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

This study is currently recruiting participants.
Verified October 2012 by Loyola University
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00911625
First received: May 29, 2009
Last updated: October 29, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Type 2 Diabetes
Renal Insufficiency
Drug: Glargine & glulisine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • 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. [ Time Frame: 7-10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To determine the relative safety of each of the regimes in avoidance of hypoglycemia. [ Time Frame: 7-10 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 180
Study Start Date: May 2009
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Arm 1 Glargine & glulisine
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
Drug: Glargine & glulisine
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
Other Names:
  • Lantus
  • Apidra
Active Comparator: Arm 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
Drug: Glargine & glulisine
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
Other Names:
  • Lantus
  • Apidra

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00911625

Contacts
Contact: Barbara Sexton, RN 708-216-8223 bsexton@lumc.edu

Locations
United States, Illinois
Rush University Medical Center Recruiting
Chicago, Illinois, United States
Contact: David Baldwin, MD    312-942-2813      
Sub-Investigator: David Baldwin, MD         
Northwestern University Medical Center Recruiting
Chicago, Illinois, United States
Contact: Mark Molitch, MD    312-503-4130      
Sub-Investigator: Mark Molitch, MD         
Loyola University Hospital Recruiting
Maywood, Illinois, United States, 60153
Contact: Barbara Sexton    708-216-8223    bsexton@lumc.edu   
Principal Investigator: Mary Ann Emanuele, MD         
Sponsors and Collaborators
Loyola University
Sanofi
Investigators
Principal Investigator: Mary Ann Emanuele, MD Loyola University
  More Information

No publications provided by Loyola University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Loyola University
ClinicalTrials.gov Identifier: NCT00911625     History of Changes
Other Study ID Numbers: 201463
Study First Received: May 29, 2009
Last Updated: October 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
glargine
glulisine
type 2 diabetes
renal insufficiency

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Kidney Diseases
Urologic Diseases
Glargine
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 16, 2014