Trial Outcomes & Findings for Perioperative Insulin Glargine Dosing Study (NCT NCT00309465)
NCT ID: NCT00309465
Last Updated: 2012-12-03
Results Overview
Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
402 participants
Primary outcome timeframe
Day 1
Results posted on
2012-12-03
Participant Flow
Recruitment at William Beaumont Heath System Royal Oak and Troy campuses commenced in October 2005 and was completed in September 2008.
Subjects were stratified into groups (insulin glargine only group and insulin glargine plus bolus group) by the absence or presence of daily rapid-acting (or short-acting) insulin in regimen. The two groups were then randomized into Take 80%, Call Physician or Dose Table strategies. One subject was excluded from analysis due to eligibility error.
Participant milestones
| Measure |
Take 80% (Insulin Glargine Only Group)
Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
|
Call Physician (Insulin Glargine Only Group)
Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
|
Dose Table (Insulin Glargine Only Group)
Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose value was \< 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was \> or = 150 mg/dl.
|
Take 80% (Insulin Glargine Plus Bolus Group)
Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
|
Call Physician (Insulin Glargine Plus Bolus Group
Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
|
Dose Table (Insulin Glargine Plus Bolus Group)
Subjects were instructed to self-administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose value was \<150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was \> or = 150 mg/dl.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
58
|
58
|
58
|
76
|
76
|
76
|
|
Overall Study
COMPLETED
|
58
|
58
|
58
|
75
|
76
|
76
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Perioperative Insulin Glargine Dosing Study
Baseline characteristics by cohort
| Measure |
Take 80% (Insulin Glargine Only Group)
n=58 Participants
Subjects were instructed to self-administer 80% of the usual insulin glargine dose on the evening before surgery.
|
Call Physician (Insulin Glargine Only Group)
n=58 Participants
Subjects were instructed to call their physician for the insulin glargine dose to administer the evening before surgery.
|
Dose Table (Insulin Glargine Only Group)
n=58 Participants
Subjects were instructed to self-administer: (a) 50% of their usual insulin glargine if the midpoint of their usual self-reported fasting blood glucose range was \< 150 mg/dl or (b) 80% of their usual insulin glargine if the midpoint of their usual fasting blood glucose range was \> or = 150 mg/dl.
|
Take 80% (Insulin Glargine Plus Bolus Group)
n=75 Participants
Subjects were instructed to self-administer 80% of the usual insulin glargine dose the evening before surgery
|
Call Physician (Insulin Glargine Plus Bolus Group
n=76 Participants
Subjects were instructed to call their own physician for the insulin glargine dose to administer the evening before surgery.
|
Dose Table (Insulin Glargine Plus Bolus Group)
n=76 Participants
Subjects were instructed to self administer: (a) 80% of the usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was \<150 mg/dl or (b) 100% of the usual insulin glargine dose if the midpoint of the self-reported usual fasting blood glucose range was \> or = 150 mg/dl.
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
37 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
52 Participants
n=483 Participants
|
53 Participants
n=36 Participants
|
52 Participants
n=10 Participants
|
259 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
21 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
23 Participants
n=483 Participants
|
23 Participants
n=36 Participants
|
24 Participants
n=10 Participants
|
142 Participants
n=115 Participants
|
|
Age Continuous
|
60.1 years
STANDARD_DEVIATION 10.0 • n=93 Participants
|
61.5 years
STANDARD_DEVIATION 11.4 • n=4 Participants
|
63.1 years
STANDARD_DEVIATION 11.6 • n=27 Participants
|
55.8 years
STANDARD_DEVIATION 15.9 • n=483 Participants
|
58.4 years
STANDARD_DEVIATION 12.0 • n=36 Participants
|
57.3 years
STANDARD_DEVIATION 13.3 • n=10 Participants
|
59.1 years
STANDARD_DEVIATION 12.5 • n=115 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=93 Participants
|
27 Participants
n=4 Participants
|
28 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
41 Participants
n=36 Participants
|
38 Participants
n=10 Participants
|
207 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
30 Participants
n=27 Participants
|
32 Participants
n=483 Participants
|
35 Participants
n=36 Participants
|
38 Participants
n=10 Participants
|
194 Participants
n=115 Participants
|
|
Region of Enrollment
United States
|
58 participants
n=93 Participants
|
58 participants
n=4 Participants
|
58 participants
n=27 Participants
|
75 participants
n=483 Participants
|
76 participants
n=36 Participants
|
76 participants
n=10 Participants
|
401 participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Percentage of subjects that achieved preoperative blood glucose value of 100-179 mg/dl and 80-249 mg/dl. Analyses were by intention to treat.
Venous blood glucose values were obtained in the preoperative nursing unit. Blood glucose values were analyzed for achievement of target 100-179 mg/dl range and extended 80-249 mg/dl range. Analyses were by intention to treat.
