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Completed

NCT Number: NCT01621776

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

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

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

9 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Camp Winona

DeLeon Springs, Florida, 32130, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Apidra

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.

Other names: Insulin glulisine

Humalog

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.

Other names: Insulin lispro

NovoLog

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.)

Other names: Insulin aspart

Primary outcomes

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

    Time frame: 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 outcomes

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

    Time frame: 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

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 18, 2012
Registry last updated
Sep 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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