in Germany, 12,216
patients with type 2 diabetes not adequately controlled by OADs received add-on
LANTUS® treatment. Dosing decisions, including any changes to the OADs, were
made at the physicians’ discretion.
Adapted from Schreiber.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
b n=number of patients with data available
at baseline and 32 months.
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
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 study
- 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
Over the 32-month study, patients taking 1 or 2 OADs with inadequate glycemic control
(defined as an A1C of greater than 7.5%) and a mean A1C at baseline of 8.7%, were
given LANTUS® as part of their treatment regimen. All dosing decisions, including
any changes to the OADs, were made at physicians’ discretion. After 32 months, in
those patients who continued in the extension of the study the incidence of hypoglycemia
was 0.1%, the effect on weight was neutral, and the mean A1C was lowered by 1.6%.1 2
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