Trial Outcomes & Findings for Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency (NCT NCT00911625)
NCT ID: NCT00911625
Last Updated: 2017-04-06
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
114 participants
Primary outcome timeframe
6 Days
Results posted on
2017-04-06
Participant Flow
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
Participant milestones
| Measure |
0.5 Units/kg
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.
|
0.25 Units/kg
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 Study
STARTED
|
57
|
57
|
|
Overall Study
COMPLETED
|
50
|
57
|
|
Overall Study
NOT COMPLETED
|
7
|
0
|
Reasons for withdrawal
| Measure |
0.5 Units/kg
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.
|
0.25 Units/kg
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 Study
Lost to Follow-up
|
7
|
0
|
Baseline Characteristics
Glargine Dosing in Hospitalized Patients With Type 2 Diabetes and Renal Insufficiency
Baseline characteristics by cohort
| Measure |
0.5 Units/kg
n=50 Participants
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.
|
0.25 Units/kg
n=57 Participants
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
n=107 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.3 years
STANDARD_DEVIATION 10.6 • n=93 Participants
|
63.7 years
STANDARD_DEVIATION 13.0 • n=4 Participants
|
64.0 years
STANDARD_DEVIATION 11.0 • n=27 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
28 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=93 Participants
|
29 Participants
n=4 Participants
|
49 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
39 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
32 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
64 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Glomerular filtration rate
|
30.4 mL/min/1.73 squared meters
STANDARD_DEVIATION 8.3 • n=93 Participants
|
29.6 mL/min/1.73 squared meters
STANDARD_DEVIATION 10 • n=4 Participants
|
29.9 mL/min/1.73 squared meters
STANDARD_DEVIATION 9.0 • n=27 Participants
|
|
Years of Diabetes
|
18.6 years
STANDARD_DEVIATION 8.8 • n=93 Participants
|
16.6 years
STANDARD_DEVIATION 9.9 • n=4 Participants
|
17.6 years
STANDARD_DEVIATION 10.0 • n=27 Participants
|
|
Glycated hemoglobin
|
8.2 Percentage (%)
STANDARD_DEVIATION 2.1 • n=93 Participants
|
7.9 Percentage (%)
STANDARD_DEVIATION 1.9 • n=4 Participants
|
8.0 Percentage (%)
STANDARD_DEVIATION 2.0 • n=27 Participants
|
|
Insulin therapy before admission
Insulin before admission
|
39 Participants
n=93 Participants
|
42 Participants
n=4 Participants
|
81 Participants
n=27 Participants
|
|
Insulin therapy before admission
No insulin before admission
|
11 Participants
n=93 Participants
|
15 Participants
n=4 Participants
|
26 Participants
n=27 Participants
|
|
Total home daily insulin dose
|
54.3 units of insulin
STANDARD_DEVIATION 40.7 • n=93 Participants
|
51.6 units of insulin
STANDARD_DEVIATION 46.3 • n=4 Participants
|
52.0 units of insulin
STANDARD_DEVIATION 43.0 • n=27 Participants
|
PRIMARY outcome
Timeframe: 6 DaysPopulation: The analysis population for the primary outcome comprises all participants who were randomized and completed all study activities
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.
Outcome measures
| Measure |
0.5 Units/kg
n=50 Participants
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.
|
0.25 Units/kg
n=57 Participants
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.
|
|---|---|---|
|
Average Blood Glucose Over 6 Days
|
174 milligrams per deciliter
Standard Deviation 52.3
|
174.5 milligrams per deciliter
Standard Deviation 46
|
SECONDARY outcome
Timeframe: 6 DaysPopulation: This analysis comprises all participants who were randomized and completed all study activities
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
Outcome measures
| Measure |
0.5 Units/kg
n=50 Participants
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.
|
0.25 Units/kg
n=57 Participants
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.
|
|---|---|---|
|
The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter
At least one blood glucose level below 70 mg/dL
|
15 Participants
|
9 Participants
|
|
The Number of Participants Who Experience at Least One Blood Glucose Level Below 70 Milligrams Per Deciliter
No blood glucose level below 70 mg/dL
|
35 Participants
|
48 Participants
|
Adverse Events
0.5 Units/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
0.25 Units/kg
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place