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Trial record 2 of 4 for:    18308683 [PUBMED-IDS]

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

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ClinicalTrials.gov Identifier: NCT00911625
Recruitment Status : Completed
First Posted : June 2, 2009
Results First Posted : March 10, 2017
Last Update Posted : April 6, 2017
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Mary Ann Emanuele, Loyola University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Type 2 Diabetes
Renal Insufficiency
Interventions Drug: 0.5 units/kg daily insulin
Drug: 0.25 units/kg daily insulin
Enrollment 114
Recruitment Details Recruitment for this study took place at Loyola University Medical Center (Maywood, IL), Rush University Medical Center (Chicago, IL), and Northwestern University Medical Center (Chicago, IL) between January 2009 and May 2011
Pre-assignment Details  
Arm/Group Title 0.5 Units/kg 0.25 Units/kg
Hide Arm/Group Description Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine. Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
Period Title: Overall Study
Started 57 57
Completed 50 57
Not Completed 7 0
Reason Not Completed
Lost to Follow-up             7             0
Arm/Group Title 0.5 Units/kg 0.25 Units/kg Total
Hide Arm/Group Description

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.

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.

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.

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.

Total of all reporting groups
Overall Number of Baseline Participants 50 57 107
Hide Baseline Analysis Population Description
The baseline analysis population comprises all patients who were randomized and completed all study activities
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 57 participants 107 participants
65.3  (10.6) 63.7  (13.0) 64.0  (11.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 57 participants 107 participants
Female
30
  60.0%
28
  49.1%
58
  54.2%
Male
20
  40.0%
29
  50.9%
49
  45.8%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 57 participants 107 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
1
   1.8%
1
   0.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
17
  34.0%
22
  38.6%
39
  36.4%
White
32
  64.0%
32
  56.1%
64
  59.8%
More than one race
1
   2.0%
2
   3.5%
3
   2.8%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Glomerular filtration rate  
Mean (Standard Deviation)
Unit of measure:  mL/min/1.73 squared meters
Number Analyzed 50 participants 57 participants 107 participants
30.4  (8.3) 29.6  (10) 29.9  (9.0)
Years of Diabetes  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 50 participants 57 participants 107 participants
18.6  (8.8) 16.6  (9.9) 17.6  (10.0)
Glycated hemoglobin  
Mean (Standard Deviation)
Unit of measure:  Percentage (%)
Number Analyzed 50 participants 57 participants 107 participants
8.2  (2.1) 7.9  (1.9) 8.0  (2.0)
Insulin therapy before admission  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 50 participants 57 participants 107 participants
Insulin before admission
39
  78.0%
42
  73.7%
81
  75.7%
No insulin before admission
11
  22.0%
15
  26.3%
26
  24.3%
Total home daily insulin dose  
Mean (Standard Deviation)
Unit of measure:  Units of insulin
Number Analyzed 50 participants 57 participants 107 participants
54.3  (40.7) 51.6  (46.3) 52.0  (43.0)
1.Primary Outcome
Title Average Blood Glucose Over 6 Days
Hide Description 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.
Time Frame 6 Days
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis population for the primary outcome comprises all participants who were randomized and completed all study activities
Arm/Group Title 0.5 Units/kg 0.25 Units/kg
Hide Arm/Group Description:
Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
Overall Number of Participants Analyzed 50 57
Mean (Standard Deviation)
Unit of Measure: milligrams per deciliter
174  (52.3) 174.5  (46)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.5 Units/kg, 0.25 Units/kg
Comments The null hypothesis is that there is no difference between the two treatment cohorts on their average blood glucose level
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .958
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -0.50
Confidence Interval (2-Sided) 95%
-19.341 to 18.341
Parameter Dispersion
Type: Standard Error of the Mean
Value: 9.502
Estimation Comments [Not Specified]
2.Secondary Outcome
Title The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter
Hide Description 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
Time Frame 6 Days
Hide Outcome Measure Data
Hide Analysis Population Description
This analysis comprises all participants who were randomized and completed all study activities
Arm/Group Title 0.5 Units/kg 0.25 Units/kg
Hide Arm/Group Description:
Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
Overall Number of Participants Analyzed 50 57
Measure Type: Count of Participants
Unit of Measure: Participants
At least one blood glucose level below 70 mg/dL
15
  30.0%
9
  15.8%
No blood glucose level below 70 mg/dL
35
  70.0%
48
  84.2%
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 0.5 Units/kg, 0.25 Units/kg
Comments The null hypothesis is that there is no difference in the odds of experiencing at least one blood glucose level below 70 mg/dL between the two treatment cohorts.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .0828
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 0.438
Confidence Interval (2-Sided) 95%
0.172 to 1.114
Estimation Comments [Not Specified]
Time Frame Adverse event data were collected for 2 years, 3 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 0.5 Units/kg 0.25 Units/kg
Hide Arm/Group Description Participants randomized to this arm receive a standard-dose of 0.5 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine. Participants randomized to this arm receive an experimental dose of 0.25 units/kg daily insulin. Half of this dose is given as glargine and the other half as glulisine.
All-Cause Mortality
0.5 Units/kg 0.25 Units/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
0.5 Units/kg 0.25 Units/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
0.5 Units/kg 0.25 Units/kg
Affected / at Risk (%) Affected / at Risk (%)
Total   0/57 (0.00%)   0/57 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: David Baldwin, MD
Organization: Rush University Medical Center
Phone: 312-942-2813
EMail: david_baldwin@rush.edu
Publications:
Layout table for additonal information
Responsible Party: Mary Ann Emanuele, Loyola University
ClinicalTrials.gov Identifier: NCT00911625     History of Changes
Other Study ID Numbers: 201463
First Submitted: May 29, 2009
First Posted: June 2, 2009
Results First Submitted: January 22, 2017
Results First Posted: March 10, 2017
Last Update Posted: April 6, 2017