Type 1 Diabetes Clinical Trial
Official title:
Comparison of Lantus and NPH Insulin in the Dawn Phenomenon
1. To investigate the effect of insulin glargine (Lantus™) vs NPH insulin regarding
glycemic control during the early AM (dawn phenomenon) in individuals with type 1
diabetes.
2. To measure hormones implicated in the pathogenesis of the dawn phenomenon in
individuals with type 1 diabetes.
Title: COMPARISON of LANTUS and NPH INSULIN IN THE DAWN PHENOMENON
I. Background and Significance
Diabetes mellitus affects greater than 6% of the population, with type 2 more prevalent than
type 1. For individuals with type 1 diabetes, the challenge has been to replicate insulin
secretion of the healthy pancreas to maintain blood glucose as close to the non-diabetic
range as possible. Insulin regimes using insulins with varied activity profiles (multiple
daily injections or MDI) and continuous subcutaneous insulin infusion (CSII) have been
somewhat successful in "mimicking" normal pancreatic function (1, 2). For individuals with
type 1 diabetes, the benefits of near-normal, long-term glycemic control in delaying the
development and slowing the progression of long-term complications was demonstrated in the
Diabetes Control and Complications Trial (3). Intensive insulin therapy to achieve
near-normal glycemic control has been limited by a three-fold increase in episodes of
hypoglycemia (3, 4). Insulin analogs that provide more stable physiologic insulin levels
have led to the development of newer MDI regimes (5). Glargine (Lantus) is a long-acting
recombinant human insulin analog demonstrated to provide a continuous, smooth supply of
insulin with no pronounced peak over a 24-hour period (6).
An increase in blood glucose in type 1 and type 2 diabetics, and an increase in insulin
secretion to maintain normoglycemia in non-diabetics, was documented in several studies in
the 1980s (15-17). This physiological requirement for more insulin delivery (or secretion)
in the early (4:00-6:00 AM) hours was termed the "dawn phenomenon". The mechanism for the
dawn phenomenon was thought to be the overnight increase in growth hormone section, rather
than diurnal glucocorticoids (16, 18, 19). Most intensive treatment regimens of the
1980-90's, with MDI or CSII, were designed to provide more insulin in the 4:00-7:00 AM
period to cope with the dawn phenomenon which cannot be be achieved with glargine (20-21).
Continuous monitoring of blood glucose has revealed that individuals treated with CSII had
significantly better glycemic control than glargine treated individuals (22). Whether the
dawn phenomenon, with increased area under the curve blood glucose levels during the dawn
period is limiting the effectiveness of regimens with glargine is of crucial importance.
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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