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Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00338104
Enrollment
75
Registered
2006-06-20
Start date
2004-07-31
Completion date
2005-05-31
Last updated
2009-04-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Hyperglycemia

Keywords

insulin, glargine, intravenous, subcutaneous, hospital, diabetes, glucose, inpatient

Brief summary

The primary objective of this study is to determine the optimal dose of glargine insulin when converting from intravenous short-acting continuous insulin infusions in surgical and intensive care unit patients using a prospective, controlled, parallel group, randomized study design. Note: Lantus insulin is the proprietary name for glargine insulin.

Detailed description

Critical illness causes an impairment of insulin secretion and insulin action, resulting in hyperglycemia even in normal individuals and a worsening of the hyperglycemia in patients with diabetes. Normalization of elevated glucose levels by intensive insulin infusion therapy in these critically ill patients has been proven to dramatically improve in-hospital mortality rates. After glucose levels have been controlled with insulin infusions, the best way to convert them to subcutaneous insulin regimens has not been demonstrated conclusively but the insulin regimen best suited is a combination of a basal insulin such as glargine (Lantus) insulin with premeal insulin boluses using a short-acting insulin such as Lispro or Aspart. Subjects will be randomized into three groups, 25 subjects in each group, the groups differing according to the starting dose of glargine insulin as follows: 1. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.4 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion; 2. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.6 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion; 3. Multiply the total daily IV insulin dose, using the final 6 hour infusion rate to estimate the total daily dose, by 0.8 to get the starting dose of glargine, continuing the insulin drip for 5 hours after giving the glargine before stopping the infusion. The glargine insulin will then be continued as the basal insulin, adjusting doses every 24 hours based on the fasting blood glucose level. In addition, patients will receive Lispro or Aspart insulin as prandial bolus insulins with the goals premeal being 80 - 120 mg/dl, including bedtime. Glucose measurements will be obtained every 1- 4 hours while patients are on their insulin infusions, depending upon the stability of their condition and the stability of their glucose levels. Following transfer to glargine insulin, they will have glucose measured at least four times per day, premeal and bedtime as per standard protocol in the hospital for patients receiving insulin. Glucose data will be obtained from such patients and this will be compared among the various glargine regimens.

Interventions

DRUGinsulin glargine

Insulin glargine given at 40% of prior stable drip rate.

Sponsors

Sanofi
CollaboratorINDUSTRY
Northwestern University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Fasting glucose \> 100 mg/dl * Patients on surgical services or in intensive care units receiving intravenous insulin

Exclusion criteria

* Inability to obtain informed consent from patient or next-of-kin * Allergy to insulin * Participation in another research study * Patients for whom there are do-not-resuscitate orders

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Blood Glucose Values Between 80 - 140First 24 hours after conversionPercentage of blood glucose values within the target range of eighty to one hundred forty mg per dL

Secondary

MeasureTime frameDescription
Percentage of Glucose Values < 50 mg/dLFirst 24 hours after conversionPercentage of blood glucose values \< 50 mg/dL
Percentage of Glucose Levels > 180 mg/dLFirst 24 hours after conversionPercentage of blood glucose levels \> 180 mg/dL

Countries

United States

Participant flow

Recruitment details

75 patients with hyperglycemia were recruited from the inpatient service at Northwestern Memorial Hospital between August, 2004 and May, 2005.

Pre-assignment details

Patients had to be on a continuous insulin infusion to treat hyperglycemia prior to randomization

Participants by arm

ArmCount
40% Group
Glargine at 40% of insulin drip rate
25
60% Group
Glargine at 60% of insulin drip rate
25
80% Group
Glargine at 80% of insulin drip rate
25
Total75

Withdrawals & dropouts

PeriodReasonFG000FG001FG002
Overall StudyProtocol Violation213

Baseline characteristics

CharacteristicTotal40% Group60% Group80% Group
Age Continuous60.2 years
STANDARD_DEVIATION 11.7
61.4 years
STANDARD_DEVIATION 13.7
60.7 years
STANDARD_DEVIATION 10.8
58.6 years
STANDARD_DEVIATION 10.2
Body Mass Index29.8 kg/m2
STANDARD_DEVIATION 6.6
28.9 kg/m2
STANDARD_DEVIATION 5
30.6 kg/m2
STANDARD_DEVIATION 6.4
29.9 kg/m2
STANDARD_DEVIATION 8
Sex: Female, Male
Female
19 Participants5 Participants7 Participants7 Participants
Sex: Female, Male
Male
56 Participants20 Participants18 Participants18 Participants

Outcome results

Primary

Percentage of Blood Glucose Values Between 80 - 140

Percentage of blood glucose values within the target range of eighty to one hundred forty mg per dL

Time frame: First 24 hours after conversion

ArmMeasureValue (NUMBER)
40% GroupPercentage of Blood Glucose Values Between 80 - 14043 percentage of blood glucose values
60% GroupPercentage of Blood Glucose Values Between 80 - 14035 percentage of blood glucose values
80% GroupPercentage of Blood Glucose Values Between 80 - 14048 percentage of blood glucose values
Secondary

Percentage of Glucose Levels > 180 mg/dL

Percentage of blood glucose levels \> 180 mg/dL

Time frame: First 24 hours after conversion

ArmMeasureValue (NUMBER)
40% GroupPercentage of Glucose Levels > 180 mg/dL19 percentage of blood glucose values
60% GroupPercentage of Glucose Levels > 180 mg/dL34 percentage of blood glucose values
80% GroupPercentage of Glucose Levels > 180 mg/dL18 percentage of blood glucose values
Secondary

Percentage of Glucose Values < 50 mg/dL

Percentage of blood glucose values \< 50 mg/dL

Time frame: First 24 hours after conversion

ArmMeasureValue (NUMBER)
40% GroupPercentage of Glucose Values < 50 mg/dL1 percentage of blood glucose values
60% GroupPercentage of Glucose Values < 50 mg/dL0 percentage of blood glucose values
80% GroupPercentage of Glucose Values < 50 mg/dL0 percentage of blood glucose values

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026