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

Type 1 Diabetes Clinical Trial

Official title:

Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01621776
• Other study ID #: 3842011
• Status: Completed
• Phase: N/A
• First received: June 11, 2012
• Last updated: September 12, 2013
• Start date: June 2011
• Est. completion date: August 2012

Study information

• Verified date: January 2013
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 9 Years to 14 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Hyperglycemia
• Type 1 Diabetes

Intervention

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.
• 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.
• 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.)

Locations

Country	Name	City	State
United States	Camp Winona	DeLeon Springs	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	averaged over 5 days	No
Secondary	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.	averaged over 5 days	No
Secondary	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.	averaged over 5 days	No