CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 22 enrolled
Drug / intervention
Insulin Lispro +2 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.

Search/NCT00862849
NCT00862849Phase 1Completed

Phase 1, Randomized, Double-Blind, Pharmacokinetic and Glucodynamic 6-Way Crossover Study of SC Administered Insulin Lispro With Recombinant Human Hyaluronidase (rHuPH20) and Regular Human Insulin With Recombinant Human Hyaluronidase (rHuPH20) Compared to Insulin Lispro Alone in Healthy Volunteers

Halozyme Therapeutics·interventional·Posted Mar 17, 2009·Updated Jul 22, 2014

In Brief

A Phase 1 clinical trial evaluating Insulin Lispro, Regular Human Insulin, and 1 other intervention for Diabetes Mellitus. Completed, enrolled 22 participants across 1 site.

Detailed Summary

Insulin lispro and regular human insulin are Food and Drug Administration (FDA)-approved medications 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 will be co-administered with both insulin lispro and regular human insulin in order to determine if it improves the absorption of these insulins to more closely mimic the body's natural increase in insulin in response to a meal.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 17, 2009
Enrollment StartMar 1, 2009
Primary CompletionJun 1, 2009
Study CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 17.3 years ago

Interventions

Insulin Lisprodrug

Regular Human Insulindrug

rHuPH20drug