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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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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

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 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
U.S. FDA Resources

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®



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) ]


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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

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

Publications of Results:
Responsible Party: Medical University of Warsaw
ClinicalTrials.gov Identifier: NCT01678235     History of Changes
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:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Insulin glulisine
Insulin
Insulin Aspart
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs