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

• Sponsor: University of Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01621776
• Collaborator: Sanofi (Industry)
• Enrollment: 107
• Location: 1
• Arms: 3
• Duration (Months): 14
• Patients Per Site Per Month: 7.6

Study Details

Study Description

Brief Summary

This study aims to compare the post-meal blood glucose values of two drugs in a "real-world" setting.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes	Drug: Apidra; Drug: Humalog; Drug: Novolog	N/A

Detailed Description

This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.

Study Design

• Study Type: Interventional
• Actual Enrollment: 107 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Aug 1, 2012
• Actual Study Completion Date: Aug 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: 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.; Other Names: Insulin lispro
Active Comparator: 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.	Drug: 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.; Other Names: Insulin glulisine
Active Comparator: 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.)	Drug: 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.); Other Names: Insulin aspart

Outcome Measures

Primary Outcome Measures

1. The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. [averaged over 5 days]

   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.

Secondary Outcome Measures

1. Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner [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.

2. Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years to 14 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Diagnosis of type 1 Diabetes

• Children and Youth attending Florida Diabetes Camp in DeLand, FL

Exclusion Criteria:

• only campers participating in sessions I and II are eligible to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Camp Winona	DeLeon Springs	Florida	United States	32130

Sponsors and Collaborators

• University of Florida
• Sanofi

Investigators

• Principal Investigator: Janet Silverstein, M.D., University of Florida

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Florida
• ClinicalTrials.gov Identifier: NCT01621776
• Other Study ID Numbers: 3842011
• First Posted: Jun 18, 2012
• Last Update Posted: Sep 13, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by University of Florida: post-prandial hyperglycemia
• Additional relevant MeSH terms: Hyperglycemia; Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine

Study Results

Participant Flow

Recruitment Details	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.
Pre-assignment Detail	There were 107 participants consented to the study. 8 participants were withdrawn prior to randomization to the study.

Arm/Group Title	Humalog	Apidra	Novolog
Arm/Group Description	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.	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.	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.)
Period Title: Overall Study
STARTED	41	40	18
COMPLETED	41	40	18
NOT COMPLETED	0	0	0

Baseline Characteristics

Arm/Group Title	Humalog	Apidra	Novolog	Total
Arm/Group Description	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.	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.	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 of all reporting groups
Overall Participants	41	40	18	99
Age (Count of Participants)
<=18 years	41 100%	40 100%	18 100%	99 100%
Between 18 and 65 years	0 0%	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	21 51.2%	21 52.5%	11 61.1%	53 53.5%
Male	20 48.8%	19 47.5%	7 38.9%	46 46.5%
Region of Enrollment (participants) [Number]
United States	41 100%	40 100%	18 100%	99 100%

Outcome Measures

1. Primary Outcome

Title	The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.
Description	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.
Time Frame	averaged over 5 days

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Humalog	Apidra	Novolog
Arm/Group Description	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.	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.	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.)
Measure Participants	41	40	18
Mean (Standard Deviation) [mg/dl]	146.69 (79.19)	143.68 (79.48)	149.02 (71.56)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Humalog, Apidra, Novolog
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.971
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	145.10
	Confidence Interval	() 95%; 129.73 to 160.47
	Parameter Dispersion	Type: Standard Deviation; Value: 78.04
	Estimation Comments	This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.

2. Secondary Outcome

Title	Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner
Description	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.
Time Frame	averaged over 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Humalog	Apidra	Novolog
Arm/Group Description	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.	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.	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.)
Measure Participants	41	40	18
Mean (Standard Deviation) [mg/dl]	170.57 (50.54)	160.96 (73.54)	153.46 (62.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Humalog, Apidra, Novolog
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.698
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	161.09
	Confidence Interval	(2-Sided) 95%; 144.91 to 177.28
	Parameter Dispersion	Type: Standard Deviation; Value: 62.67
	Estimation Comments	This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.

3. Secondary Outcome

Title	Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast
Description	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.
Time Frame	averaged over 5 days

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Humalog	Apidra	Novolog
Arm/Group Description	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.	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.	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.)
Measure Participants	41	40	18
Mean (Standard Deviation) [mg/dl]	225.62 (111.48)	225.46 (81.14)	208.64 (76.53)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Humalog, Apidra, Novolog
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	.806
	Comments
	Method	ANOVA
	Comments
Method of Estimation	Estimation Parameter	Mean Difference (Final Values)
	Estimated Value	220.46
	Confidence Interval	(2-Sided) 95%; 197.22 to 243.71
	Parameter Dispersion	Type: Standard Deviation; Value: 89.97
	Estimation Comments	This is a three arm study that is not seeking to engage in comparison between individual arms, therefore the mean difference across the study arms is reported.

Adverse Events

Time Frame	July 2011 through July 2012
Arm/Group Title	Humalog		Apidra		Novolog
Arm/Group Description	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.		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.		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.)
All Cause Mortality
	Humalog		Apidra		Novolog
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Humalog		Apidra		Novolog
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/41 (0%)		0/40 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Humalog		Apidra		Novolog
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	41/41 (100%)		40/40 (100%)		18/18 (100%)
Endocrine disorders
Hypoglycemic Event	41/41 (100%)	105	40/40 (100%)	124	18/18 (100%)	35

Limitations/Caveats

In the first year (Camp 2011) there were 2 arms, the Humalog and Apidra. In the second year (Camp 2012) there were 3 arms, the Humalog, Apidra, and Novolog. Therefore, there will be more participants in the Humalog and Apidra arms.

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.