Clinical trial 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Renal Insufficiency
Keywords: glargine
glulisine
type 2 diabetes
renal insufficiency
Lead sponsor: Loyola University
Sponsor class: OTHER
Collaborators: name: Sanofi
First posted: 2009-06-02
Enrollment: 114
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible participants are randomized to one of the two dosing groups using a 1:1 allocation
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Average Blood Glucose Over 6 Days
timeFrame: 6 Days
Secondary outcomes:
measure: The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter
timeFrame: 6 Days
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern University Medical Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: Maywood
country: United States
facility: Loyola University Hospital
state: Illinois
Study officials:
affiliation: Loyola University
name: Mary Ann Emanuele, MD
role: PRINCIPAL_INVESTIGATOR
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