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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00911625
• Other study ID #: 201463
• Status: Completed
• Phase: Phase 4
• First received: May 29, 2009
• Last updated: September 11, 2016
• Start date: May 2009
• Est. completion date: September 2013

Study information

• Verified date: September 2016
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Renal Insufficiency
• Type 2 Diabetes

Intervention

Drug:
• Glargine & glulisine (high dose)
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
• Glargine & glulisine low dose
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

Locations

Country	Name	City	State
United States	Northwestern University Medical Center	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Loyola University Hospital	Maywood	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Loyola University	Sanofi

Country where clinical trial is conducted

United States, 

References & Publications (1)

Baldwin D, Zander J, Munoz C, Raghu P, DeLange-Hudec S, Lee H, Emanuele MA, Glossop V, Smallwood K, Molitch M. A randomized trial of two weight-based doses of insulin glargine and glulisine in hospitalized subjects with type 2 diabetes and renal insufficiency. Diabetes Care. 2012 Oct;35(10):1970-4. Epub 2012 Jun 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine if a glargine based regime with dose reduction for renal insufficiency is more efficacious than a glargine regime without such a reduction in hospitalized patients.		7-10 days	No
Secondary	To determine the relative safety of each of the regimes in avoidance of hypoglycemia.		7-10 days	Yes