Trial Outcomes & Findings for Prandial Insulin Dosing in Hospitalized Patients (NCT NCT01101867)

Results Overview

Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

126 participants

Primary outcome timeframe

day 3

Results posted on

2018-01-31

Participant Flow

Participant milestones

Participant milestones
Measure	Flexible Dose Insulin Aspart dose is determined based upon carbohydrate intake and is administered immediately post-meal. Prandial insulin was based upon the formula: CIR=400/TDD where CIR refers to the carbohydrate-to-insulin ratio and TDD refers to the total daily calculated dose of insulin (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively).	Fixed Dose Fixed meal dose of Insulin Aspart (based upon total daily insulin dose or upon weight, depending upon whether a patient is insulin naive or not, respectively). Half of the TDD was divided into three equal fixed doses given immediately after each meal.
Overall Study STARTED	63	63
Overall Study COMPLETED	62	59
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Prandial Insulin Dosing in Hospitalized Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Flexible Dose n=63 Participants aspart dose determined based upon carbohydrate intake.	Fixed Dose n=63 Participants fixed meal dose of aspart (based upon weight or total daily insulin dose)	Total n=126 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	48 Participants n=5 Participants	49 Participants n=7 Participants	97 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants	14 Participants n=7 Participants	29 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 10 • n=5 Participants	56 years STANDARD_DEVIATION 12 • n=7 Participants	57 years STANDARD_DEVIATION 11 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	29 Participants n=7 Participants	54 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants	34 Participants n=7 Participants	72 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants	63 participants n=7 Participants	126 participants n=5 Participants

PRIMARY outcome

Timeframe: day 3

Population: Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.

Mean glucose was calculated per participant from the average of glucose values over the 7-point (pre- and post-breakfast, lunch, dinner, and bed) glucose profile at day 3

Outcome measures

Outcome measures
Measure	Flexible Dose n=42 Participants aspart dose determined based upon carbohydrate intake.	Fixed Dose n=37 Participants fixed meal dose of aspart (based upon weight or total daily insulin dose)
Mean Glucose	158 mg/dl Standard Deviation 47	171 mg/dl Standard Deviation 49

SECONDARY outcome

Timeframe: day 3

Population: Data were only available in 79 subjects on day 3 due to hospital discharge or NPO status.

Mean postprandial glucose was calculated per participant from the average of glucose values (post-breakfast, lunch, dinner) at day 3.

Outcome measures

Outcome measures
Measure	Flexible Dose n=42 Participants aspart dose determined based upon carbohydrate intake.	Fixed Dose n=37 Participants fixed meal dose of aspart (based upon weight or total daily insulin dose)
Postprandial Glucose	175 mg/dl Standard Deviation 51	203 mg/dl Standard Deviation 74

SECONDARY outcome

Timeframe: 72 hour

Number of patients with any hypoglycemic event (\<70 mg/dl or \<40 mg/dl)

Outcome measures

Outcome measures
Measure	Flexible Dose n=62 Participants aspart dose determined based upon carbohydrate intake.	Fixed Dose n=59 Participants fixed meal dose of aspart (based upon weight or total daily insulin dose)
Hypoglycemia	24 participants	14 participants

SECONDARY outcome

Timeframe: 72 hour

Population: intention to treat population

Change in mean glucose from day 1 to day 3, measured as difference in mean glucose day 3 minus mean glucose day 1.

Outcome measures

Outcome measures
Measure	Flexible Dose n=42 Participants aspart dose determined based upon carbohydrate intake.	Fixed Dose n=37 Participants fixed meal dose of aspart (based upon weight or total daily insulin dose)
Change in Glucose	-4.2 mg/dl Standard Deviation 35	-8.1 mg/dl Standard Deviation 54

SECONDARY outcome

Timeframe: day 3

Population: all participants who completed the survey

treatment satisfaction questionnaire validated in-hospital, 19 item questionnaire using 0-6 point likert scale, for minimum zero to maximum of 102 points (with 102 indicating best satisfaction). Items are summed to find the total score.

Outcome measures

Outcome measures
Measure	Flexible Dose n=50 Participants aspart dose determined based upon carbohydrate intake.	Fixed Dose n=50 Participants fixed meal dose of aspart (based upon weight or total daily insulin dose)
Treatment Satisfaction	69 points on a scale Standard Deviation 14	68 points on a scale Standard Deviation 13

SECONDARY outcome

Timeframe: day 1 to day 3

Population: subjects with complete data

change in short-term measure of glycemia

Outcome measures

Outcome measures
Measure	Flexible Dose n=41 Participants aspart dose determined based upon carbohydrate intake.	Fixed Dose n=32 Participants fixed meal dose of aspart (based upon weight or total daily insulin dose)
1,5-anhydroglucitol Change	0.41 mcg/ml Standard Deviation 2.76	0.73 mcg/ml Standard Deviation 3.96

Adverse Events

Flexible Dose

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

Fixed Dose

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Flexible Dose n=62 participants at risk aspart dose determined based upon carbohydrate intake.	Fixed Dose n=59 participants at risk fixed meal dose of aspart (based upon weight or total daily insulin dose)
Endocrine disorders Hypoglycemia (BG <70 mg/dl)	38.7% 24/62 • 72 hours	23.7% 14/59 • 72 hours

Additional Information

Dr. Kathleen Dungan

The Ohio State University

Phone: 614-685-3333

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place