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

Study Overview
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Brief Summary
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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
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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: 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. 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.

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

Conditions
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Type 2 Diabetes, Renal Insufficiency

Intervention / Treatment
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* Drug: 0.5 units/kg daily insulin
* Drug: 0.25 units/kg daily insulin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Eligible participants are randomized to one of the two dosing groups using a 1:1 allocation
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 0.5 units/kg<br>Participants randomized to this arm 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. | Drug: 0.5 units/kg daily insulin<br>* 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.<br>* Other names: Apidra;|
| Experimental: 0.25 units/kg<br>Participants randomized to this arm 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. | Drug: 0.25 units/kg daily insulin<br>* 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.<br>* Other names: Apidra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Blood Glucose Over 6 Days | Participants have their blood glucose measured daily for six days. The average blood glucose measure over all six days is compared between the two treatment cohorts. | 6 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter | At the end of the study, the number of participants who experience at least one blood glucose level below 70 milligrams per deciliter (mg/dL) is compared between the two treatment cohorts | 6 Days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glargine, glulisine, type 2 diabetes, renal insufficiency