At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 493 enrolled
Drug / intervention
LY2963016 +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.
A Prospective, Randomized, Open-Label Comparison of a Long-Acting Basal Insulin Analog LY2963016 to LANTUS® in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 5 Study
In Brief
A Phase 3 clinical trial evaluating LY2963016, LANTUS®, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 493 participants across 44 sites in 7 countries.
Detailed Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as LY2963016 as compared to LANTUS® in adults with type 2 diabetes mellitus who are on 2 or more oral antihyperglycemic medications (OAMs).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesIndia, Puerto Rico, Russia, South Korea, Taiwan, Turkey (Türkiye), United States
CollaboratorsBoehringer Ingelheim
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartDec 2014
Primary CompletionJul 2016
TodayJul 2026
First PostedNov 27, 2014
Enrollment StartDec 1, 2014
Primary CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 11.6 years ago
Interventions
LY2963016drug
Administered SC
LANTUS®drug
Administered SC
Oral Antihyperglycemic Medicationdrug
Administered as per standard-of-care.