At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 48 enrolled
Drug / intervention
Insulin Lispro +3 moredrug
Likely dose
Not stated in 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.
A Phase II, Randomized, Open Label, 2-Way Crossover, Safety Study of Subcutaneously Injected Prandial INSULIN-PH20 NP Compared to Insulin Analog Injection in Patients With Type 1 Diabetes
In Brief
A Phase 2 clinical trial evaluating Insulin Lispro, regular human insulin, and 2 other interventions for Diabetes Mellitus, Type 1. Completed, enrolled 48 participants across 8 sites.
Detailed Summary
Insulin lispro is approved by the Food and Drug Administration (FDA) for the treatment of diabetes mellitus. Recombinant human hyaluronidase (rHuPH20) is approved by the FDA as an aid to the absorption and dispersion of other injectable drugs. In this study, rHuPH20 combined with a non-preserved (NP) formulation of regular human insulin (INSULIN-PH20 NP) will be compared to insulin lispro with respect to absorption and action of insulin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 2009
Enrollment StartMay 2009
Primary CompletionFeb 2010
Study CompletionApr 2010
TodayJul 2026
First PostedApr 17, 2009
Enrollment StartMay 1, 2009
Primary CompletionFeb 1, 2010
Study CompletionApr 1, 2010
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 17.2 years ago
Interventions
Insulin Lisprodrug
regular human insulindrug
recombinant human hyaluronidase PH20drug
Insulin glarginedrug