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

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® |
- Postprandial glycemia [ Time Frame: baseline, 30, 60, 90, 120 and 180 minutes after the breakfast ]
- Hypoglycemia episodes [ Time Frame: 3-h study period ]Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms
- Glucose Area Under the Curve (AUC) [ Time Frame: 3-h study period ]based on continuous glucose monitoring system
- Mean amplitude of glycemic excursion (MAGE) [ Time Frame: 3-h study period ]
- Difference between the maximum and baseline glycemia [ Time Frame: 3-h study period ]
- 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 |
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

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
Poland | |
Department of Pediatrics, Medical University of Warsaw, Poland | |
Warsaw, Poland, 01-184 |
Principal Investigator: | Katarzyna Dżygało, MD | Department of Pediatrics, Medical University of Warsaw, Poland |
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 |
diabetes insulin pump glulisine aspart glycemic index |
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 |