Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01678235
Recruitment Status : Completed
First Posted : September 3, 2012
Last Update Posted : October 7, 2014
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus Drug: Insulin glulisine Drug: Insulin aspart Phase 4

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : September 2011
Actual Primary Completion Date : September 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 glulisine
Other Name: Apidra®

Drug: Insulin aspart
Other Name: NovoRapid®
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 glulisine
Other Name: Apidra®

Drug: Insulin aspart
Other Name: NovoRapid®


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Postprandial glycemia [ Time Frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast ]

Secondary Outcome Measures :
  1. Hypoglycemia episodes [ Time Frame: 3-h study period ]
    Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms

  2. Glucose Area Under the Curve (AUC) [ Time Frame: 3-h study period ]
    based on continuous glucose monitoring system

  3. Mean amplitude of glycemic excursion (MAGE) [ Time Frame: 3-h study period ]
  4. Difference between the maximum and baseline glycemia [ Time Frame: 3-h study period ]

Other Outcome Measures:
  1. Questionnaire: Glycemic Index Knowledge [ Time Frame: each subject was asked to fullfill the questionnaire before entering the study (day one) ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01678235


Locations
Layout table for location information
Poland
Department of Pediatrics, Medical University of Warsaw, Poland
Warsaw, Poland, 01-184
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Layout table for investigator information
Principal Investigator: Katarzyna Dżygało, MD Department of Pediatrics, Medical University of Warsaw, Poland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

Layout table for additonal information
Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01678235    
Other Study ID Numbers: Glulisine_Aspart
First Posted: September 3, 2012    Key Record Dates
Last Update Posted: October 7, 2014
Last Verified: August 2012
Keywords provided by Medical University of Warsaw:
diabetes
insulin pump
glulisine
aspart
glycemic index
Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin
Insulin, Globin Zinc
Insulin Aspart
Insulin glulisine
Hypoglycemic Agents
Physiological Effects of Drugs