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

Primary Purpose

Type 1 Diabetes

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apidra
Humalog
Novolog
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 1 Diabetes focused on measuring post-prandial hyperglycemia

Eligibility Criteria

9 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Camp Winona

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Humalog

Apidra

Novolog

Arm 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.)

Outcomes

Primary Outcome Measures

The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at 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.

Secondary Outcome Measures

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

Full Information

First Posted
June 11, 2012
Last Updated
September 12, 2013
Sponsor
University of Florida
Collaborators
Sanofi
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1. Study Identification

Unique Protocol Identification Number
NCT01621776
Brief Title
Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia
Official Title
Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting
Study Type
Interventional

2. Study Status

Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2011 (undefined)
Primary Completion Date
August 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
Sanofi

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
post-prandial hyperglycemia

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
107 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Humalog
Arm Type
Active Comparator
Arm 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.
Arm Title
Apidra
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Novolog
Arm Type
Active Comparator
Arm Description
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.)
Intervention Type
Drug
Intervention Name(s)
Apidra
Other Intervention Name(s)
Insulin glulisine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Humalog
Other Intervention Name(s)
Insulin lispro
Intervention 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.
Intervention Type
Drug
Intervention Name(s)
Novolog
Other Intervention Name(s)
Insulin aspart
Intervention Description
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.)
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janet Silverstein, M.D.
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Camp Winona
City
DeLeon Springs
State/Province
Florida
ZIP/Postal Code
32130
Country
United States

12. IPD Sharing Statement

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

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