Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy

• Sponsor: University of Colorado, Denver (Other)
• Overall Status: Completed
• CT.gov ID: NCT01186003
• Collaborator: Novo Nordisk A/S (Industry)
• Enrollment: 30
• Location: 1
• Arms: 2
• Actual Duration (Months): 45
• Patients Per Site Per Month: 0.7

Study Details

Study Description

Brief Summary

The investigators anticipate that the use of Detemir will decrease the duration of an insulin drip, the dose of short-acting insulin in the drip, hospital and ICU (intensive care unit) length of stay, improve glycemic control, and prevent rebound hyperglycemias when the insulin drip is discontinued.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Drug: Detemir	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 30 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effectiveness of a Subcutaneously Administered Long-Acting Insulin Detemir Added to Insulin Drip Therapy as Compared With Standard Insulin Drip Treatment
• Actual Study Start Date: Aug 1, 2010
• Actual Primary Completion Date: May 1, 2014
• Actual Study Completion Date: May 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Standard insulin drip therapy
Active Comparator: Insulin drip and Detemir Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy	Drug: Detemir; Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy; Other Names: Levimir

Outcome Measures

Primary Outcome Measures

1. Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl) [within 48 hours of discontinuation]

   Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl)

Secondary Outcome Measures

1. Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose [within one week of insulin drip therapy]

2. Reduction in ICU Length of Stay [within two weeks of hospitalization]

3. Equal or Improved Diabetes Control [within two weeks of hospitalization]

4. Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs [within one week post insulin drip]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 19 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diabetic ketoacidosis (DKA) and hyperosmolar non-ketotic states, hyperglycemia with severe illness, pre-and postoperative states, nothing by mouth (NPO), as well as gastric (tube feeding) and parenteral nutritional requiring insulin drip.

• Patients with type 1 and type 2 diabetes mellitus (DM) will be included.

• Patient with both types of diabetes will be among those treated with insulin drip while being NPO, having severe concomitant illness or receiving enteral and parenteral nutrition

• Patients will be of age 19 to 80.

Exclusion Criteria:

• Inability to consent for the study for any reason including cognitive impairment secondary to hyperglycemia, presence of severe medical conditions requiring intubation, severe sepsis, hypothermia, and anticipated length of insulin drop 2 weeks and longer, pregnancy, Levemir allergy, and concurrent sulfonamide treatment

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado Denver	Aurora	Colorado	United States	80045

Sponsors and Collaborators

• University of Colorado, Denver
• Novo Nordisk A/S

Investigators

• Principal Investigator: Boris Draznin, MD., Ph.D., University of Colorado, Denver

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Colorado, Denver
• ClinicalTrials.gov Identifier: NCT01186003
• Other Study ID Numbers: 10-0483
• First Posted: Aug 20, 2010
• Last Update Posted: Dec 7, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Colorado, Denver: Diabetes
• Additional relevant MeSH terms: Insulin Detemir

Study Results

Participant Flow

Arm/Group Title	Standard Insulin Drip Therapy	Insulin Drip and Detemir
Arm/Group Description	Continuous IV insulin infusion without added detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Period Title: Overall Study
STARTED	14	16
COMPLETED	14	16
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Standard Insulin Drip Therapy	Insulin Drip and Detemir	Total
Arm/Group Description	Continuous IV insulin infusion without added detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy	Total of all reporting groups
Overall Participants	14	16	30
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	52.3 (11.2)	54.1 (16.2)	53.26 (14.36)
Sex: Female, Male (Count of Participants)
Female	3 21.4%	4 25%	7 23.3%
Male	11 78.6%	12 75%	23 76.7%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 14.3%	3 18.8%	5 16.7%
Not Hispanic or Latino	12 85.7%	13 81.3%	25 83.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 6.3%	1 3.3%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	3 21.4%	2 12.5%	5 16.7%
White	11 78.6%	13 81.3%	24 80%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%	16 100%	30 100%

Outcome Measures

1. Primary Outcome

Title	Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)
Description	Number of participants exhibiting rebound hyperglycemia (blood glucose levels over 180 mg/dl)
Time Frame	within 48 hours of discontinuation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Standard Insulin Drip Therapy	Insulin Drip and Detemir
Arm/Group Description	Continuous IV insulin infusion without added detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Measure Participants	14	16
Count of Participants [Participants]	14 100%	3 18.8%

2. Secondary Outcome

Title	Reduction in Duration of Insulin Drip Therapy and Reduction in Total and Average Per Hour Insulin Drip Dose
Time Frame	within one week of insulin drip therapy

Outcome Measure Data

Analysis Population Description

We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.

Arm/Group Title	Standard Insulin Drip Therapy	Insulin Drip and Detemir
Arm/Group Description	Continuous IV insulin infusion without added detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Measure Participants	0	0

3. Secondary Outcome

Title	Reduction in ICU Length of Stay
Time Frame	within two weeks of hospitalization

Outcome Measure Data

Analysis Population Description

We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.

Arm/Group Title	Standard Insulin Drip Therapy	Insulin Drip and Detemir
Arm/Group Description	Continuous IV insulin infusion without added detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Measure Participants	0	0

4. Secondary Outcome

Title	Equal or Improved Diabetes Control
Time Frame	within two weeks of hospitalization

Outcome Measure Data

Analysis Population Description

We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.

Arm/Group Title	Standard Insulin Drip Therapy	Insulin Drip and Detemir
Arm/Group Description	Continuous IV insulin infusion without added detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Measure Participants	0	0

5. Secondary Outcome

Title	Reduction in Time to Get Back to Control of Glycemia (140-180 mg/dl) if Rebound Hyperglycemia Occurs
Time Frame	within one week post insulin drip

Outcome Measure Data

Analysis Population Description

We have no information regarding whether this outcome measure was collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, this outcome measure cannot be reported.

Arm/Group Title	Standard Insulin Drip Therapy	Insulin Drip and Detemir
Arm/Group Description	Continuous IV insulin infusion without added detemir	Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Measure Participants	0	0

Adverse Events

Time Frame	1 Week
Arm/Group Title	Standard Insulin Drip Therapy		Insulin Drip and Detemir
Arm/Group Description	Continuous IV insulin infusion without added detemir		Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
All Cause Mortality
	Standard Insulin Drip Therapy		Insulin Drip and Detemir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/16 (0%)
Serious Adverse Events
	Standard Insulin Drip Therapy		Insulin Drip and Detemir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/16 (0%)
Other (Not Including Serious) Adverse Events
	Standard Insulin Drip Therapy		Insulin Drip and Detemir
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/16 (0%)

Limitations/Caveats

We have no information regarding whether many of the outcome measure were collected or analyzed. The PI has retired, and CU Clinical Research Administration has contacted the study team and PI on numerous occasions to try and obtain the data, but have not been able to do so. Therefore, several outcome measures cannot be reported.

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.