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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Florida
ClinicalTrials.gov Identifier:
NCT01621776
First received: June 11, 2012
Last updated: September 12, 2013
Last verified: January 2013
  Purpose

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


Condition Intervention
Type 1 Diabetes
Drug: Apidra
Drug: Humalog
Drug: Novolog

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Comparison of Effectiveness of Glulisine and Lispro in Decreasing Post-Prandial Hyperglycemia in a Real-World Setting

Resource links provided by NLM:


Further study details as provided by University of Florida:

Primary Outcome Measures:
  • The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. [ Time Frame: averaged over 5 days ] [ Designated as safety issue: No ]

    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 [ Time Frame: averaged over 5 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: averaged over 5 days ] [ Designated as safety issue: No ]
    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.


Enrollment: 107
Study Start Date: June 2011
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
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.
Other Name: Insulin lispro
Active Comparator: 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.
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.
Other Name: Insulin glulisine
Active Comparator: 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.)
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.)
Other Name: Insulin aspart

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.

  Eligibility

Ages Eligible for Study:   9 Years to 14 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01621776

Locations
United States, Florida
Camp Winona
DeLeon Springs, Florida, United States, 32130
Sponsors and Collaborators
University of Florida
Sanofi
Investigators
Principal Investigator: Janet Silverstein, M.D. University of Florida
  More Information

No publications provided

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT01621776     History of Changes
Other Study ID Numbers: 3842011
Study First Received: June 11, 2012
Results First Received: June 21, 2013
Last Updated: September 12, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Florida:
post-prandial hyperglycemia

Additional relevant MeSH terms:
Diabetes Mellitus, Type 1
Hyperglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin glulisine
Insulin
Insulin Aspart
Insulin Lispro
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014