Trial Outcomes & Findings for Effectiveness of Adding Subcutaneous Long-Acting Detemir to Insulin Drip Therapy Compared With Standard Insulin Drip Therapy (NCT NCT01186003)

NCT ID: NCT01186003

Last Updated: 2021-12-07

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

30 participants

Primary outcome timeframe

within 48 hours of discontinuation

Results posted on

2021-12-07

Participant Flow

Participant milestones

Participant milestones
Measure	Standard Insulin Drip Therapy Continuous IV insulin infusion without added detemir	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
Overall Study STARTED	14	16
Overall Study COMPLETED	14	16
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Standard Insulin Drip Therapy n=14 Participants Continuous IV insulin infusion without added detemir	Insulin Drip and Detemir n=16 Participants Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy	Total n=30 Participants Total of all reporting groups
Age, Continuous	52.3 years STANDARD_DEVIATION 11.2 • n=5 Participants	54.1 years STANDARD_DEVIATION 16.2 • n=7 Participants	53.26 years STANDARD_DEVIATION 14.36 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	12 Participants n=5 Participants	13 Participants n=7 Participants	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	11 Participants n=5 Participants	13 Participants n=7 Participants	24 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	14 participants n=5 Participants	16 participants n=7 Participants	30 participants n=5 Participants

PRIMARY outcome

Timeframe: within 48 hours of discontinuation

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

Outcome measures

Outcome measures
Measure	Standard Insulin Drip Therapy n=14 Participants Continuous IV insulin infusion without added detemir	Insulin Drip and Detemir n=16 Participants Detemir 0.25 units per kg body weight given subcutaneously every 24 hours while patients are receiving intravenous (IV) standard insulin drip therapy
Reduction in Rebound Hyperglycemia (Blood Glucose Levels Over 180 mg/dl)	14 Participants	3 Participants

SECONDARY outcome

Timeframe: within one week of insulin drip therapy

Population: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two weeks of hospitalization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within two weeks of hospitalization

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: within one week post insulin drip

Outcome measures

Outcome data not reported

Adverse Events

Standard Insulin Drip Therapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Insulin Drip and Detemir

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director, Clinical Research Administration

University of Colorado Denver

Phone: 3037241111

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place