At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 135 enrolled
Drug / intervention
Insulin lispro +4 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, Double Blind, 2-Way Crossover Safety and Efficacy Study of Subcutaneously Injected Prandial Insulins: Lispro-PH20 or Aspart-PH20 Compared to Insulin Lispro (Humalog®) in Patients With Type 1 Diabetes
In Brief
A Phase 2 clinical trial evaluating Insulin lispro, recombinant human hyaluronidase PH20, and 3 other interventions for Diabetes Mellitus, Type 1. Completed, enrolled 135 participants across 19 sites.
Detailed Summary
The purpose of the study is to compare Humalog (Insulin lispro)-recombinant human hyaluronidase (rHuPH20) or Novolog (Insulin aspart)-rHuPH20 to Humalog (Insulin lispro) for the treatment of Type 1 Diabetes Mellitus (T1DM) in basal-bolus therapy.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
Enrollment StartAug 2010
First PostedSep 2010
Primary CompletionAug 2011
TodayJul 2026
First PostedSep 2, 2010
Enrollment StartAug 1, 2010
Primary CompletionAug 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 15.8 years ago
Interventions
Insulin lisprodrug
recombinant human hyaluronidase PH20drug
Insulin aspartdrug
Insulin glulisinedrug
Insulin glarginedrug