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

March 9, 2017 updated by: Mary Ann Emanuele, Loyola University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

114

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University Medical Center
      • Maywood, Illinois, United States, 60153
        • Loyola University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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
6 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Collaborators

Sanofi

Investigators

  • Principal Investigator: Mary Ann Emanuele, MD, Loyola University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2009

Primary Completion (Actual)

June 30, 2011

Study Completion (Actual)

June 30, 2011

Study Registration Dates

First Submitted

May 29, 2009

First Submitted That Met QC Criteria

June 1, 2009

First Posted (Estimate)

June 2, 2009

Study Record Updates

Last Update Posted (Actual)

April 6, 2017

Last Update Submitted That Met QC Criteria

March 9, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201463

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There are no plans to make individual participant data available to other researchers

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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