Type 1 Diabetes Clinical Trial
Official title:
An Open-Label, Randomized, Two-Period, Crossover Study to Characterize the Insulin Exposure and Glucose Response to Meals in Type 1 Diabetic Subjects Administered Two Different Insulin Regimens Compared to the Endogenous Insulin Exposure and Glucose Response to Meals In Healthy Adult Controls
Intensive control of Type 1 Diabetes is critical in prevention of long term complications.
Unfortunately, there is a three-fold increase in hypoglycemia with intensive control.
Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment
of diabetes is composed of some form of short acting insulin regimen in order to provide
control of blood glucose excursions that are the result of glucose intake as well as a basal
insulin regimen either in a continuous administration (as in continuous subcutaneous insulin
infusion-"pump therapy"), once a day injection (insulin Glargine), twice a day (ultralente
or NPH or lente insulin) or a premixed version that is combined with the short acting
insulin (70/30 or 75/25). Often low blood sugars are the result of less physiologically
absorbed insulins whose peak of action is earlier or later than the peak absorption of
glucose from a meal.
Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of
action are ideal in that it may be administered more appropriately prior to and even after a
meal with evidence of good control of blood glucose excursions from a meal. The purpose of
this study is to compare the effect of Apidra upon meal related blood glucose profile as
compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. The
investigators also will study healthy volunteers as controls who will not be treated with
insulin but will be evaluated for mealtime absorption and blood glucose profile during
similar meal intake. The investigators will use a stable isotope tritiated glucose.
Intensive control of Type 1 Diabetes is critical in prevention of long term complications.
Unfortunately, there is a three-fold increase in hypoglycemia with intensive control.
Hypoglycemia is often the major limiting factor in achieving good control. Insulin treatment
of diabetes is composed of some form of short acting insulin regimen in order to provide
control of blood glucose excursions that are the result of glucose intake as well as a basal
insulin regimen either in a continuous administration (as in continuous subcutaneous insulin
infusion-"pump therapy"), once a day injection (insulin Glargine), twice a day (ultralente
or NPH or lente insulin) or a premixed version that is combined with the short acting
insulin (70/30 or 75/25). Often low blood sugars are the result of less physiologically
absorbed insulins whose peak of action is earlier or later than the peak absorption of
glucose from a meal.
Apidra (glulisine insulin) is a new short acting insulin analogue whose peak and duration of
action are ideal in that it may be administered more appropriately prior to and even after a
meal with evidence of good control of blood glucose excursions from a meal. The purpose of
this study is to compare the effect of Apidra upon meal related blood glucose profile as
compared to those treated with 70/30 insulin in patients with Type 1 Diabetes. We also will
study healthy volunteers as controls who will not be treated with insulin but will be
evaluated for mealtime absorption and blood glucose profile during similar meal intake. We
will use a stable isotope tritiated glucose.
;
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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