Transitioning Open Heart Surgery Patients From Insulin Infusions to Detemir

• Sponsor: Ohio State University (Other)
• Overall Status: Completed
• CT.gov ID: NCT00717288
• Collaborator: Novo Nordisk A/S (Industry)
• Enrollment: 82
• Location: 1
• Arms: 3
• Duration (Months): 23
• Patients Per Site Per Month: 3.6

Study Details

Study Description

Brief Summary

In this study we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir).

Condition or Disease	Intervention/Treatment	Phase
Diabetes Mellitus	Drug: Detemir; Drug: Detemir; Drug: Detemir	Phase 4

Detailed Description

High sugar (glucose) is common after surgery, even in patients who do not have diabetes. High glucose contributes to severe hospital complications and even death. Insulin infusions appear to reduce this risk, but are generally only continued for a few days after surgery. In this study, we will determine the proper method for transitioning patients from a continuous insulin infusion to periodic injections of a newer long-acting insulin called detemir (Levemir). 90 patients who have undergone recent open heart surgery and are requiring an insulin infusion will be enrolled. They will be randomly assigned to one of three doses of detemir, which consists of 50%, 65%, or 80% of the total daily insulin infusion requirement in the fasting state. Subjects will also receive identical mealtime coverage according to the amount of carbohydrate (glucose) that is ingested. It is expected that the high dose group will achieve superior glycemic control without excessive hypoglycemia.

Study Design

• Study Type: Interventional
• Actual Enrollment: 82 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Transitioning Post-cardiothoracic Surgery Patients From Intravenous Insulin to the Subcutaneous Route With Insulin Detemir.
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Mar 1, 2010
• Actual Study Completion Date: Jun 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	Drug: Detemir; Detemir dosed at 50% of calculated basal insulin infusion requirements; Other Names: Levemir
Active Comparator: 2 Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	Drug: Detemir; Detemir dosed at 65% of calculated basal insulin infusion requirements
Active Comparator: 3 Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily	Drug: Detemir; Detemir dosed at 80% of calculated basal insulin infusion requirements

Outcome Measures

Primary Outcome Measures

1. Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3 [day 2, day 3]

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

Secondary Outcome Measures

1. Patients With Hypoglycemia (Defined as Glucose <65 mg/dl) [48 hours]

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

2. Reversion to Intravenous Insulin for Failure of Glycemic Control [72 hours]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• diabetes mellitus

• post-cardiothoracic surgery

• requiring an insulin infusion of at least 1 unit/hour

• Age 18-75

Exclusion Criteria:

• Glucocorticoids

• total parenteral nutrition (TPN) or tube feeds

• Pregnancy

• Surgical procedures in the next 48 hours for whom intravenous (IV) insulin will be expected

• Expected length of stay less than 48 hours following cessation of the insulin drip

• Patients using subcutaneous insulin pumps

• Diabetic ketoacidosis

• End-stage renal disease

• End-stage liver disease

• Coma

• Potentially sensitive admissions: prisoners, human immunodeficiency virus(HIV), suicidality

• Unable to give consent in English

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Ohio State University	Columbus	Ohio	United States	43210

Sponsors and Collaborators

• Ohio State University
• Novo Nordisk A/S

Investigators

• Principal Investigator: Kathleen M Dungan, MD, Ohio State University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kathleen Dungan, Assistant Professor of Medicine, Ohio State University
• ClinicalTrials.gov Identifier: NCT00717288
• Other Study ID Numbers: 2007H0210; 60016576
• First Posted: Jul 17, 2008
• Last Update Posted: Oct 3, 2011
• Last Verified: Aug 1, 2011

• Keywords provided by Kathleen Dungan, Assistant Professor of Medicine, Ohio State University: diabetes; hyperglycemia; open heart surgery; cardiothoracic surgery; detemir; insulin infusion; intravenous insulin
• Additional relevant MeSH terms: Insulin Detemir

