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

NCT01621776 | Completed Results

• 1 other identifier: 3842011
• Study Type: interventional
• Target: 107
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type 1 Diabetes

Keywords

post-prandial hyperglycemia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (2)

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

  averaged over 5 days

• Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast

  averaged over 5 days

Study Arms (3)

Humalog

ACTIVE COMPARATOR

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

Apidra

ACTIVE COMPARATOR

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

Novolog

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Insulin glulisine

Apidra

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.

Also known as: Insulin lispro

Humalog

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.)

Also known as: Insulin aspart

Novolog

Eligibility Criteria

• Age: 9 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Diagnosis of type 1 Diabetes
• Children and Youth attending Florida Diabetes Camp in DeLand, FL

You may not qualify if:

• only campers participating in sessions I and II are eligible to participate

Sponsors & Collaborators

• University of Florida: lead
• Sanofi: collaborator

Study Sites (1)

Camp Winona

DeLeon Springs, Florida, 32130, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

insulin glulisine; Insulin Lispro; Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and Caveats

In the first year (Camp 2011) there were 2 arms, the Humalog and Apidra. In the second year (Camp 2012) there were 3 arms, the Humalog, Apidra, and Novolog. Therefore, there will be more participants in the Humalog and Apidra arms.

Results Point of Contact

• Title: Janet Silverstein, MD
• Organization: University of Florida

silvejh@peds.ufl.edu

352-334-1390

Study Officials

• Janet Silverstein, M.D.

  University of Florida

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2012
• First Posted: June 18, 2012
• Study Start: June 1, 2011
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: September 13, 2013
• Results First Posted: September 13, 2013

Record last verified: 2013-01

Locations

US (1)