At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 80 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.
Bioequivalence Study Comparing the Pharmacokinetics and Pharmacodynamics of LY2963016 With Insulin Glargine in Healthy Volunteers
In Brief
A Phase 1 clinical trial evaluating LY2963016 and Lantus for Diabetes Mellitus. Completed, enrolled 80 participants across 1 site.
Detailed Summary
The purposes of this study are to determine the pharmacokinetics and pharmacodynamics of LY2963016 compared to those of basal insulin. The study will also gather information on the safety and tolerability of LY2963016 in healthy participants. Each study period will be approximately 8.5 days (1.5 days for treatment and 7 day washout period). There are 4 study periods.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus
CountriesSouth Africa
Collaborators--
Timeline
Phase 1CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2011
First PostedNov 2011
Primary CompletionJul 2012
TodayJul 2026
First PostedNov 22, 2011
Enrollment StartNov 1, 2011
Primary CompletionJul 1, 2012
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 14.6 years ago
Interventions
LY2963016drug
Administered subcutaneously
Lantusdrug
Administered subcutaneously