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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Mary Ann Emanuele, Loyola University
ClinicalTrials.gov Identifier:
NCT00911625
First received: May 29, 2009
Last updated: March 9, 2017
Last verified: March 2017
  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: 0.5 units/kg daily insulin
Drug: 0.25 units/kg daily insulin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Eligible participants are randomized to one of the two dosing groups using a 1:1 allocation
Masking: No masking
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:
  • Average Blood Glucose Over 6 Days [ Time Frame: 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.


Secondary Outcome Measures:
  • The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter [ Time Frame: 6 Days ]
    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


Enrollment: 114
Actual Study Start Date: January 21, 2009
Study Completion Date: June 30, 2011
Primary Completion Date: June 30, 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 0.5 units/kg
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
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.
Other Names:
  • Lantus
  • Apidra
Experimental: 0.25 units/kg
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
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.
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911625

Locations
United States, Illinois
Northwestern University Medical Center
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
Loyola University Hospital
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Sanofi
Investigators
Principal Investigator: Mary Ann Emanuele, MD Loyola University
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Mary Ann Emanuele, Professor of Medicine, Loyola University
ClinicalTrials.gov Identifier: NCT00911625     History of Changes
Other Study ID Numbers: 201463
Study First Received: May 29, 2009
Results First Received: January 22, 2017
Last Updated: March 9, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There are no plans to make individual participant data available to other researchers

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

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
Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Glargine
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 28, 2017