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
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Insulin glulisine; Insulin
Intervention type(s): Drug; Drug
Intervention description(s): Dose injection of insulin glargine (Lantus®) given subcutaneously in the abdomen 1 hour prior to breakfast and a dose of insulin glulisine (Apidra®) at a dose based upon your (body wt.) carbohydrate intake for each of the three meals (breakfast, lunch and dinner).; Dose based on carbohydrate intake given subcutaneously in the abdomen prior to breakfast and dinner.
Other intervention name(s): Apidra; Humalog 70/30
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin glulisine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Insulin analogs; diabetes