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

Type 1 Diabetes Mellitus Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01678235
• Other study ID #: Glulisine_Aspart
• Status: Completed
• Phase: Phase 4
• First received: August 28, 2012
• Last updated: October 6, 2014
• Start date: September 2011
• Est. completion date: September 2012

Study information

• Verified date: August 2012
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Health authority: Poland: Ethics Committee
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years to 18 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Drug:
• Insulin glulisine

• Insulin aspart

Locations

Country	Name	City	State
Poland	Department of Pediatrics, Medical University of Warsaw, Poland	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Questionnaire: Glycemic Index Knowledge		each subject was asked to fullfill the questionnaire before entering the study (day one)	No
Primary	Postprandial glycemia		baseline, 30, 60, 90, 120 and 180 minutes after the breakfast	Yes
Secondary	Hypoglycemia episodes	Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms	3-h study period	Yes
Secondary	Glucose Area Under the Curve (AUC)	based on continuous glucose monitoring system	3-h study period	Yes
Secondary	Mean amplitude of glycemic excursion (MAGE)		3-h study period	Yes
Secondary	Difference between the maximum and baseline glycemia		3-h study period	Yes