Outcome measures
| Measure |
Take 80% (Insulin Glargine Only Group)
n=58 Participants
Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
|
Call Physician (Insulin Glargine Only Group)
n=58 Participants
Subjects called their own physicians for insulin glargine dose on the evening before surgery
|
Dose Table (Insulin Glargine Only Group)
n=58 Participants
Subjects administered: (a) 50% of their usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was \<150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose range was \> or = 150 mg/dl
|
Take 80% (Insulin Glargine Plus Bolus Group)
n=75 Participants
Subjects self-administered 80% of the usual insulin glargine dose on the evening before surgery
|
Call Physician (Insulin Glargine Plus Bolus Group
n=76 Participants
Subjects called their own physicians for the insulin glargine dose to administer on the evening before surgery
|
Dose Table (Insulin Glargine Plus Bolus Group)
n=76 Participants
Subjects administered: (a) 80% of their usual insulin glargine dose if the midpoint of self-reported usual fasting blood glucose range was \<150 mg/dl or (b) 100% of their usual insulin glargine dose if midpoint of self-reported usual fasting blood glucose ragne was \> or = 150 mg/dl
|
|---|---|---|---|---|---|---|
|
Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery
Achievement of 100-179 mg/dl
|
58.6 Percentage of subjects
|
72.4 Percentage of subjects
|
74.1 Percentage of subjects
|
58.7 Percentage of subjects
|
52.6 Percentage of subjects
|
63.2 Percentage of subjects
|
|
Primary: Preoperative Fasting Blood Sugar Upon Arrival at the Hospital Prior to Surgery
Achievement of 80-249 mg/dl
|
89.7 Percentage of subjects
|
89.7 Percentage of subjects
|
98.3 Percentage of subjects
|
81.3 Percentage of subjects
|
81.6 Percentage of subjects
|
93.4 Percentage of subjects
|
Adverse Events
Take 80% (Insulin Glargine Only Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Call Physician (Insulin Glargine Only Group)
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Table (Insulin Glargine Only Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Take 80% (Insuling Glargine Plus Bolus Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Call Physician (Insulin Glargine Plus Bolus Group)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Table (Insulin Glargine Plus Bolus Group)
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Take 80% (Insulin Glargine Only Group)
n=58 participants at risk
Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
|
Call Physician (Insulin Glargine Only Group)
n=58 participants at risk
Subjects called physician for the insulin glargine dose on the evening before surgery.
|
Dose Table (Insulin Glargine Only Group)
n=58 participants at risk
Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose \<150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose \> or =150 mg/dl
|
Take 80% (Insuling Glargine Plus Bolus Group)
n=75 participants at risk
Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
|
Call Physician (Insulin Glargine Plus Bolus Group)
n=76 participants at risk
Subjects called physician for the insulin glargine dose to administer on the evening before surgery.
|
Dose Table (Insulin Glargine Plus Bolus Group)
n=76 participants at risk
Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was \<150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was \< or =150 mg/dl.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Severe Hyperglycemia resulting in surgery cancellation
|
0.00%
0/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
1.7%
1/58 • Number of events 1 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/75 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/76 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/76 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
Other adverse events
| Measure |
Take 80% (Insulin Glargine Only Group)
n=58 participants at risk
Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
|
Call Physician (Insulin Glargine Only Group)
n=58 participants at risk
Subjects called physician for the insulin glargine dose on the evening before surgery.
|
Dose Table (Insulin Glargine Only Group)
n=58 participants at risk
Subjects administered: (a) 50% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose \<150 mg/dl or (b) 80% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose \> or =150 mg/dl
|
Take 80% (Insuling Glargine Plus Bolus Group)
n=75 participants at risk
Subjects self-administered 80% of usual insulin glargine dose on the evening before surgery
|
Call Physician (Insulin Glargine Plus Bolus Group)
n=76 participants at risk
Subjects called physician for the insulin glargine dose to administer on the evening before surgery.
|
Dose Table (Insulin Glargine Plus Bolus Group)
n=76 participants at risk
Subjects administered: (a) 80% of usual insulin glargine if midpoint of usual self-reported fasting blood glucose was \<150 mg/dl or (b) 100% of usual insulin glargine dose if midpoint of usual self-reported fasting blood glucose was \< or =150 mg/dl.
|
|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Moderate Hypoglycemia
|
1.7%
1/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/75 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/76 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
1.3%
1/76 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
|
Metabolism and nutrition disorders
Severe hyperglycemia without surgery cancellation
|
0.00%
0/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/58 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
1.3%
1/75 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/76 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
0.00%
0/76 • Adverse event data was collected for the preoperative period on the day of surgery. Severe hyperglycemia resulting in surgery cancellation and severe hypoglycemia resulting in loss of consciousness were defined as severe adverse events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place