Type 2 Diabetes Clinical Trial
Official title:
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
It is imperative to devise easy to follow, yet appropriate, guidelines for insulin use in renal-impaired patients. This will be done by comparing two regimens: 1) glargine once daily plus mealtime glulisine based on weight alone and 2) a predetermined dosing reduction algorithm with glargine/glulisine based on weight with reduction for decreased estimated GFR by MDRD as follows: < 30 ml/min/1.73m2 or on dialysis reduce dose by 50% from weight based calculation.
This study will enroll 180 hospitalized patients with Type 2 diabetes and moderate to end
stage renal insufficiency (estimated glomerular filtration rate is < 30 ml/min/1.73m2 or
dialysis) in the Chicagoland area. Participants will be randomized into 1 of 2 protocols
after hospital admission. Blood glucose levels will be obtained before meals, at bedtime and
whenever necessary for any signs or symptoms of hypoglycemia. The primary endpoint will be
the percentage of blood glucose levels reaching goal of 80-180mg/dl. A secondary endpoint
will be the percentage of hypoglycemic events, defined as blood glucose values < 60 mg/dl.
In addition the percentage of glucose levels within the goal range of 80-180mg.dl will be
further separated into excellent control (80-140mg/dl) and acceptable control
(141-180mg/dl).
The 2 study groups will be:
1. Glargine & glulisine. The total daily insulin dose will be 0.6 units/kg. Half of this
will be given as glargine once daily. The other half will be given as glulisine,
divided equally between breakfast, lunch, and dinner with correction factor dosing as
needed for elevated premeal hyperglycemia.
2. Glargine & glulisine The calculation for the total daily insulin dose will be 0.3
units/kg. Half of this will be given as glargine in the morning. The other half will be
given as glulisine, divided equally between breakfast, lunch, and dinner, with
correction factor dosing as needed for elevated premeal hyperglycemia.
All oral agents will be discontinued on admission.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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