Trial Outcomes & Findings for Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes (NCT NCT00590226)

Results Overview

average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

130 participants

Primary outcome timeframe

during hospitalization

Results posted on

2014-06-11

Participant Flow

This study was conducted at Grady Memorial Hospital in Atlanta, GA and at Rush University Medical Center, Chicago, IL. IRB approval was given at each center and consent was obtained from all subjects. Patients with a h/o T2DM were recruited in 2007.

Participant milestones

Participant milestones
Measure	Detemir + Aspart Detemir insulin once daily + aspart insulin before meals	NPH+Regular NPH insulin + regular insulin before breakfast and dinner
Overall Study STARTED	67	63
Overall Study COMPLETED	67	63
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Insulin Detemir Versus NPH Insulin In Hospitalized Patients With Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Detemir + Aspart n=67 Participants Detemir insulin once daily + aspart insulin before meals	NPH+Regular n=63 Participants NPH insulin + regular insulin before breakfast and dinner	Total n=130 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
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	57 Participants n=7 Participants	117 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Age, Continuous	59 years STANDARD_DEVIATION 10 • n=5 Participants	58 years STANDARD_DEVIATION 10 • n=7 Participants	58 years STANDARD_DEVIATION 10 • n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	33 Participants n=7 Participants	70 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment United States	67 participants n=5 Participants	63 participants n=7 Participants	130 participants n=5 Participants

PRIMARY outcome

Timeframe: during hospitalization

average AM daily BG with detemir insulin once daily plus insulin aspart before meals and NPH insulin twice daily plus regular insulin before meals in patients with DM2

Outcome measures

Outcome measures
Measure	Detemir + Aspart n=67 Participants Detemir insulin once daily + aspart insulin before meals	NPH+Regular n=63 Participants NPH insulin + regular insulin before breakfast and dinner
Mean AM BG (mg/dl)	144 mg/dl Standard Deviation 56	155 mg/dl Standard Deviation 62

SECONDARY outcome

Timeframe: during hospitalization

number of patients with hypoglycemic events as defined as BG 40-59 mg/dl

Outcome measures

Outcome measures
Measure	Detemir + Aspart n=67 Participants Detemir insulin once daily + aspart insulin before meals	NPH+Regular n=63 Participants NPH insulin + regular insulin before breakfast and dinner
Number of Patients With Hypoglycemic Events	15 participants	13 participants

Adverse Events

Detemir + Aspart

Serious events: 15 serious events

Other events: 0 other events

Deaths: 0 deaths

NPH+Regular

Serious events: 13 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Detemir + Aspart n=67 participants at risk Detemir insulin once daily + aspart insulin before meals	NPH+Regular n=63 participants at risk NPH insulin + regular insulin before breakfast and dinner
Metabolism and nutrition disorders Hypoglycemia	22.4% 15/67 • Number of events 15 • during study period in the hospital Hypoglycemic event is defined as blood glucose \< 60 mg/dl. All serious adverse events were monitored.	20.6% 13/63 • Number of events 13 • during study period in the hospital Hypoglycemic event is defined as blood glucose \< 60 mg/dl. All serious adverse events were monitored.

Other adverse events

Adverse event data not reported

Additional Information

Guillermo Umpierrez, MD

EUSOM

Phone: 4047781665

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place