NCT01678235

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 28, 2012

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 3, 2012

Completed
Last Updated

October 7, 2014

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

August 28, 2012

Last Update Submit

October 6, 2014

Conditions

Type 1 Diabetes Mellitus

Keywords

diabetesinsulin pumpglulisineaspartglycemic index

Outcome Measures

Primary Outcomes (1)

  • Postprandial glycemia

    baseline, 30, 60, 90, 120 and 180 minutes after the breakfast

Secondary Outcomes (4)

  • Hypoglycemia episodes

    3-h study period

  • Glucose Area Under the Curve (AUC)

    3-h study period

  • Mean amplitude of glycemic excursion (MAGE)

    3-h study period

  • Difference between the maximum and baseline glycemia

    3-h study period

Other Outcomes (1)

  • Questionnaire: Glycemic Index Knowledge

    each subject was asked to fullfill the questionnaire before entering the study (day one)

Study Arms (2)

GLU_ASP

EXPERIMENTAL

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 glulisineDrug: Insulin aspart

ASP_GLU

EXPERIMENTAL

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 glulisineDrug: Insulin aspart

Interventions

Insulin glulisineDRUG
Also known as: Apidra®
ASP_GLUGLU_ASP
Insulin aspartDRUG
Also known as: NovoRapid®
ASP_GLUGLU_ASP

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Type 1 diabetes mellitus
  • CSII for at least 3 months
  • Duration of diabetes \> 1 years
  • Informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics, Medical University of Warsaw, Poland

Warsaw, 01-184, Poland

Location

Related 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.

    PMID: 24412929RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus

Interventions

insulin glulisineInsulin Aspart

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-ActingInsulinsPancreatic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Katarzyna Dżygało, MD

    Department of Pediatrics, Medical University of Warsaw, Poland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2012

First Posted

September 3, 2012

Study Start

September 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 7, 2014

Record last verified: 2012-08

Locations

PL(1)