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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
Insulin glulisine
Insulin aspart
Sponsored by
Medical University of Warsaw
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring diabetes, insulin pump, glulisine, aspart, glycemic index

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Pediatrics, Medical University of Warsaw, Poland

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GLU_ASP

ASP_GLU

Arm Description

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

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

Outcomes

Primary Outcome Measures

Postprandial glycemia

Secondary Outcome Measures

Hypoglycemia episodes
Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms
Glucose Area Under the Curve (AUC)
based on continuous glucose monitoring system
Mean amplitude of glycemic excursion (MAGE)
Difference between the maximum and baseline glycemia

Full Information

First Posted
August 28, 2012
Last Updated
October 6, 2014
Sponsor
Medical University of Warsaw
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1. Study Identification

Unique Protocol Identification Number
NCT01678235
Brief Title
Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical University of Warsaw

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
diabetes, insulin pump, glulisine, aspart, glycemic index

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GLU_ASP
Arm Type
Experimental
Arm Description
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
Arm Title
ASP_GLU
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Insulin glulisine
Other Intervention Name(s)
Apidra®
Intervention Type
Drug
Intervention Name(s)
Insulin aspart
Other Intervention Name(s)
NovoRapid®
Primary Outcome Measure Information:
Title
Postprandial glycemia
Time Frame
baseline, 30, 60, 90, 120 and 180 minutes after the breakfast
Secondary Outcome Measure Information:
Title
Hypoglycemia episodes
Description
Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms
Time Frame
3-h study period
Title
Glucose Area Under the Curve (AUC)
Description
based on continuous glucose monitoring system
Time Frame
3-h study period
Title
Mean amplitude of glycemic excursion (MAGE)
Time Frame
3-h study period
Title
Difference between the maximum and baseline glycemia
Time Frame
3-h study period
Other Pre-specified Outcome Measures:
Title
Questionnaire: Glycemic Index Knowledge
Time Frame
each subject was asked to fullfill the questionnaire before entering the study (day one)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katarzyna Dżygało, MD
Organizational Affiliation
Department of Pediatrics, Medical University of Warsaw, Poland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Pediatrics, Medical University of Warsaw, Poland
City
Warsaw
ZIP/Postal Code
01-184
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
24412929
Citation
Dzygalo K, Szypowska A. Impact of insulins glulisine and aspart on postprandial glycemia after a high-glycemic index meal in children with type 1 diabetes. Eur J Endocrinol. 2014 Mar 8;170(4):539-45. doi: 10.1530/EJE-13-0696. Print 2014 Apr.
Results Reference
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Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus

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