At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 16 enrolled
Drug / intervention
insulin glulisine +1 moredrug
Likely dose
insulin glulisine 100 unitsfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 4 Crossover Study Comparing the Effect of Insulin Glulisine to Insulin Aspart on Breakfast Post Prandial Blood Glucose Levels in Prepubertal Children With Type 1 Diabetes Mellitus on Multiple Daily Insulin Injection Therapy
In Brief
A Phase 4 clinical trial evaluating insulin glulisine and insulin aspart for Type 1 Diabetes Mellitus. Completed, enrolled 16 participants across 1 site.
Detailed Summary
To determine whether insulin glulisine decreases the breakfast post prandial glycemic excursion in comparison to insulin aspart.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsType 1 Diabetes Mellitus
CountriesUnited States
CollaboratorsHelen DeVos Children's Hospital
Timeline
Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2009
First PostedJun 2009
Primary CompletionJan 2012
TodayJul 2026
First PostedJun 4, 2009
Enrollment StartJun 1, 2009
Primary CompletionJan 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 17.1 years ago
Interventions
insulin glulisinedrug
Insulin glulisine (Apidra®) Sanofi-Aventis; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days
insulin aspartdrug
Insulin aspart (NovoLog®) Novo Nordisk; U100 (100 units/mL) 10 mL vials Prescribed dosage to be given subcutaneously at breakfast for a total of ten days.