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

• Status: Completed
• Trial end date: 2011-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Loyola University
• Collaborator: Sanofi
• Treatments: Insulin; Insulin Glargine; Insulin glulisine; Insulin, Globin Zinc

Criteria

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