CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 91 enrolled
Drug / intervention
LY2963016 +1 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/NCT01688635
NCT01688635Phase 1Completed

Comparative Pharmacokinetics and Pharmacodynamics of LY2963016 and US-Approved Lantus® After Single-Dose Subcutaneous Administration to Healthy Subjects

Eli Lilly and Company·interventional·Posted Sep 20, 2012·Updated Oct 7, 2014

In Brief

A Phase 1 clinical trial evaluating LY2963016 and US Approved Lantus for Healthy. Completed, enrolled 91 participants across 1 site.

Detailed Summary

The purpose of this study is to compare the pharmacokinetics and pharmacodynamics of LY2963016 and US-approved Lantus®. The study involves four single injections; two doses of LY2963016 and two doses of US-approved Lantus®. The study will have 4 periods. In each period, a single injection will be administered before undergoing a euglycemic clamp that lasts for 24 hours. There will be at least a 7 day washout between each period. Side effects will be documented. Study participation is expected to last up to 14 weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHealthy
CountriesSingapore
Collaborators--

Timeline

Phase 1CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 20, 2012
Enrollment StartSep 1, 2012
Primary CompletionFeb 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 13.8 years ago

Interventions

LY2963016drug

Administered subcutaneously

US Approved Lantusdrug

Administered subcutaneously