At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 47 enrolled
Drug / intervention
LY2405319 +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.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY2405319 With 28 Days of Subcutaneous Injections in Patients With Type 2 Diabetes Mellitus
In Brief
A Phase 1 clinical trial evaluating LY2405319 and Placebo for Diabetes Mellitus, Type 2. Completed, enrolled 47 participants across 7 sites.
Detailed Summary
The main purpose of this study was to evaluate the safety and tolerability of LY2405319. It was given as a daily injection under the skin to participants with type 2 diabetes mellitus (T2DM) for 28 days. This study determined how long the drug stays in the body and how it affects blood sugar levels. After screening, the study lasted about 2 months for each participant. Participants continued their prestudy regimen of diet and exercise alone or in combination with metformin.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartApr 2009
Primary CompletionJun 2009
Study CompletionDec 2009
First PostedJun 2013
TodayJul 2026
First PostedJun 5, 2013
Enrollment StartApr 1, 2009
Primary CompletionJun 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.1 years ago
Interventions
LY2405319drug
Administered SC
Placebodrug
Administered SC