Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus

October 6, 2014 updated by: Medical University of Warsaw

The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.

The aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).

Study Type

Interventional

Enrollment (Actual)

64

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Warsaw, Poland, 01-184
        • Department of Pediatrics, Medical University of Warsaw, Poland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 diabetes mellitus
  • CSII for at least 3 months
  • Duration of diabetes > 1 years
  • Informed consent

Exclusion Criteria:

  • Concomitant dietary restrictions (e.g. celiac disease or food allergy)
  • Diabetes related complications
  • Baseline hyperglycemia >150 mg/dl
  • Any disease judged by the investigator to affect the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: GLU_ASP

Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.

First day: insulin glulisine

Second day: insulin aspart
Drug: Insulin aspart
Other Names:
  • NovoRapid®
Drug: Insulin glulisine
Other Names:
  • Apidra®
EXPERIMENTAL: ASP_GLU

Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.

First day: insulin aspart

Second day: insulin glulisine
Drug: Insulin aspart
Other Names:
  • NovoRapid®
Drug: Insulin glulisine
Other Names:
  • Apidra®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postprandial glycemia
Time Frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast
baseline, 30, 60, 90, 120 and 180 minutes after the breakfast

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hypoglycemia episodes
Time Frame: 3-h study period
Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms
3-h study period
Glucose Area Under the Curve (AUC)
Time Frame: 3-h study period
based on continuous glucose monitoring system
3-h study period
Mean amplitude of glycemic excursion (MAGE)
Time Frame: 3-h study period
3-h study period
Difference between the maximum and baseline glycemia
Time Frame: 3-h study period
3-h study period

Other Outcome Measures

Outcome Measure
Time Frame
Questionnaire: Glycemic Index Knowledge
Time Frame: each subject was asked to fullfill the questionnaire before entering the study (day one)
each subject was asked to fullfill the questionnaire before entering the study (day one)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Warsaw

Investigators

  • Principal Investigator: Katarzyna Dżygało, MD, Department of Pediatrics, Medical University of Warsaw, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (ACTUAL)

September 1, 2012

Study Completion (ACTUAL)

September 1, 2012

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

August 31, 2012

First Posted (ESTIMATE)

September 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

October 7, 2014

Last Update Submitted That Met QC Criteria

October 6, 2014

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Glulisine_Aspart

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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