Trial Outcomes & Findings for Conversion of Hyperglycemic Patients Being Treated With Intravenous Insulin Infusions to Lantus Insulin (NCT NCT00338104)

NCT ID: NCT00338104

Last Updated: 2009-04-06

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 75 participants
• Primary outcome timeframe: First 24 hours after conversion
• Results posted on: 2009-04-06

Participant Flow

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

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

Participant milestones

Measure	40% Group Glargine at 40% of insulin drip rate	60% Group Glargine at 60% of insulin drip rate	80% Group Glargine at 80% of insulin drip rate
Overall Study STARTED	25	25	25
Overall Study COMPLETED	23	24	22
Overall Study NOT COMPLETED	2	1	3

Reasons for withdrawal

Measure	40% Group Glargine at 40% of insulin drip rate	60% Group Glargine at 60% of insulin drip rate	80% Group Glargine at 80% of insulin drip rate
Overall Study Protocol Violation	2	1	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	40% Group n=25 Participants Glargine at 40% of insulin drip rate	60% Group n=25 Participants Glargine at 60% of insulin drip rate	80% Group n=25 Participants Glargine at 80% of insulin drip rate	Total n=75 Participants Total of all reporting groups
Age Continuous	61.4 years STANDARD_DEVIATION 13.7 • n=5 Participants	60.7 years STANDARD_DEVIATION 10.8 • n=7 Participants	58.6 years STANDARD_DEVIATION 10.2 • n=5 Participants	60.2 years STANDARD_DEVIATION 11.7 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants	19 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	18 Participants n=7 Participants	18 Participants n=5 Participants	56 Participants n=4 Participants
Body Mass Index	28.9 kg/m2 STANDARD_DEVIATION 5.0 • n=5 Participants	30.6 kg/m2 STANDARD_DEVIATION 6.4 • n=7 Participants	29.9 kg/m2 STANDARD_DEVIATION 8.0 • n=5 Participants	29.8 kg/m2 STANDARD_DEVIATION 6.6 • n=4 Participants

PRIMARY outcome

Timeframe: First 24 hours after conversion

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

Outcome measures

Measure	40% Group n=23 Participants Glargine at 40% of insulin drip rate	60% Group n=24 Participants Glargine at 60% of insulin drip rate	80% Group n=22 Participants Glargine at 80% of insulin drip rate
Percentage of Blood Glucose Values Between 80 - 140	43 percentage of blood glucose values	35 percentage of blood glucose values	48 percentage of blood glucose values

SECONDARY outcome

Timeframe: First 24 hours after conversion

Percentage of blood glucose values < 50 mg/dL

Outcome measures

Measure	40% Group n=23 Participants Glargine at 40% of insulin drip rate	60% Group n=24 Participants Glargine at 60% of insulin drip rate	80% Group n=22 Participants Glargine at 80% of insulin drip rate
Percentage of Glucose Values < 50 mg/dL	1 percentage of blood glucose values	0 percentage of blood glucose values	0 percentage of blood glucose values

SECONDARY outcome

Timeframe: First 24 hours after conversion

Percentage of blood glucose levels > 180 mg/dL

Outcome measures

Measure	40% Group n=23 Participants Glargine at 40% of insulin drip rate	60% Group n=24 Participants Glargine at 60% of insulin drip rate	80% Group n=22 Participants Glargine at 80% of insulin drip rate
Percentage of Glucose Levels > 180 mg/dL	19 percentage of blood glucose values	34 percentage of blood glucose values	18 percentage of blood glucose values

Adverse Events

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Mark E. Molitch, M.D.

Northwestern University

Phone: 312 503-4130

Email: molitch@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place