Trial Outcomes & Findings for Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir (NCT NCT00717288)

NCT ID: NCT00717288

Last Updated: 2011-10-03

Results Overview

Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 82 participants
• Primary outcome timeframe: day 2, day 3
• Results posted on: 2011-10-03

Participant Flow

Participant milestones

Measure	50% Conversion Factor Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	65% Conversion Factor Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	80% Conversion Factor Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Overall Study STARTED	28	29	25
Overall Study COMPLETED	28	29	25
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

Baseline characteristics by cohort

Measure	50% Conversion Factor n=28 Participants Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	65% Conversion Factor n=29 Participants Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	80% Conversion Factor n=25 Participants Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily	Total n=82 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	24 Participants n=7 Participants	19 Participants n=5 Participants	65 Participants n=4 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants	17 Participants n=4 Participants
Age Continuous	58 years STANDARD_DEVIATION 8.0 • n=5 Participants	57 years STANDARD_DEVIATION 9.1 • n=7 Participants	61 years STANDARD_DEVIATION 7.6 • n=5 Participants	58.7 years STANDARD_DEVIATION 8.4 • n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants	17 Participants n=4 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	25 Participants n=7 Participants	17 Participants n=5 Participants	65 Participants n=4 Participants
Region of Enrollment United States	28 participants n=5 Participants	29 participants n=7 Participants	25 participants n=5 Participants	82 participants n=4 Participants

PRIMARY outcome

Timeframe: day 2, day 3

Population: intention to treat (ITT)

Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3

Outcome measures

Measure	50% Conversion Factor n=28 Participants Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	65% Conversion Factor n=29 Participants Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	80% Conversion Factor n=25 Participants Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3	10 participants	18 participants	14 participants

SECONDARY outcome

Timeframe: 48 hours

Population: Intention to treat (ITT)

Number of patients with hypoglycemia (defined as glucose <65 mg/dl)

Outcome measures

Measure	50% Conversion Factor n=28 Participants Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	65% Conversion Factor n=29 Participants Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	80% Conversion Factor n=25 Participants Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)	0 participants	6 participants	3 participants

SECONDARY outcome

Timeframe: 72 hours

Number of participants who went back on intravenous insulin for failure of glycemic control.

Outcome measures

Measure	50% Conversion Factor n=28 Participants Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	65% Conversion Factor n=29 Participants Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	80% Conversion Factor n=25 Participants Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Reversion to Intravenous Insulin for Failure of Glycemic Control	2 participants	0 participants	1 participants

Adverse Events

50% Conversion Factor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

65% Conversion Factor

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

80% Conversion Factor

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	50% Conversion Factor n=28 participants at risk Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	65% Conversion Factor n=29 participants at risk Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	80% Conversion Factor n=25 participants at risk Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
General disorders Death	0.00% 0/28	0.00% 0/28	4.0% 1/25 • Number of events 1

Other adverse events

Measure	50% Conversion Factor n=28 participants at risk Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	65% Conversion Factor n=29 participants at risk Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	80% Conversion Factor n=25 participants at risk Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Endocrine disorders BG <40 mg/dl	0.00% 0/28	0.00% 0/29	4.0% 1/25 • Number of events 1

Additional Information

Kathleen Dungan, MD

The Ohio State University

Phone: 614-292-3800

Email: kathleen.dungan@osumc.edu

Results disclosure agreements

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