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Progression from Basal to Pre-mixed or Rapid-acting Insulin
(p=0.004 and 0.0001, respectively). A large trial included 393 patients with In some patients whose hyperglycemia is not adequately controlled with
type 2 diabetes treated with insulin glargine and OADs and a single bolus oral agents and basal insulin, intensifying with pre-mixed insulin to provide
dose of insulin glulisine.
51
HbA
1c
levels showed significant reductions, basal and prandial insulin can be as effective as basal insulin plus
which were similar whether the bolus dose was given at breakfast time or metformin.
56
This was shown in the IMPROVE observational study in which
at the time of the largest daily meal. a subgroup of 497 patients who had previously received NPH (n=497) or
analog basal insulin (n=245) switched to pre-mixed insulin aspart 70/30
Factors that contribute to poor glycemic control include unpredictable (BIAsp 70/30).
57
The incidence of major and minor hypoglycemia decreased
food intake (including conditions such as diabetic gastroparesis) and from baseline to final visit (major: 0.171 to 0.011; minor: 9.70 to 5.89
physical activity, imprecise administration of insulin by injection, and events/patient-year). In addition, HbA
1c
and fasting blood glucose were
frequent illness. Continuous subcutaneous insulin infusion (CSII) provides significantly reduced from baseline, as was post-prandial blood glucose,
the flexibility to control pre-meal hyperglycemia using different basal with 33.8% of patients achieving the HbA
1c
target of <7% without
rates and post-prandial hyperglycemia by using more precise pre-meal hypoglycemia. In this study, bodyweight was unaffected by BIAsp 70/30
insulin boluses. Insulin pumps allow patients to vary their basal rate on an treatment. It was concluded that patients with type 2 diabetes that is
hourly basis, decreasing the rate overnight or with exercise, or increasing inadequately controlled on basal insulins may improve their glycemic
it to account for insulin resistance caused by early morning secretion of control by intensification to BIAsp 70/30 therapy. The 1-2-3 study
cortisol and growth hormone. In type 1 diabetes, this results in lower evaluated the efficacy and safety of BIAsp 70/30 administered once, twice,
HbA
1c
and lower daily insulin dose than MDIs, but may cause weight or three times daily in patients with type 2 diabetes.
58
In this 48-week
gain.
51
With MDIs the peak effect of insulin may not correspond with food observational study, 41% of patients achieved target HbA
1c
values of <7%
intake, which can lead to hypoglycemia. Insulin dosing with the pump can with once-daily dosing, 70% with twice-daily dosing, and 77% with thrice-
be calculated according to caloric and carbohydrate intake, with basal daily dosing. Therefore, a pre-mixed insulin analog is a reasonable
insulin adjusted to changes in activity. When there is an elevation in blood approach for diabetes management, particularly in those individuals who
sugar, a small supplemental bolus can be delivered without concern tend to eat two large meals a day.
regarding the peak effect of insulin or the need for an additional injection.
This factor can moderate the extreme fluctuations in blood sugar and By contrast, results from the PREFER study showed that basal–bolus
result in enhanced glycemic control, as evidenced by lower HbA
1c
levels.
52
insulin therapy (insulin detemir plus insulin aspart) and BIAsp 70/30 were
CSII by a pump is the standard of care for type 1 diabetes patients and is equally effective in lowering HbA
1c
values for insulin-naïve patients (mean
also used by many patients with type 2 diabetes. However, there is limited decrease over 26 weeks 1.69% with basal–bolus and 1.42% with pre-mixed
information available regarding the use of this approach to therapy in type insulin aspart 70/30; p=0.106).
59
However, basal–bolus therapy was
2 diabetes. Pump therapy is very effective, but not more effective than superior for patients with prior insulin use (mean decrease 1.21% with
MDI in decreasing HbA
1c
levels in patients with type 2 diabetes. Some basal–bolus and 0.75% with pre-mixed insulin aspart 70/30; p=0.0129).
small, open-label, uncontrolled studies report better quality of life in Rates of minor hypoglycemia were similar in both treatment groups. Major
patients on pump therapy compared with those using MDI.
53
Limitations hypoglycemic episodes occurred in five patients in the basal–bolus group
of pump therapy include the cost and a risk of mechanical failure, compared with none in the group receiving pre-mixed insulin.
59
resulting in hypo- or hyperglycemia. Insulin pump use also requires a high
degree of motivation on the part of the patient. Continuous glucose An open-label study compared two insulin analog therapies (prandial
monitoring (CGM) devices are now available to better detect patterns pre-mixed therapy [PPT] -50% insulin lispro protamine suspension and 50%
in blood glucose variation, and are commonly used by patients using insulin lispro versus insulin glargine and insulin lispro basal/bolus therapy
an insulin pump. [BBT]) in 187 type 2 diabetes patients who were previously treated with
insulin glargine (≥30 units/day) plus oral agents.
60
After 24 weeks of
Intensification from Basal Insulin to treatment, the proportions of patients achieving target HbA
1c
<7.0% (PPT
Pre-mixed Insulin versus BBT) were 54 versus 69% (p=0.009). PPT, however, was not shown
Pre-mixed insulin preparations provide an alternative to basal–bolus to be inferior to BBT on the pre-specified non-inferiority margin of 0.3%.
dosing that does not involve multiple insulin preparations. Compared with The incidence of hypoglycemic episodes was similar in the two groups. It
pre-mixed human insulin, pre-mixed analogs may provide a glucose- was concluded that the reduction in HbA
1c
, proportion of patients reaching
lowering profile that more closely mimics the physiological secretion of HbA
1c
targets, hypoglycemia, and number of required injections should be
insulin, thus providing better glycemic control and less hypoglycemia.
54
In considered when deciding whether to use either PPT or BBT as insulin
addition, compared with pre-mixed human insulin preparations, pre-mixed replacements in type 2 diabetes.
insulin analogs allow patients more flexibility in timing their meals, since
pre-mixed insulin analogs can be administered up to 15 minutes after Cost-effectiveness of Intensive Insulin Therapies
starting to eat a meal.
55
Pre-mixed insulins are generally appropriate for The aim of early initiation of insulin therapy is to prevent short-term
patients who desire a convenient and simple insulin regimen, are unwilling complications, reduce long-term morbidity and mortality, and potentially
to administer MDIs or use an insulin pump, are unwilling to or cannot alter the natural course of type 2 diabetes. Fewer complications, including
undertake carbohydrate counting, have a relatively predictable (routine) hospital visits, translates to a potential decrease in the cost of healthcare.
lifestyle, and consume meals with approximately the same composition Although optimal disease management is patient-specific, achieving and
of calories, carbohydrates, fats, and fiber at fairly consistent and maintaining tight glycemic control are the primary goals of therapy.
reproducible times every day. Because many type 2 diabetes patients will eventually require insulin
US ENDOCRINOLOGY 43
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