At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 759 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, Double-Blind Comparison of a Long-Acting Basal Insulin Analog LY2963016 to Lantus in Adult Patients With Type 2 Diabetes Mellitus: The ELEMENT 2 Study
In Brief
A Phase 3 clinical trial evaluating LY2963016, Lantus, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 759 participants across 62 sites in 12 countries.
Detailed Summary
The main purpose of this study is to compare the effectiveness and safety of LY2963016 versus Lantus in controlling blood sugar levels in combination with two or more oral diabetes medications.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesCzechia, France, Germany, Greece, Hungary, Mexico, Poland, Puerto Rico, South Korea, Spain, Taiwan, United States
CollaboratorsBoehringer Ingelheim
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedAug 2011
Enrollment StartSep 2011
Primary CompletionSep 2012
TodayJul 2026
First PostedAug 22, 2011
Enrollment StartSep 1, 2011
Primary CompletionSep 1, 2012
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 14.9 years ago
Interventions
LY2963016drug
Administered subcutaneously
Lantusdrug
Administered subcutaneously
OAMsdrug
Administered orally