At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 641 enrolled
Drug / intervention
LY2605541 +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 Comparison of LY2605541 Versus Human Insulin NPH as Basal Insulin Treatment in Insulin-Naïve Patients With Type 2 Diabetes Mellitus Not Adequately Controlled With 2 or More Oral Antihyperglycemic Medications: An Open-Label, Randomized Study
In Brief
A Phase 3 clinical trial evaluating LY2605541, Human Insulin NPH, and 1 other intervention for Diabetes Mellitus, Type 2. Completed, enrolled 641 participants across 63 sites in 11 countries.
Detailed Summary
The purpose of this study is to compare LY2605541 and human insulin isophane suspension (NPH) using the following measures for participants treated for up to 26 weeks: * Change in participants' overall blood sugar control * The rate of night time low blood sugar episodes * The number of participants that reach blood sugar targets without low night time blood sugar episodes * The total number of low blood sugar episodes reported
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetes Mellitus, Type 2
CountriesArgentina, Canada, Czechia, Germany, Hungary, Mexico, Poland, Puerto Rico, South Korea, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedFeb 2013
Enrollment StartMar 2013
Primary CompletionMay 2014
TodayJul 2026
First PostedFeb 13, 2013
Enrollment StartMar 1, 2013
Primary CompletionMay 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 13.4 years ago
Interventions
LY2605541drug
Human Insulin NPHdrug
Oral Antihyperglycemic Medications (OAM)drug