NCT00911625

Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency

Official Title:

Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency

Summary

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.

Eligibility

Inclusion Criteria:

* Type 2 Diabetes Mellitus of mor than 1year
* GFR less than 30 ml/min/1.73m2 or dialysis
* Age greater than 18years
* Entry blood glucose (fasting or random) greater than 180mg%

Exclusion Criteria:

* Type 1 Diabetes Mellitus
* New onset hyperglycemia
* Pregnant
* Solid organ transplant within 1 year
* Steroids prednisone greater than 7.5mg/day or equivalent
* Hospital LOS predicted less than 2 days
* Severe liver disease
* Known hypopituitarism or adrenal insufficiency
* Patients in the ICU
* Patients with hypoglycemic unawareness
* Outpatient insulin dose less than 0.6 units/kg

Disease(s) and\or Condition(s)

Type 2 Diabetes

Renal Insufficiency

Primary Purpose
  • TREATMENT
Intervention/Treatment
    • Type: DRUG
    • Name: 0.5 units/kg daily insulin
    • Description: Participants randomized to receive this intervention will receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
    • Arm Group Labels: 0.5 units/kg
    • Type: DRUG
    • Name: 0.25 units/kg daily insulin
    • Description: Participants randomized to receive this intervention will receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose will be given as glargine and the other half will be given as glulisine.
    • Arm Group Labels: 0.25 units/kg
Sponsor
  • Loyola University