CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 20 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/NCT01600950
NCT01600950Phase 1Completed
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Pharmacodynamics of LY2963016 Compared to LANTUS® in Subjects With Type 1 Diabetes Mellitus

Eli Lilly and Company·interventional·Posted May 17, 2012·Updated Oct 7, 2014

In Brief

A Phase 1 clinical trial evaluating LY2963016 and Lantus for Diabetes Mellitus, Type 1. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The study involves a single injection of LY2963016 and a single injection of Lantus, on 2 separate occasions in participants with type I diabetes. Following each dose, participants will undergo a glucose clamp which lasts for 42 hours each time. There will be at least 7 days between the two periods, during which time there will be no study treatment, but participants will resume their regular therapy. The duration of this study can be up to 9.5 weeks. The purposes of this study are to understand how the blood sugar lowering effect of LY2963016 compares to that of Lantus, and to determine how LY2963016 and Lantus are metabolized by participants with type I diabetes.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 1
CountriesGermany
Collaborators--

Timeline

Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 17, 2012
Enrollment StartMay 1, 2012
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 14.1 years ago

Interventions

LY2963016drug

Single 0.3 U/kg dose administered subcutaneously

Lantusdrug

Single 0.3 U/kg dose administered subcutaneously