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

This study is currently recruiting participants.
Verified August 2012 by Medical University of Warsaw
Sponsor:
Information provided by (Responsible Party):
Medical University of Warsaw
ClinicalTrials.gov Identifier:
NCT01678235
First received: August 28, 2012
Last updated: September 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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 Intervention Phase
Type 1 Diabetes Mellitus
 Drug: Insulin glulisine
Drug: Insulin aspart
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Warsaw:

Primary Outcome Measures:
  • Postprandial glycemia [ Time Frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hypoglycemia episodes [ Time Frame: 3-h study period ] [ Designated as safety issue: Yes ]
    Hypoglycemia was defined as a PG concentration below 60 mg/dl with or without symptoms

  • Glucose Area Under the Curve (AUC) [ Time Frame: 3-h study period ] [ Designated as safety issue: Yes ]
    based on continuous glucose monitoring system

  • Mean amplitude of glycemic excursion (MAGE) [ Time Frame: 3-h study period ] [ Designated as safety issue: Yes ]
  • Difference between the maximum and baseline glycemia [ Time Frame: 3-h study period ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Questionnaire: Glycemic Index Knowledge [ Time Frame: each subject was asked to fullfill the questionnaire before entering the study (day one) ] [ Designated as safety issue: No ]

Estimated Enrollment: 63
Study Start Date: September 2011
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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®

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).

  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01678235

Contacts
Contact: Katarzyna Dżygało, MD +48224523284 k.dzygalo@gmail.com
Contact: Agnieszka Szypowska, A. Professor +48224523284 agnieszka.szypowska@gmail.com

Locations
Poland
Department of Pediatrics, Medical University of Warsaw, Poland Recruiting
Warsaw, Poland, 01-184
Principal Investigator: Katarzyna Dżygało, MD            
Sponsors and Collaborators
Medical University of Warsaw
Investigators
Principal Investigator: Katarzyna Dżygało, MD Department of Pediatrics, Medical University of Warsaw, Poland
  More Information

No publications provided

Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01678235     History of Changes
Other Study ID Numbers: Glulisine_Aspart
Study First Received: August 28, 2012
Last Updated: September 3, 2012
Health Authority: Poland: Ethics Committee

Keywords provided by Medical University of Warsaw:
diabetes
insulin pump
glulisine
aspart
glycemic index

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

ClinicalTrials.gov processed this record on June 18, 2013