Study Results

Participant Flow

Arm/Group Title	50% Conversion Factor	65% Conversion Factor	80% Conversion Factor
Arm/Group Description	Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Period Title: Overall Study
STARTED	28	29	25
COMPLETED	28	29	25
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	50% Conversion Factor	65% Conversion Factor	80% Conversion Factor	Total
Arm/Group Description	Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily	Total of all reporting groups
Overall Participants	28	29	25	82
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%	0 0%
Between 18 and 65 years	22 78.6%	24 82.8%	19 76%	65 79.3%
>=65 years	6 21.4%	5 17.2%	6 24%	17 20.7%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	58 (8.0)	57 (9.1)	61 (7.6)	58.7 (8.4)
Sex: Female, Male (Count of Participants)
Female	5 17.9%	4 13.8%	8 32%	17 20.7%
Male	23 82.1%	25 86.2%	17 68%	65 79.3%
Region of Enrollment (participants) [Number]
United States	28 100%	29 100%	25 100%	82 100%

Outcome Measures

1. Primary Outcome

Title	Patients With Morning (AM) Glucose Between 80-130 mg/dl on Day 2 and 3
Description	Number of patients with a morning glucose between 80-130 mg/dl on day 2 and day 3
Time Frame	day 2, day 3

Outcome Measure Data

Analysis Population Description

intention to treat (ITT)

Arm/Group Title	50% Conversion Factor	65% Conversion Factor	80% Conversion Factor
Arm/Group Description	Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily	Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily	Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
Measure Participants	28	29	25
Number [participants]	10 35.7%	18 62.1%	14 56%

2. Secondary Outcome

Title	Patients With Hypoglycemia (Defined as Glucose <65 mg/dl)
Description	Number of patients with hypoglycemia (defined as glucose <65 mg/dl)
Time Frame	48 hours

Outcome Measure Data

Analysis Population Description

Intention to treat (ITT)

Arm/Group Title	50% Conversion Factor	65% Conversion Factor	80% Conversion Factor
Arm/Group Description	Number of subjects with a BG value <65 mg/dl	Number of subjects with a BG value <65 mg/dl	Number of subjects with a BG value <65 mg/dl
Measure Participants	28	29	25
Number [participants]	0 0%	6 20.7%	3 12%

3. Secondary Outcome

Title	Reversion to Intravenous Insulin for Failure of Glycemic Control
Description	Number of participants who went back on intravenous insulin for failure of glycemic control.
Time Frame	72 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	50% Conversion Factor	65% Conversion Factor	80% Conversion Factor
Arm/Group Description	Number of subjects that reverted back to an insulin drip	Number of subjects that reverted back to an insulin drip	Number of subjects that reverted back to an insulin drip
Measure Participants	28	29	25
Number [participants]	2 7.1%	0 0%	1 4%

Adverse Events

Arm/Group Title	50% Conversion Factor		65% Conversion Factor		80% Conversion Factor
Arm/Group Description	Detemir insulin dosed at 50% of calculated basal insulin infusion requirement injected once daily		Detemir insulin dosed at 65% of calculated basal insulin infusion requirement injected once daily		Detemir insulin dosed at 80% of calculated basal insulin infusion requirement injected once daily
All Cause Mortality
	50% Conversion Factor		65% Conversion Factor		80% Conversion Factor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	50% Conversion Factor		65% Conversion Factor		80% Conversion Factor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/29 (0%)		1/25 (4%)
General disorders
Death	0/28 (0%)	0	0/28 (0%)	0	1/25 (4%)	1
Other (Not Including Serious) Adverse Events
	50% Conversion Factor		65% Conversion Factor		80% Conversion Factor
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/28 (0%)		0/29 (0%)		1/25 (4%)
Endocrine disorders
BG <40 mg/dl	0/28 (0%)	0	0/29 (0%)	0	1/25 (4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.