INSPIRE Diabetes Study: Basal Bolus Insulin as Primary Treatment of Type 2 Diabetes
Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
Participant gender:
Summary
T2DM has become an American Epidemic. Currently 8% of the US population has diabetes and
rates may be as high as 33% by the year 2050 (1). Although there are many treatment options
for people with T2DM, none have been proven in humans to prevent the defects in insulin
secretion (2) and insulin action (3) and beta cell dysfunction (4) that result with very high
glucose levels and typically worsen as the disease progresses. Any treatment that could delay
the progression of pancreatic beta cell failure (as measured by the need for rescue therapy
with oral agents) would be a significant advancement in diabetes treatment.
Insulin therapy is appropriate at any point in T2DM disease progression, but it is commonly
only used as a rescue therapy after failure of oral therapies. A number of outpatient insulin
titration protocols have been shown to be safe and effective and speed patient's ability to
gain glucose control (5-8). Recent studies have shown that initiation of insulin at onset of
T2DM is beneficial at achieving early and long-term glucose control (6-9). However these
protocols have used intravenous human insulin in the in-patient setting, continuous
subcutaneous insulin by insulin pump or older human insulins in the out-patient setting. Many
of these protocols are unlikely to be utilized in routine patient care. To date, no "insulin
first" studies have been published with analog insulins in an outpatient basal-bolus regimen
with patient driven titration.