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

University of Florida

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Drug: Apidra; Drug: Novolog; Drug: Humalog

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01621776

3842011

Details and patient eligibility

About

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

Full 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.

Enrollment: 107 patients

Sex: All

Ages: 9 to 14 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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107 participants in 3 patient groups

Humalog

Active Comparator 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.

Treatment:

Drug: Humalog

Apidra

Active Comparator group

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.

Treatment:

Drug: Apidra

Novolog

Active Comparator group

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.)

Treatment:

Drug: Novolog