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

NCT ID: NCT01621776

Last Updated: 2013-09-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

107 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2012-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Type 1 Diabetes

Keywords

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post-prandial hyperglycemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Humalog

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Apidra

Intervention Type DRUG

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.)

Group Type ACTIVE_COMPARATOR

Novolog

Intervention Type DRUG

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.)

Interventions

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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.

Intervention Type 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.

Intervention Type 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.)

Intervention Type DRUG

Other Intervention Names

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Insulin glulisine Insulin lispro Insulin aspart

Eligibility Criteria

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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
Minimum Eligible Age

9 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sanofi

INDUSTRY

Sponsor Role collaborator

University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Janet Silverstein, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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Camp Winona

DeLeon Springs, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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3842011

Identifier Type: -

Identifier Source: org_study_id