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

Completed · Phase 4

Conditions studied: Type 2 Diabetes, Renal Insufficiency

In brief

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.

Key facts

Study ID

NCT00911625

Run by

Loyola University

People needed

114

Starts

2009-01-21

Expected to finish

2011-06-30

Last updated by the study team

2017-04-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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%

You may not qualify if…

• 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

Where it is running

• Northwestern University Medical Center — Chicago, Illinois, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Loyola University Hospital — Maywood, Illinois, United States

Full record on ClinicalTrials.gov

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