Trial Outcomes & Findings for Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia (NCT NCT01621776)

Results Overview

Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

107 participants

Primary outcome timeframe

averaged over 5 days

Results posted on

2013-09-13

Participant Flow

The study was conducted at the Florida Camp for Children \& Youth with Diabetes during the summers of 2011 and 2012. In the summer of 2012 an additional arm was added to the study to include Novolog.

There were 107 participants consented to the study. 8 participants were withdrawn prior to randomization to the study.

Participant milestones

Participant milestones
Measure	Humalog Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Apidra Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Novolog Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
Overall Study STARTED	41	40	18
Overall Study COMPLETED	41	40	18
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Humalog n=41 Participants Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Apidra n=40 Participants Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Novolog n=18 Participants Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)	Total n=99 Participants Total of all reporting groups
Age, Categorical <=18 years	41 Participants n=5 Participants	40 Participants n=7 Participants	18 Participants n=5 Participants	99 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Sex: Female, Male Female	21 Participants n=5 Participants	21 Participants n=7 Participants	11 Participants n=5 Participants	53 Participants n=4 Participants
Sex: Female, Male Male	20 Participants n=5 Participants	19 Participants n=7 Participants	7 Participants n=5 Participants	46 Participants n=4 Participants
Region of Enrollment United States	41 participants n=5 Participants	40 participants n=7 Participants	18 participants n=5 Participants	99 participants n=4 Participants

PRIMARY outcome

Timeframe: averaged over 5 days

Population: Post-Prandial Blood Glucose Values \[Within 90 minutes following the completion of participant lunch\]

Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona.

Outcome measures

Outcome measures
Measure	Humalog n=41 Participants Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Apidra n=40 Participants Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Novolog n=18 Participants Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.	146.69 mg/dl Standard Deviation 79.19	143.68 mg/dl Standard Deviation 79.48	149.02 mg/dl Standard Deviation 71.56

SECONDARY outcome

Timeframe: averaged over 5 days

Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.

Outcome measures

Outcome measures
Measure	Humalog n=41 Participants Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Apidra n=40 Participants Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Novolog n=18 Participants Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner	170.57 mg/dl Standard Deviation 50.54	160.96 mg/dl Standard Deviation 73.54	153.46 mg/dl Standard Deviation 62.72

SECONDARY outcome

Timeframe: averaged over 5 days

Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.

Outcome measures

Outcome measures
Measure	Humalog n=41 Participants Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Apidra n=40 Participants Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Novolog n=18 Participants Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast	225.62 mg/dl Standard Deviation 111.48	225.46 mg/dl Standard Deviation 81.14	208.64 mg/dl Standard Deviation 76.53

Adverse Events

Humalog

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

Apidra

Serious events: 0 serious events

Other events: 40 other events

Deaths: 0 deaths

Novolog

Serious events: 0 serious events

Other events: 18 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Humalog n=41 participants at risk Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Apidra n=40 participants at risk Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.	Novolog n=18 participants at risk Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
Endocrine disorders Hypoglycemic Event	100.0% 41/41 • Number of events 105 • July 2011 through July 2012	100.0% 40/40 • Number of events 124 • July 2011 through July 2012	100.0% 18/18 • Number of events 35 • July 2011 through July 2012

Additional Information

Janet Silverstein, MD

University of Florida

Phone: 352-334-1390

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place